Antipsychotic safe, effective for resistant depression in phase 3 trial

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Fri, 05/27/2022 - 11:48

 

Cariprazine (Vraylar) is a safe and effective adjunctive treatment for adults with major depressive disorder (MDD) who have an inadequate response to antidepressant monotherapy, new results from a phase 3 study show.

Already approved by the U.S. Food and Drug Administration to treat adults with schizophrenia and manic, mixed, or depressive episodes of bipolar I disorder, cariprazine is under investigation as an add-on therapy for MDD.

“Even patients who appear to be nonresponsive to standard antidepressant drugs have a very good chance of responding” to cariprazine, lead study author Gary Sachs, MD, associate clinical professor of psychiatry at Massachusetts General Hospital, Boston, told this news organization.

associate clinical professor of psychiatry at Massachusetts General Hospital, Boston
Dr. Gary Sachs

He noted that cariprazine, which is a partial agonist at D2 and D3, as well as 5-HT1A, “is an entirely different class” of drugs.

“It’s worth understanding how to use drugs like cariprazine and expanding our nomenclature; instead of referring to these drugs as atypical antipsychotics, perhaps referring to them as atypical antidepressants makes more sense,” Dr. Sachs said.

The findings were presented at the annual meeting of the American Psychiatric Association.
 

More options critical

MDD is among the most common psychiatric disorders in the United States. In 2020, an estimated 21 million adults had at least one major depressive episode.

Previous research has shown almost half of patients with MDD do not experience satisfactory results from their current treatment regimen. Therefore, research on more options for patients is critical, Dr. Sachs said.

Results from a previously published placebo-controlled study showed adjunctive treatment with cariprazine at 2-mg to 4.5-mg per day doses was more effective than placebo in improving depressive symptoms in adults with MDD.

The new analysis included patients with MDD and an inadequate response to antidepressant therapy, including selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors (SNRIs), or tricyclic antidepressants. They were recruited from 116 centers in the United States and Europe.

Dr. Sachs noted that a nonresponse to an adequate dose of an antidepressant typically means having less than a 50% improvement over 6 weeks or more.

Researchers randomly assigned the patients to oral cariprazine 1.5 mg/day, cariprazine 3 mg/day, or placebo. All continued to take their antidepressant monotherapy.

The analysis included 757 mostly White participants (mean age, 44.8 years; 73.4% women). All had experienced depression for a “huge” part of their life (average, about 14 years), “not to mention their adult life,” said Dr. Sachs.

In addition, at the start of the study, the participants had been depressed for almost 8 months on average.

The primary endpoint was change at week 6 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. The mean baseline MADRS total score was 32.5.

Less is sometimes more

Results showed a significantly greater mean reduction in MADRS total score for cariprazine 1.5 mg/day vs. placebo at week 6 (P = .005). Significant differences from placebo were observed as early as week 2 and were maintained at week 4, as well as week 6.

“I can say with great confidence that the 1.5-mg dose met all the standards for efficacy,” Dr. Sachs said.

However, this was not the case for the 3-mg/day dose. Although there was a numerically greater reduction in MADRS total score for this dosage of the drug vs. placebo at week 6, the difference was not statistically significant (P = .07).

At week 6, more patients taking the active drug at 1.5 mg/day than placebo responded to treatment, defined as 50% or greater reduction in MADRS total score (44% vs. 34.9%, respectively; P < .05).

Researchers also assessed scores on the Clinical Global Impressions, finding significantly greater score improvement for both the 1.5-mg/day (P = .0026) and 3-mg/day (P =.0076) groups vs. the placebo group.

Improvement at week 6 in mean total score on the Hamilton Depression Rating Scale (HAM-17) reached nominal significance for cariprazine 1.5 mg/day vs. placebo – but not for 3 mg/day.

The results of this “high-quality” double-blind, randomized, controlled, parallel group study provide “what I regard as proven efficacy,” Dr. Sachs said.

He added that the investigational drug was also relatively safe. “The vast majority of patients tolerated it quite well,” he stressed. In addition, the drop-out rate because of adverse events was “quite low overall.”

The only adverse events (AEs) that occurred with the active treatment at a frequency of 5% or more and double that of placebo were akathisia and nausea. Changes in weight were relatively small, at less than 1 kg, in all treatment groups.

There was one serious AE in each active drug group, one of which was a kidney infection. There were two serious AEs reported in the placebo group, including one patient with multiple sclerosis. There were no deaths.

Dr. Sachs noted an advantage of cariprazine is its long half-life, which makes it more user-friendly because “it forgives you if you miss a dose or two.”

Drug manufacturer AbbVie’s supplemental New Drug Application for cariprazine is currently under review by the FDA for expanded use as adjunctive treatment of MDD. A decision by the agency is expected by the end of this year.

 

 

Another potential treatment option

Commenting on the findings, James Murrough, MD, PhD, associate professor of psychiatry and of neuroscience and director of the Depression and Anxiety Center for Discovery and Treatment at the Icahn School of Medicine at Mount Sinai, New York, said he welcomes research into additional treatments for MDD.

Dr. James Murrough
Dr. James Murrough

“Each medicine in a particular class has a unique pharmacology, so a larger number of medication options may help the clinician find a good match for a particular patient,” said Dr. Murrough, who was not involved with the research.

He noted cariprazine is “somewhat unique” among the dopamine modulators in “preferring interactions with the D3 receptor, one of many types of dopamine receptors.”

Although the study results showed cariprazine was effective in MDD, it “does not entirely break new ground” because previous research has already established the drug’s efficacy as adjunctive therapy for patients with depression not responding to a standard antidepressant, said Dr. Murrough.

He also noted that the lower dose, but not the higher dose, of the drug was found to be significantly beneficial for patients, compared with placebo.

“This is a good reminder that higher doses of a medication are not always better,” Dr. Murrough said.

The study was funded by AbbVie. Dr. Sachs is a full-time employee of Signant Health, which conducted the training and quality control for this study. Dr. Murrough has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Cariprazine (Vraylar) is a safe and effective adjunctive treatment for adults with major depressive disorder (MDD) who have an inadequate response to antidepressant monotherapy, new results from a phase 3 study show.

Already approved by the U.S. Food and Drug Administration to treat adults with schizophrenia and manic, mixed, or depressive episodes of bipolar I disorder, cariprazine is under investigation as an add-on therapy for MDD.

“Even patients who appear to be nonresponsive to standard antidepressant drugs have a very good chance of responding” to cariprazine, lead study author Gary Sachs, MD, associate clinical professor of psychiatry at Massachusetts General Hospital, Boston, told this news organization.

associate clinical professor of psychiatry at Massachusetts General Hospital, Boston
Dr. Gary Sachs

He noted that cariprazine, which is a partial agonist at D2 and D3, as well as 5-HT1A, “is an entirely different class” of drugs.

“It’s worth understanding how to use drugs like cariprazine and expanding our nomenclature; instead of referring to these drugs as atypical antipsychotics, perhaps referring to them as atypical antidepressants makes more sense,” Dr. Sachs said.

The findings were presented at the annual meeting of the American Psychiatric Association.
 

More options critical

MDD is among the most common psychiatric disorders in the United States. In 2020, an estimated 21 million adults had at least one major depressive episode.

Previous research has shown almost half of patients with MDD do not experience satisfactory results from their current treatment regimen. Therefore, research on more options for patients is critical, Dr. Sachs said.

Results from a previously published placebo-controlled study showed adjunctive treatment with cariprazine at 2-mg to 4.5-mg per day doses was more effective than placebo in improving depressive symptoms in adults with MDD.

The new analysis included patients with MDD and an inadequate response to antidepressant therapy, including selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors (SNRIs), or tricyclic antidepressants. They were recruited from 116 centers in the United States and Europe.

Dr. Sachs noted that a nonresponse to an adequate dose of an antidepressant typically means having less than a 50% improvement over 6 weeks or more.

Researchers randomly assigned the patients to oral cariprazine 1.5 mg/day, cariprazine 3 mg/day, or placebo. All continued to take their antidepressant monotherapy.

The analysis included 757 mostly White participants (mean age, 44.8 years; 73.4% women). All had experienced depression for a “huge” part of their life (average, about 14 years), “not to mention their adult life,” said Dr. Sachs.

In addition, at the start of the study, the participants had been depressed for almost 8 months on average.

The primary endpoint was change at week 6 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. The mean baseline MADRS total score was 32.5.

Less is sometimes more

Results showed a significantly greater mean reduction in MADRS total score for cariprazine 1.5 mg/day vs. placebo at week 6 (P = .005). Significant differences from placebo were observed as early as week 2 and were maintained at week 4, as well as week 6.

“I can say with great confidence that the 1.5-mg dose met all the standards for efficacy,” Dr. Sachs said.

However, this was not the case for the 3-mg/day dose. Although there was a numerically greater reduction in MADRS total score for this dosage of the drug vs. placebo at week 6, the difference was not statistically significant (P = .07).

At week 6, more patients taking the active drug at 1.5 mg/day than placebo responded to treatment, defined as 50% or greater reduction in MADRS total score (44% vs. 34.9%, respectively; P < .05).

Researchers also assessed scores on the Clinical Global Impressions, finding significantly greater score improvement for both the 1.5-mg/day (P = .0026) and 3-mg/day (P =.0076) groups vs. the placebo group.

Improvement at week 6 in mean total score on the Hamilton Depression Rating Scale (HAM-17) reached nominal significance for cariprazine 1.5 mg/day vs. placebo – but not for 3 mg/day.

The results of this “high-quality” double-blind, randomized, controlled, parallel group study provide “what I regard as proven efficacy,” Dr. Sachs said.

He added that the investigational drug was also relatively safe. “The vast majority of patients tolerated it quite well,” he stressed. In addition, the drop-out rate because of adverse events was “quite low overall.”

The only adverse events (AEs) that occurred with the active treatment at a frequency of 5% or more and double that of placebo were akathisia and nausea. Changes in weight were relatively small, at less than 1 kg, in all treatment groups.

There was one serious AE in each active drug group, one of which was a kidney infection. There were two serious AEs reported in the placebo group, including one patient with multiple sclerosis. There were no deaths.

Dr. Sachs noted an advantage of cariprazine is its long half-life, which makes it more user-friendly because “it forgives you if you miss a dose or two.”

Drug manufacturer AbbVie’s supplemental New Drug Application for cariprazine is currently under review by the FDA for expanded use as adjunctive treatment of MDD. A decision by the agency is expected by the end of this year.

 

 

Another potential treatment option

Commenting on the findings, James Murrough, MD, PhD, associate professor of psychiatry and of neuroscience and director of the Depression and Anxiety Center for Discovery and Treatment at the Icahn School of Medicine at Mount Sinai, New York, said he welcomes research into additional treatments for MDD.

Dr. James Murrough
Dr. James Murrough

“Each medicine in a particular class has a unique pharmacology, so a larger number of medication options may help the clinician find a good match for a particular patient,” said Dr. Murrough, who was not involved with the research.

He noted cariprazine is “somewhat unique” among the dopamine modulators in “preferring interactions with the D3 receptor, one of many types of dopamine receptors.”

Although the study results showed cariprazine was effective in MDD, it “does not entirely break new ground” because previous research has already established the drug’s efficacy as adjunctive therapy for patients with depression not responding to a standard antidepressant, said Dr. Murrough.

He also noted that the lower dose, but not the higher dose, of the drug was found to be significantly beneficial for patients, compared with placebo.

“This is a good reminder that higher doses of a medication are not always better,” Dr. Murrough said.

The study was funded by AbbVie. Dr. Sachs is a full-time employee of Signant Health, which conducted the training and quality control for this study. Dr. Murrough has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

 

Cariprazine (Vraylar) is a safe and effective adjunctive treatment for adults with major depressive disorder (MDD) who have an inadequate response to antidepressant monotherapy, new results from a phase 3 study show.

Already approved by the U.S. Food and Drug Administration to treat adults with schizophrenia and manic, mixed, or depressive episodes of bipolar I disorder, cariprazine is under investigation as an add-on therapy for MDD.

“Even patients who appear to be nonresponsive to standard antidepressant drugs have a very good chance of responding” to cariprazine, lead study author Gary Sachs, MD, associate clinical professor of psychiatry at Massachusetts General Hospital, Boston, told this news organization.

associate clinical professor of psychiatry at Massachusetts General Hospital, Boston
Dr. Gary Sachs

He noted that cariprazine, which is a partial agonist at D2 and D3, as well as 5-HT1A, “is an entirely different class” of drugs.

“It’s worth understanding how to use drugs like cariprazine and expanding our nomenclature; instead of referring to these drugs as atypical antipsychotics, perhaps referring to them as atypical antidepressants makes more sense,” Dr. Sachs said.

The findings were presented at the annual meeting of the American Psychiatric Association.
 

More options critical

MDD is among the most common psychiatric disorders in the United States. In 2020, an estimated 21 million adults had at least one major depressive episode.

Previous research has shown almost half of patients with MDD do not experience satisfactory results from their current treatment regimen. Therefore, research on more options for patients is critical, Dr. Sachs said.

Results from a previously published placebo-controlled study showed adjunctive treatment with cariprazine at 2-mg to 4.5-mg per day doses was more effective than placebo in improving depressive symptoms in adults with MDD.

The new analysis included patients with MDD and an inadequate response to antidepressant therapy, including selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors (SNRIs), or tricyclic antidepressants. They were recruited from 116 centers in the United States and Europe.

Dr. Sachs noted that a nonresponse to an adequate dose of an antidepressant typically means having less than a 50% improvement over 6 weeks or more.

Researchers randomly assigned the patients to oral cariprazine 1.5 mg/day, cariprazine 3 mg/day, or placebo. All continued to take their antidepressant monotherapy.

The analysis included 757 mostly White participants (mean age, 44.8 years; 73.4% women). All had experienced depression for a “huge” part of their life (average, about 14 years), “not to mention their adult life,” said Dr. Sachs.

In addition, at the start of the study, the participants had been depressed for almost 8 months on average.

The primary endpoint was change at week 6 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. The mean baseline MADRS total score was 32.5.

Less is sometimes more

Results showed a significantly greater mean reduction in MADRS total score for cariprazine 1.5 mg/day vs. placebo at week 6 (P = .005). Significant differences from placebo were observed as early as week 2 and were maintained at week 4, as well as week 6.

“I can say with great confidence that the 1.5-mg dose met all the standards for efficacy,” Dr. Sachs said.

However, this was not the case for the 3-mg/day dose. Although there was a numerically greater reduction in MADRS total score for this dosage of the drug vs. placebo at week 6, the difference was not statistically significant (P = .07).

At week 6, more patients taking the active drug at 1.5 mg/day than placebo responded to treatment, defined as 50% or greater reduction in MADRS total score (44% vs. 34.9%, respectively; P < .05).

Researchers also assessed scores on the Clinical Global Impressions, finding significantly greater score improvement for both the 1.5-mg/day (P = .0026) and 3-mg/day (P =.0076) groups vs. the placebo group.

Improvement at week 6 in mean total score on the Hamilton Depression Rating Scale (HAM-17) reached nominal significance for cariprazine 1.5 mg/day vs. placebo – but not for 3 mg/day.

The results of this “high-quality” double-blind, randomized, controlled, parallel group study provide “what I regard as proven efficacy,” Dr. Sachs said.

He added that the investigational drug was also relatively safe. “The vast majority of patients tolerated it quite well,” he stressed. In addition, the drop-out rate because of adverse events was “quite low overall.”

The only adverse events (AEs) that occurred with the active treatment at a frequency of 5% or more and double that of placebo were akathisia and nausea. Changes in weight were relatively small, at less than 1 kg, in all treatment groups.

There was one serious AE in each active drug group, one of which was a kidney infection. There were two serious AEs reported in the placebo group, including one patient with multiple sclerosis. There were no deaths.

Dr. Sachs noted an advantage of cariprazine is its long half-life, which makes it more user-friendly because “it forgives you if you miss a dose or two.”

Drug manufacturer AbbVie’s supplemental New Drug Application for cariprazine is currently under review by the FDA for expanded use as adjunctive treatment of MDD. A decision by the agency is expected by the end of this year.

 

 

Another potential treatment option

Commenting on the findings, James Murrough, MD, PhD, associate professor of psychiatry and of neuroscience and director of the Depression and Anxiety Center for Discovery and Treatment at the Icahn School of Medicine at Mount Sinai, New York, said he welcomes research into additional treatments for MDD.

Dr. James Murrough
Dr. James Murrough

“Each medicine in a particular class has a unique pharmacology, so a larger number of medication options may help the clinician find a good match for a particular patient,” said Dr. Murrough, who was not involved with the research.

He noted cariprazine is “somewhat unique” among the dopamine modulators in “preferring interactions with the D3 receptor, one of many types of dopamine receptors.”

Although the study results showed cariprazine was effective in MDD, it “does not entirely break new ground” because previous research has already established the drug’s efficacy as adjunctive therapy for patients with depression not responding to a standard antidepressant, said Dr. Murrough.

He also noted that the lower dose, but not the higher dose, of the drug was found to be significantly beneficial for patients, compared with placebo.

“This is a good reminder that higher doses of a medication are not always better,” Dr. Murrough said.

The study was funded by AbbVie. Dr. Sachs is a full-time employee of Signant Health, which conducted the training and quality control for this study. Dr. Murrough has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Depressed patients respond faster to IV ketamine than intranasal ketamine

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NEW ORLEANS – New research reveals that patients with treatment-resistant depression who were treated with repeated intravenous ketamine show no significant differences in achieving response or remission, compared with those receiving the intranasal formulation of the drug, esketamine – although fewer treatments appear necessary with the intravenous formulation.

This is one of the first studies to compare the efficacy of IV and intranasal ketamine, and the results give us some indication that, if you treat with IV, you might get a faster response, although at the end, the responses are similar,” said first author Balwinder Singh, MD, of the department of psychiatry and psychology, Mayo Clinic, in Rochester, Minn.

Dr. Balwinder Singh, Department of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota
courtesy Balwinder Singh
Dr. Balwinder Singh

The findings were presented at the annual meeting of the American Psychiatric Association.

Commenting on the study, Roger S. McIntyre, MD, underscored that “this is an important study that addresses the priority questions that everyone wants to know – not only for clinical reasons, but economic reasons.” Dr. McIntyre, a professor of psychiatry and pharmacology at the University of Toronto, and head of the university’s mood disorders psychopharmacology unit, said that “there are implications not only for clinical outcomes and cost, but also implementation because IV is obviously more demanding and complicated.”

As intravenous ketamine increasingly gained interest as a rapid-acting treatment for patients with severe, treatment-resistant depression, the introduction of a more convenient intranasal formulation was seen as a welcome improvement and received approval from the Food and Drug Administration in 2019. However, while the approval ushered in more coverage by insurance companies, the treatment can still be expensive. Intravenous ketamine does not have FDA approval.

With a lack of studies in the real-world setting comparing efficacy of the two formulations, Dr. Singh and his colleagues conducted the observational study, evaluating the responses of 62 adults with treatment-resistant depression who had received either up to six IV ketamine infusions of 0.5 mg/kg, infused over 40 minutes, or up to eight intranasal esketamine treatments of 56/84 mg, as approved by the FDA, at the Mayo Clinic Depression Center.

Of the patients, who had a mean age of 47 years, 59 had major depression and 3 had bipolar depression. Among them, 76% (47) received intravenous ketamine and 24% (15) received esketamine, which Dr. Singh noted reflected the higher number of patients included before esketamine received FDA approval. The patients had similar comorbidity profiles, with the intravenous ketamine group having a higher body mass index at baseline.

Overall, the patients all had significant improvement in their depression at the end of the acute phase of 4 weeks, with a mean change in on the 16-Item Quick Inventory of Depressive Symptomatology (QIDS-SR) scale of –8.6 from baseline (P < .001).

The overall remission rate was 38.7% and overall response rate was 58.1%. Those receiving intravenous ketamine had response and remission rates of 57.4% and 42.6%, versus response and remission rates of 60.0% and 26.7% among the esketamine group, which Dr. Singh said were not significant differences (P > .05).

However, the mean number of treatments necessary to achieve response in the intravenous ketamine group was just 2.3 versus 4.6 with esketamine, and the mean number of treatments to achieve remission were 2.5 versus 6.3, respectively (P = .008).

After a multivariate adjustment, the time to response was determined to be faster with intravenous ketamine versus esketamine (hazard ratio, 2.61; P = .05) and the time to remission was also faster (HR, 5.0; P = .02).

“What this means is you would need fewer treatments to achieve a response or remission with IV ketamine, so there could be an acceleration of patients’ antidepressant response,” Dr. Singh explained.

There were no significant differences between the groups in terms of side effects, and most patients tolerated the treatments well.

Dr. Singh noted the limitation of the study is that it was observational and included a small sample size. Nevertheless, when asked which he would choose if starting treatment when insurance was not an issue, Dr. Singh replied: “I would take patient preference into account, but certainly IV seems to have an advantage.”

Dr. Roger S. McIntyre, University of Toronto
Dr. Roger S. McIntyre

Dr. McIntyre noted that, though small, the study’s setting in a real world clinical environment is important.

“Obviously this is observational and not controlled, but the strength is that this involved a real-world cohort of patients and real world applications,” he said. “It’s difficult to have a true comparator head-to-head trial, so that makes this all the more important because it takes into consideration all of the complexities of real world patients.”

Dr. McIntyre emphasized that the study is not “the last word on the story because we need to see a larger sample and replication. But certainly they make an argument that IV ketamine may have an advantage over the speed of onset with intranasal ketamine, which will need to be either replicated or refuted, but it’s a great starting point in the conversation.”
 

 

 

Navigating patient preference

Robert Meisner, MD, founding medical director of the McLean Ketamine Service, Division of Psychiatric Neurotherapeutics, McLean Hospital, Harvard Medical School, in Boston, noted that wide-ranging factors may influence patient as well as clinician decisions about which ketamine treatment approach to use.

“When a patient appears to be equally well-suited for both interventions, I continue to be surprised by why one patient will indicate a preference for intranasal esketamine, while another will lean toward IV racemic ketamine,” he said in an interview.

“Some patients find esketamine’s clear and consistent protocol optimal for scheduling and navigating the logistics of daily life; others value the flexibility offered by certain evidence-based, racemic (IV) protocols,” he said. “Predicting who will prefer each treatment, even with the apparent temporal advantage with IV ketamine, is extremely difficult.”

Likewise, in terms of clinician preference, Dr. Meisner notes that key concerns may sway decisions.

“If I’m concerned with labile pressures or hypertension, for example, or if I have a patient with, say, Erlos Danlos Syndrome without a clear subtype, and hence, some risk of undiscovered aneurysmal vascular disease, I may lean toward racemic IV ketamine.”

On the other hand, “some patients find the simplicity and predictability of the maintenance esketamine protocol comforting and psychologically stabilizing,” he added. “Yet others find that their work or family’s erratic demands on their time make one of the evidence-based racemic regimens preferable – inasmuch as it integrates more flexibility and allows them to remain more fully engaged in the basic activities or work and family.”

Dr. Meisner noted the caveat that efforts to decide which method to use are often complicated by substantial misinformation.

“I can’t emphasize how much misinformation continues to abound regarding appropriate (evidence-based) and safe use of ketamine and esketamine,” he said. “Especially on the IV racemic side, there simply is no substantive evidence base for many of the claims that some providers are preaching.”

The confusion, driven in part by social media, “has diffused into sectors of the field and industry that one might assume are relatively immune (i.e., allied physicians, sophisticated payers, etc),” he added.

“In short, two mantra continue to apply,” Dr. Meisner said. “One – if it sounds too good to be true, it probably is; and two – in pharmacology and interventional psychiatry, we see remarkable progress and potential, but there simply is no such thing as a magic bullet.”

Dr. Singh and Dr. Meisner had no disclosures to report. Dr. McIntyre has received research grant support from Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/National Natural Science Foundation of China, and speaker/consultation fees from Lundbeck, Janssen, Alkermes,Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Abbvie, and Atai Life Sciences. Dr. McIntyre is a CEO of Braxia Scientific.

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NEW ORLEANS – New research reveals that patients with treatment-resistant depression who were treated with repeated intravenous ketamine show no significant differences in achieving response or remission, compared with those receiving the intranasal formulation of the drug, esketamine – although fewer treatments appear necessary with the intravenous formulation.

This is one of the first studies to compare the efficacy of IV and intranasal ketamine, and the results give us some indication that, if you treat with IV, you might get a faster response, although at the end, the responses are similar,” said first author Balwinder Singh, MD, of the department of psychiatry and psychology, Mayo Clinic, in Rochester, Minn.

Dr. Balwinder Singh, Department of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota
courtesy Balwinder Singh
Dr. Balwinder Singh

The findings were presented at the annual meeting of the American Psychiatric Association.

Commenting on the study, Roger S. McIntyre, MD, underscored that “this is an important study that addresses the priority questions that everyone wants to know – not only for clinical reasons, but economic reasons.” Dr. McIntyre, a professor of psychiatry and pharmacology at the University of Toronto, and head of the university’s mood disorders psychopharmacology unit, said that “there are implications not only for clinical outcomes and cost, but also implementation because IV is obviously more demanding and complicated.”

As intravenous ketamine increasingly gained interest as a rapid-acting treatment for patients with severe, treatment-resistant depression, the introduction of a more convenient intranasal formulation was seen as a welcome improvement and received approval from the Food and Drug Administration in 2019. However, while the approval ushered in more coverage by insurance companies, the treatment can still be expensive. Intravenous ketamine does not have FDA approval.

With a lack of studies in the real-world setting comparing efficacy of the two formulations, Dr. Singh and his colleagues conducted the observational study, evaluating the responses of 62 adults with treatment-resistant depression who had received either up to six IV ketamine infusions of 0.5 mg/kg, infused over 40 minutes, or up to eight intranasal esketamine treatments of 56/84 mg, as approved by the FDA, at the Mayo Clinic Depression Center.

Of the patients, who had a mean age of 47 years, 59 had major depression and 3 had bipolar depression. Among them, 76% (47) received intravenous ketamine and 24% (15) received esketamine, which Dr. Singh noted reflected the higher number of patients included before esketamine received FDA approval. The patients had similar comorbidity profiles, with the intravenous ketamine group having a higher body mass index at baseline.

Overall, the patients all had significant improvement in their depression at the end of the acute phase of 4 weeks, with a mean change in on the 16-Item Quick Inventory of Depressive Symptomatology (QIDS-SR) scale of –8.6 from baseline (P < .001).

The overall remission rate was 38.7% and overall response rate was 58.1%. Those receiving intravenous ketamine had response and remission rates of 57.4% and 42.6%, versus response and remission rates of 60.0% and 26.7% among the esketamine group, which Dr. Singh said were not significant differences (P > .05).

However, the mean number of treatments necessary to achieve response in the intravenous ketamine group was just 2.3 versus 4.6 with esketamine, and the mean number of treatments to achieve remission were 2.5 versus 6.3, respectively (P = .008).

After a multivariate adjustment, the time to response was determined to be faster with intravenous ketamine versus esketamine (hazard ratio, 2.61; P = .05) and the time to remission was also faster (HR, 5.0; P = .02).

“What this means is you would need fewer treatments to achieve a response or remission with IV ketamine, so there could be an acceleration of patients’ antidepressant response,” Dr. Singh explained.

There were no significant differences between the groups in terms of side effects, and most patients tolerated the treatments well.

Dr. Singh noted the limitation of the study is that it was observational and included a small sample size. Nevertheless, when asked which he would choose if starting treatment when insurance was not an issue, Dr. Singh replied: “I would take patient preference into account, but certainly IV seems to have an advantage.”

Dr. Roger S. McIntyre, University of Toronto
Dr. Roger S. McIntyre

Dr. McIntyre noted that, though small, the study’s setting in a real world clinical environment is important.

“Obviously this is observational and not controlled, but the strength is that this involved a real-world cohort of patients and real world applications,” he said. “It’s difficult to have a true comparator head-to-head trial, so that makes this all the more important because it takes into consideration all of the complexities of real world patients.”

Dr. McIntyre emphasized that the study is not “the last word on the story because we need to see a larger sample and replication. But certainly they make an argument that IV ketamine may have an advantage over the speed of onset with intranasal ketamine, which will need to be either replicated or refuted, but it’s a great starting point in the conversation.”
 

 

 

Navigating patient preference

Robert Meisner, MD, founding medical director of the McLean Ketamine Service, Division of Psychiatric Neurotherapeutics, McLean Hospital, Harvard Medical School, in Boston, noted that wide-ranging factors may influence patient as well as clinician decisions about which ketamine treatment approach to use.

“When a patient appears to be equally well-suited for both interventions, I continue to be surprised by why one patient will indicate a preference for intranasal esketamine, while another will lean toward IV racemic ketamine,” he said in an interview.

“Some patients find esketamine’s clear and consistent protocol optimal for scheduling and navigating the logistics of daily life; others value the flexibility offered by certain evidence-based, racemic (IV) protocols,” he said. “Predicting who will prefer each treatment, even with the apparent temporal advantage with IV ketamine, is extremely difficult.”

Likewise, in terms of clinician preference, Dr. Meisner notes that key concerns may sway decisions.

“If I’m concerned with labile pressures or hypertension, for example, or if I have a patient with, say, Erlos Danlos Syndrome without a clear subtype, and hence, some risk of undiscovered aneurysmal vascular disease, I may lean toward racemic IV ketamine.”

On the other hand, “some patients find the simplicity and predictability of the maintenance esketamine protocol comforting and psychologically stabilizing,” he added. “Yet others find that their work or family’s erratic demands on their time make one of the evidence-based racemic regimens preferable – inasmuch as it integrates more flexibility and allows them to remain more fully engaged in the basic activities or work and family.”

Dr. Meisner noted the caveat that efforts to decide which method to use are often complicated by substantial misinformation.

“I can’t emphasize how much misinformation continues to abound regarding appropriate (evidence-based) and safe use of ketamine and esketamine,” he said. “Especially on the IV racemic side, there simply is no substantive evidence base for many of the claims that some providers are preaching.”

The confusion, driven in part by social media, “has diffused into sectors of the field and industry that one might assume are relatively immune (i.e., allied physicians, sophisticated payers, etc),” he added.

“In short, two mantra continue to apply,” Dr. Meisner said. “One – if it sounds too good to be true, it probably is; and two – in pharmacology and interventional psychiatry, we see remarkable progress and potential, but there simply is no such thing as a magic bullet.”

Dr. Singh and Dr. Meisner had no disclosures to report. Dr. McIntyre has received research grant support from Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/National Natural Science Foundation of China, and speaker/consultation fees from Lundbeck, Janssen, Alkermes,Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Abbvie, and Atai Life Sciences. Dr. McIntyre is a CEO of Braxia Scientific.

NEW ORLEANS – New research reveals that patients with treatment-resistant depression who were treated with repeated intravenous ketamine show no significant differences in achieving response or remission, compared with those receiving the intranasal formulation of the drug, esketamine – although fewer treatments appear necessary with the intravenous formulation.

This is one of the first studies to compare the efficacy of IV and intranasal ketamine, and the results give us some indication that, if you treat with IV, you might get a faster response, although at the end, the responses are similar,” said first author Balwinder Singh, MD, of the department of psychiatry and psychology, Mayo Clinic, in Rochester, Minn.

Dr. Balwinder Singh, Department of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota
courtesy Balwinder Singh
Dr. Balwinder Singh

The findings were presented at the annual meeting of the American Psychiatric Association.

Commenting on the study, Roger S. McIntyre, MD, underscored that “this is an important study that addresses the priority questions that everyone wants to know – not only for clinical reasons, but economic reasons.” Dr. McIntyre, a professor of psychiatry and pharmacology at the University of Toronto, and head of the university’s mood disorders psychopharmacology unit, said that “there are implications not only for clinical outcomes and cost, but also implementation because IV is obviously more demanding and complicated.”

As intravenous ketamine increasingly gained interest as a rapid-acting treatment for patients with severe, treatment-resistant depression, the introduction of a more convenient intranasal formulation was seen as a welcome improvement and received approval from the Food and Drug Administration in 2019. However, while the approval ushered in more coverage by insurance companies, the treatment can still be expensive. Intravenous ketamine does not have FDA approval.

With a lack of studies in the real-world setting comparing efficacy of the two formulations, Dr. Singh and his colleagues conducted the observational study, evaluating the responses of 62 adults with treatment-resistant depression who had received either up to six IV ketamine infusions of 0.5 mg/kg, infused over 40 minutes, or up to eight intranasal esketamine treatments of 56/84 mg, as approved by the FDA, at the Mayo Clinic Depression Center.

Of the patients, who had a mean age of 47 years, 59 had major depression and 3 had bipolar depression. Among them, 76% (47) received intravenous ketamine and 24% (15) received esketamine, which Dr. Singh noted reflected the higher number of patients included before esketamine received FDA approval. The patients had similar comorbidity profiles, with the intravenous ketamine group having a higher body mass index at baseline.

Overall, the patients all had significant improvement in their depression at the end of the acute phase of 4 weeks, with a mean change in on the 16-Item Quick Inventory of Depressive Symptomatology (QIDS-SR) scale of –8.6 from baseline (P < .001).

The overall remission rate was 38.7% and overall response rate was 58.1%. Those receiving intravenous ketamine had response and remission rates of 57.4% and 42.6%, versus response and remission rates of 60.0% and 26.7% among the esketamine group, which Dr. Singh said were not significant differences (P > .05).

However, the mean number of treatments necessary to achieve response in the intravenous ketamine group was just 2.3 versus 4.6 with esketamine, and the mean number of treatments to achieve remission were 2.5 versus 6.3, respectively (P = .008).

After a multivariate adjustment, the time to response was determined to be faster with intravenous ketamine versus esketamine (hazard ratio, 2.61; P = .05) and the time to remission was also faster (HR, 5.0; P = .02).

“What this means is you would need fewer treatments to achieve a response or remission with IV ketamine, so there could be an acceleration of patients’ antidepressant response,” Dr. Singh explained.

There were no significant differences between the groups in terms of side effects, and most patients tolerated the treatments well.

Dr. Singh noted the limitation of the study is that it was observational and included a small sample size. Nevertheless, when asked which he would choose if starting treatment when insurance was not an issue, Dr. Singh replied: “I would take patient preference into account, but certainly IV seems to have an advantage.”

Dr. Roger S. McIntyre, University of Toronto
Dr. Roger S. McIntyre

Dr. McIntyre noted that, though small, the study’s setting in a real world clinical environment is important.

“Obviously this is observational and not controlled, but the strength is that this involved a real-world cohort of patients and real world applications,” he said. “It’s difficult to have a true comparator head-to-head trial, so that makes this all the more important because it takes into consideration all of the complexities of real world patients.”

Dr. McIntyre emphasized that the study is not “the last word on the story because we need to see a larger sample and replication. But certainly they make an argument that IV ketamine may have an advantage over the speed of onset with intranasal ketamine, which will need to be either replicated or refuted, but it’s a great starting point in the conversation.”
 

 

 

Navigating patient preference

Robert Meisner, MD, founding medical director of the McLean Ketamine Service, Division of Psychiatric Neurotherapeutics, McLean Hospital, Harvard Medical School, in Boston, noted that wide-ranging factors may influence patient as well as clinician decisions about which ketamine treatment approach to use.

“When a patient appears to be equally well-suited for both interventions, I continue to be surprised by why one patient will indicate a preference for intranasal esketamine, while another will lean toward IV racemic ketamine,” he said in an interview.

“Some patients find esketamine’s clear and consistent protocol optimal for scheduling and navigating the logistics of daily life; others value the flexibility offered by certain evidence-based, racemic (IV) protocols,” he said. “Predicting who will prefer each treatment, even with the apparent temporal advantage with IV ketamine, is extremely difficult.”

Likewise, in terms of clinician preference, Dr. Meisner notes that key concerns may sway decisions.

“If I’m concerned with labile pressures or hypertension, for example, or if I have a patient with, say, Erlos Danlos Syndrome without a clear subtype, and hence, some risk of undiscovered aneurysmal vascular disease, I may lean toward racemic IV ketamine.”

On the other hand, “some patients find the simplicity and predictability of the maintenance esketamine protocol comforting and psychologically stabilizing,” he added. “Yet others find that their work or family’s erratic demands on their time make one of the evidence-based racemic regimens preferable – inasmuch as it integrates more flexibility and allows them to remain more fully engaged in the basic activities or work and family.”

Dr. Meisner noted the caveat that efforts to decide which method to use are often complicated by substantial misinformation.

“I can’t emphasize how much misinformation continues to abound regarding appropriate (evidence-based) and safe use of ketamine and esketamine,” he said. “Especially on the IV racemic side, there simply is no substantive evidence base for many of the claims that some providers are preaching.”

The confusion, driven in part by social media, “has diffused into sectors of the field and industry that one might assume are relatively immune (i.e., allied physicians, sophisticated payers, etc),” he added.

“In short, two mantra continue to apply,” Dr. Meisner said. “One – if it sounds too good to be true, it probably is; and two – in pharmacology and interventional psychiatry, we see remarkable progress and potential, but there simply is no such thing as a magic bullet.”

Dr. Singh and Dr. Meisner had no disclosures to report. Dr. McIntyre has received research grant support from Canadian Institutes of Health Research/Global Alliance for Chronic Diseases/National Natural Science Foundation of China, and speaker/consultation fees from Lundbeck, Janssen, Alkermes,Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Abbvie, and Atai Life Sciences. Dr. McIntyre is a CEO of Braxia Scientific.

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Lithium lowers osteoporosis risk in bipolar patients…and orthopedists take notice

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People with bipolar disorder – particularly men – show a significantly increased risk of osteoporosis, compared with the general population, but treatment with lithium appears to offer a significant protective effect against the bone disease, according to results from the largest study of its kind.

“Our findings emphasize that bone health should be a priority in the clinical management of bipolar disorder, and that the potential bone-protective effects of lithium should be subjected to further study – both in the context of osteoporosis and bipolar disorder,” said Soren D. Ostergaard, MD, PhD, the study’s first author and a professor in the psychosis research unit, Aarhus (Denmark) University Hospital – Psychiatry.

Psychosis Research Unit, Aarhus University Hospital - Psychiatry, Aarhus, Denmark
courtesy Aarhus University
Dr. Soren D. Ostergaard

For the retrospective cohort study, presented at the annual meeting of the American Psychiatric Association, and also published recently in JAMA Psychiatry, the authors reviewed data on 22,912 patients treated for bipolar disorder in Denmark between 1996 and 2019, and compared each patient with 5 age- and sex-matched controls, amounting to 114,560 individuals in the general population.

Of the patients with bipolar disorder, 38.2% were treated with lithium, while 73.6% received an antipsychotic drug; 16.8% received valproate and 33.1% received lamotrigine.

With a median follow-up of 7.7 years, the incidence of osteoporosis per 1,000 person-years was 8.70 among patients with bipolar disorder, compared with an incidence of 7.84 among controls, (hazard rate ratio, 1.15).

The association of bipolar disorder with osteoporosis was notably more pronounced among males (HRR, 1.42) compared with females (HRR, 1.07).

Notably, those with bipolar disorder treated with lithium showed a significantly reduced risk of osteoporosis compared with patients not receiving lithium (HRR, 0.62), after adjustment for factors including age, sex, Charlson Comorbidity Index, use of systemic corticosteroids, use of sedative medication, and eating disorder diagnosis. No similar reductions in osteoporosis risk were observed among those treated with antipsychotics, valproate or lamotrigine.

Of note, the reduced risk of osteoporosis with lithium appeared after about year 2 of treatment (HR, 0.77) and remained steady at more than 4 years (HR, 0.76). A higher cumulative lithium dose was meanwhile associated with a greater decrease in the risk of osteoporosis (P < .001).
 

Results confirm prior research

The results are consistent with previous smaller studies indicating that people with bipolar disorders shown an increased risk of low bone density, osteopenia, and even fracture.

The higher risk of osteoporosis in bipolar disorder may be explained by lifestyle factors, Dr. Ostergaard noted in an interview.

“It could be the depressive and manic phases in bipolar disorder, but generally speaking, both phases can lead to an unhealthy lifestyle and that’s likely what drives the association between bipolar disorder and osteoporosis,” he said. “Increases in behaviors such as smoking and alcohol consumption may be factors as well. Similar findings are seen with depression.”

While more needs to be understood, Dr. Ostergaard speculated that higher rates of such behaviors in men with bipolar disorder may explain the higher osteoporosis risk observed in men.

In general, however, the increased risk underscores the importance of raising awareness of bone health among patients with bipolar disorder, the authors concluded.

“Specifically, guiding patients toward a lifestyle supporting bone health (no smoking, reduced alcohol consumption, healthy diet, and exercising) and monitoring bone density via dual-energy x-ray absorptiometry scans among those with additional risk factors seems warranted,” they wrote.

The implications of the lithium findings are trickier to determine, Dr. Ostergaard said.

“The evidence for lithium in bipolar disorder are well established, and our findings don’t really add to that,” he said. “The main thing is it suggests there might be some advantages of lithium that we’re not really aware of.”
 

 

 

Findings important for orthopedists

The unique properties observed with lithium have caught the attention of some in orthopedics, and researchers with the University of Toronto – having found intriguing bone healing with lithium in preclinical rodent studies – are currently conducting a first-of-its-kind multicenter, randomized, controlled clinical trial evaluating the potential effects of lithium in the healing of bone fractures.

Division of Orthopedic Surgery, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
courtesy Sunnybrook Health Sciences Centre
Dr. Diane Nam

Diane Nam, MD, of the division of orthopedic surgery, Sunnybrook Health Sciences Centre, Toronto, and lead investigator on the study, said in an interview that “I’m not surprised by [Dr. Ostergaard’s] paper because it’s consistent with what we have observed about the positive effects on bone healing.”

Dr. Nam and associates have already established administration parameters for their clinical study, determining that optimal effects in fracture healing appear to require that lithium treatment not begin at the time of fracture, but 2 weeks afterward, when new bone is ready to be laid down at the fracture site. In their trial, low daily doses of lithium (at 300 mg) are given only for a duration of 2 weeks.

“While our current trial is intended for a healthy, nonosteoporotic adult population, we have also demonstrated in our preclinical studies that lithium is just as effective in improving fracture healing in an osteoporotic model when the timing of administration is slightly delayed,” she said. “How this is relevant and translatable in patients with bipolar disorder requires further study.”

Dr. Nam said her research team thinks that “not only will the fracture heal faster, but it will heal reliably as delayed or impaired fracture healing remains a significant orthopedic problem.”

While details are not yet available, a preliminary analysis has shown results “going in a positive direction,” enough for the team to be granted funding for the multicenter trial.

Dr. Ostergaard and Dr. Nam reported no disclosures or conflicts.

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People with bipolar disorder – particularly men – show a significantly increased risk of osteoporosis, compared with the general population, but treatment with lithium appears to offer a significant protective effect against the bone disease, according to results from the largest study of its kind.

“Our findings emphasize that bone health should be a priority in the clinical management of bipolar disorder, and that the potential bone-protective effects of lithium should be subjected to further study – both in the context of osteoporosis and bipolar disorder,” said Soren D. Ostergaard, MD, PhD, the study’s first author and a professor in the psychosis research unit, Aarhus (Denmark) University Hospital – Psychiatry.

Psychosis Research Unit, Aarhus University Hospital - Psychiatry, Aarhus, Denmark
courtesy Aarhus University
Dr. Soren D. Ostergaard

For the retrospective cohort study, presented at the annual meeting of the American Psychiatric Association, and also published recently in JAMA Psychiatry, the authors reviewed data on 22,912 patients treated for bipolar disorder in Denmark between 1996 and 2019, and compared each patient with 5 age- and sex-matched controls, amounting to 114,560 individuals in the general population.

Of the patients with bipolar disorder, 38.2% were treated with lithium, while 73.6% received an antipsychotic drug; 16.8% received valproate and 33.1% received lamotrigine.

With a median follow-up of 7.7 years, the incidence of osteoporosis per 1,000 person-years was 8.70 among patients with bipolar disorder, compared with an incidence of 7.84 among controls, (hazard rate ratio, 1.15).

The association of bipolar disorder with osteoporosis was notably more pronounced among males (HRR, 1.42) compared with females (HRR, 1.07).

Notably, those with bipolar disorder treated with lithium showed a significantly reduced risk of osteoporosis compared with patients not receiving lithium (HRR, 0.62), after adjustment for factors including age, sex, Charlson Comorbidity Index, use of systemic corticosteroids, use of sedative medication, and eating disorder diagnosis. No similar reductions in osteoporosis risk were observed among those treated with antipsychotics, valproate or lamotrigine.

Of note, the reduced risk of osteoporosis with lithium appeared after about year 2 of treatment (HR, 0.77) and remained steady at more than 4 years (HR, 0.76). A higher cumulative lithium dose was meanwhile associated with a greater decrease in the risk of osteoporosis (P < .001).
 

Results confirm prior research

The results are consistent with previous smaller studies indicating that people with bipolar disorders shown an increased risk of low bone density, osteopenia, and even fracture.

The higher risk of osteoporosis in bipolar disorder may be explained by lifestyle factors, Dr. Ostergaard noted in an interview.

“It could be the depressive and manic phases in bipolar disorder, but generally speaking, both phases can lead to an unhealthy lifestyle and that’s likely what drives the association between bipolar disorder and osteoporosis,” he said. “Increases in behaviors such as smoking and alcohol consumption may be factors as well. Similar findings are seen with depression.”

While more needs to be understood, Dr. Ostergaard speculated that higher rates of such behaviors in men with bipolar disorder may explain the higher osteoporosis risk observed in men.

In general, however, the increased risk underscores the importance of raising awareness of bone health among patients with bipolar disorder, the authors concluded.

“Specifically, guiding patients toward a lifestyle supporting bone health (no smoking, reduced alcohol consumption, healthy diet, and exercising) and monitoring bone density via dual-energy x-ray absorptiometry scans among those with additional risk factors seems warranted,” they wrote.

The implications of the lithium findings are trickier to determine, Dr. Ostergaard said.

“The evidence for lithium in bipolar disorder are well established, and our findings don’t really add to that,” he said. “The main thing is it suggests there might be some advantages of lithium that we’re not really aware of.”
 

 

 

Findings important for orthopedists

The unique properties observed with lithium have caught the attention of some in orthopedics, and researchers with the University of Toronto – having found intriguing bone healing with lithium in preclinical rodent studies – are currently conducting a first-of-its-kind multicenter, randomized, controlled clinical trial evaluating the potential effects of lithium in the healing of bone fractures.

Division of Orthopedic Surgery, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
courtesy Sunnybrook Health Sciences Centre
Dr. Diane Nam

Diane Nam, MD, of the division of orthopedic surgery, Sunnybrook Health Sciences Centre, Toronto, and lead investigator on the study, said in an interview that “I’m not surprised by [Dr. Ostergaard’s] paper because it’s consistent with what we have observed about the positive effects on bone healing.”

Dr. Nam and associates have already established administration parameters for their clinical study, determining that optimal effects in fracture healing appear to require that lithium treatment not begin at the time of fracture, but 2 weeks afterward, when new bone is ready to be laid down at the fracture site. In their trial, low daily doses of lithium (at 300 mg) are given only for a duration of 2 weeks.

“While our current trial is intended for a healthy, nonosteoporotic adult population, we have also demonstrated in our preclinical studies that lithium is just as effective in improving fracture healing in an osteoporotic model when the timing of administration is slightly delayed,” she said. “How this is relevant and translatable in patients with bipolar disorder requires further study.”

Dr. Nam said her research team thinks that “not only will the fracture heal faster, but it will heal reliably as delayed or impaired fracture healing remains a significant orthopedic problem.”

While details are not yet available, a preliminary analysis has shown results “going in a positive direction,” enough for the team to be granted funding for the multicenter trial.

Dr. Ostergaard and Dr. Nam reported no disclosures or conflicts.

People with bipolar disorder – particularly men – show a significantly increased risk of osteoporosis, compared with the general population, but treatment with lithium appears to offer a significant protective effect against the bone disease, according to results from the largest study of its kind.

“Our findings emphasize that bone health should be a priority in the clinical management of bipolar disorder, and that the potential bone-protective effects of lithium should be subjected to further study – both in the context of osteoporosis and bipolar disorder,” said Soren D. Ostergaard, MD, PhD, the study’s first author and a professor in the psychosis research unit, Aarhus (Denmark) University Hospital – Psychiatry.

Psychosis Research Unit, Aarhus University Hospital - Psychiatry, Aarhus, Denmark
courtesy Aarhus University
Dr. Soren D. Ostergaard

For the retrospective cohort study, presented at the annual meeting of the American Psychiatric Association, and also published recently in JAMA Psychiatry, the authors reviewed data on 22,912 patients treated for bipolar disorder in Denmark between 1996 and 2019, and compared each patient with 5 age- and sex-matched controls, amounting to 114,560 individuals in the general population.

Of the patients with bipolar disorder, 38.2% were treated with lithium, while 73.6% received an antipsychotic drug; 16.8% received valproate and 33.1% received lamotrigine.

With a median follow-up of 7.7 years, the incidence of osteoporosis per 1,000 person-years was 8.70 among patients with bipolar disorder, compared with an incidence of 7.84 among controls, (hazard rate ratio, 1.15).

The association of bipolar disorder with osteoporosis was notably more pronounced among males (HRR, 1.42) compared with females (HRR, 1.07).

Notably, those with bipolar disorder treated with lithium showed a significantly reduced risk of osteoporosis compared with patients not receiving lithium (HRR, 0.62), after adjustment for factors including age, sex, Charlson Comorbidity Index, use of systemic corticosteroids, use of sedative medication, and eating disorder diagnosis. No similar reductions in osteoporosis risk were observed among those treated with antipsychotics, valproate or lamotrigine.

Of note, the reduced risk of osteoporosis with lithium appeared after about year 2 of treatment (HR, 0.77) and remained steady at more than 4 years (HR, 0.76). A higher cumulative lithium dose was meanwhile associated with a greater decrease in the risk of osteoporosis (P < .001).
 

Results confirm prior research

The results are consistent with previous smaller studies indicating that people with bipolar disorders shown an increased risk of low bone density, osteopenia, and even fracture.

The higher risk of osteoporosis in bipolar disorder may be explained by lifestyle factors, Dr. Ostergaard noted in an interview.

“It could be the depressive and manic phases in bipolar disorder, but generally speaking, both phases can lead to an unhealthy lifestyle and that’s likely what drives the association between bipolar disorder and osteoporosis,” he said. “Increases in behaviors such as smoking and alcohol consumption may be factors as well. Similar findings are seen with depression.”

While more needs to be understood, Dr. Ostergaard speculated that higher rates of such behaviors in men with bipolar disorder may explain the higher osteoporosis risk observed in men.

In general, however, the increased risk underscores the importance of raising awareness of bone health among patients with bipolar disorder, the authors concluded.

“Specifically, guiding patients toward a lifestyle supporting bone health (no smoking, reduced alcohol consumption, healthy diet, and exercising) and monitoring bone density via dual-energy x-ray absorptiometry scans among those with additional risk factors seems warranted,” they wrote.

The implications of the lithium findings are trickier to determine, Dr. Ostergaard said.

“The evidence for lithium in bipolar disorder are well established, and our findings don’t really add to that,” he said. “The main thing is it suggests there might be some advantages of lithium that we’re not really aware of.”
 

 

 

Findings important for orthopedists

The unique properties observed with lithium have caught the attention of some in orthopedics, and researchers with the University of Toronto – having found intriguing bone healing with lithium in preclinical rodent studies – are currently conducting a first-of-its-kind multicenter, randomized, controlled clinical trial evaluating the potential effects of lithium in the healing of bone fractures.

Division of Orthopedic Surgery, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
courtesy Sunnybrook Health Sciences Centre
Dr. Diane Nam

Diane Nam, MD, of the division of orthopedic surgery, Sunnybrook Health Sciences Centre, Toronto, and lead investigator on the study, said in an interview that “I’m not surprised by [Dr. Ostergaard’s] paper because it’s consistent with what we have observed about the positive effects on bone healing.”

Dr. Nam and associates have already established administration parameters for their clinical study, determining that optimal effects in fracture healing appear to require that lithium treatment not begin at the time of fracture, but 2 weeks afterward, when new bone is ready to be laid down at the fracture site. In their trial, low daily doses of lithium (at 300 mg) are given only for a duration of 2 weeks.

“While our current trial is intended for a healthy, nonosteoporotic adult population, we have also demonstrated in our preclinical studies that lithium is just as effective in improving fracture healing in an osteoporotic model when the timing of administration is slightly delayed,” she said. “How this is relevant and translatable in patients with bipolar disorder requires further study.”

Dr. Nam said her research team thinks that “not only will the fracture heal faster, but it will heal reliably as delayed or impaired fracture healing remains a significant orthopedic problem.”

While details are not yet available, a preliminary analysis has shown results “going in a positive direction,” enough for the team to be granted funding for the multicenter trial.

Dr. Ostergaard and Dr. Nam reported no disclosures or conflicts.

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APA targets structural racism, offers solutions

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The negative consequences of structural racism on mental health, and opportunities for change, are the focus of a special issue of the American Journal of Psychiatryreleased to coincide with the annual meeting of the American Psychiatric Association.

The hope is this special issue will “motivate clinicians, educators, and researchers to take actions that will make a difference,” Ned H. Kalin, MD, AJP editor-in-chief, wrotes in an editor’s note

“We cannot overestimate the impact of structural racism from the standpoint of its consequences related to mental health issues and mental health care,” Dr. Kalin said during an APA press briefing.

“This is one of our highest priorities, if not our highest priority,” he noted. The journal is the “voice of American and international psychiatry” and is a “great vehicle” for moving the field forward, he added.

Articles in the issue highlight “new directions to understand and eliminate mental health disparities [through a] multidimensional lens,” wrote Crystal L. Barksdale, PhD, health scientist administrator and program director with the National Institute on Minority Health and Health Disparities. Dr. Barksdale was guest editor for the issue.
 

A new agenda for change

In one article, Margarita Alegría, PhD, chief of the disparities research unit at Massachusetts General Hospital, Boston, and colleagues, wrote that the Biden Administration’s new budget offers the opportunity to redesign mental health research and service delivery in marginalized communities.

Given the rising mental health crisis in the U.S., the FY22 budget includes $1.6 billion for the community mental health services block grant program, which is more than double the money allocated in FY21.

Dr. Alegría and colleagues describe several interventions that have “sound evidence” of improving mental health or related outcomes among people of color in the U.S. within 5 years – by addressing social determinants of health.

They include universal school meal programs, community-based interventions delivered by paraprofessionals in after-school recreational programs, individual placement and support for employment, mental health literacy programs, senior centers offering health promotion activities, and a chronic disease self-management program.

Dr. Alegría noted that reducing structural racism and mental health disparities requires multilevel structural solutions and action by multiple stakeholders. In essence, “it takes a village,” she said.
 

A national conversation

Another article highlighted at the press briefing focuses on structural racism as it relates to youth suicide prevention.

Studies have shown the risk for suicide is higher earlier in life for youth of color. Suicide rates peak in adolescence and young adulthood for youth of color; for White populations, the peak happens in middle age and later life, noted lead author Kiara Alvarez, PhD, research scientist with Mass General’s disparities research unit.

However, there are well documented mental health service disparities where youth of color experiencing suicidal thoughts and behaviors have lower rates of access to needed services. They also have delays in access compared with their White peers, Dr. Alvarez said.

The authors propose a framework to address structural racism and mental health disparities as it relates to youth suicide prevention, with a focus on systems that are “preventive, rather than reactive; restorative, rather than punitive; and community-driven, rather than externally imposed.

“Ultimately, only structural solutions can dismantle structural racism,” they wrote.

The special issue of AJP aligns with the theme of this year’s APA meeting, which is the social determinants of mental health.

“Mental health has clearly become part of the national conversation. This has given us the opportunity to discuss how factors outside of the office and hospitals can impact the lives of many with mental illness and substance use disorder,” APA President Vivian B. Pender, MD, said during a preconference press briefing. 

“These factors may include where you live, the air you breathe, how you’re educated, exposure to violence, and the impact of racism. These social determinants have become especially relevant to good mental health,” Dr. Pender said.

The research was supported by grants from the National Institute of Mental Health, the National Institute on Minority Health and Health Disparities, the National Institute of Drug Abuse, the National Institute of Alcohol Abuse and Alcoholism, and the National Institute of Child Health and Human Development. Dr. Kalin, Dr. Barksdale, Dr. Alegría, Dr. Alvarez, and Dr. Pender have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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The negative consequences of structural racism on mental health, and opportunities for change, are the focus of a special issue of the American Journal of Psychiatryreleased to coincide with the annual meeting of the American Psychiatric Association.

The hope is this special issue will “motivate clinicians, educators, and researchers to take actions that will make a difference,” Ned H. Kalin, MD, AJP editor-in-chief, wrotes in an editor’s note

“We cannot overestimate the impact of structural racism from the standpoint of its consequences related to mental health issues and mental health care,” Dr. Kalin said during an APA press briefing.

“This is one of our highest priorities, if not our highest priority,” he noted. The journal is the “voice of American and international psychiatry” and is a “great vehicle” for moving the field forward, he added.

Articles in the issue highlight “new directions to understand and eliminate mental health disparities [through a] multidimensional lens,” wrote Crystal L. Barksdale, PhD, health scientist administrator and program director with the National Institute on Minority Health and Health Disparities. Dr. Barksdale was guest editor for the issue.
 

A new agenda for change

In one article, Margarita Alegría, PhD, chief of the disparities research unit at Massachusetts General Hospital, Boston, and colleagues, wrote that the Biden Administration’s new budget offers the opportunity to redesign mental health research and service delivery in marginalized communities.

Given the rising mental health crisis in the U.S., the FY22 budget includes $1.6 billion for the community mental health services block grant program, which is more than double the money allocated in FY21.

Dr. Alegría and colleagues describe several interventions that have “sound evidence” of improving mental health or related outcomes among people of color in the U.S. within 5 years – by addressing social determinants of health.

They include universal school meal programs, community-based interventions delivered by paraprofessionals in after-school recreational programs, individual placement and support for employment, mental health literacy programs, senior centers offering health promotion activities, and a chronic disease self-management program.

Dr. Alegría noted that reducing structural racism and mental health disparities requires multilevel structural solutions and action by multiple stakeholders. In essence, “it takes a village,” she said.
 

A national conversation

Another article highlighted at the press briefing focuses on structural racism as it relates to youth suicide prevention.

Studies have shown the risk for suicide is higher earlier in life for youth of color. Suicide rates peak in adolescence and young adulthood for youth of color; for White populations, the peak happens in middle age and later life, noted lead author Kiara Alvarez, PhD, research scientist with Mass General’s disparities research unit.

However, there are well documented mental health service disparities where youth of color experiencing suicidal thoughts and behaviors have lower rates of access to needed services. They also have delays in access compared with their White peers, Dr. Alvarez said.

The authors propose a framework to address structural racism and mental health disparities as it relates to youth suicide prevention, with a focus on systems that are “preventive, rather than reactive; restorative, rather than punitive; and community-driven, rather than externally imposed.

“Ultimately, only structural solutions can dismantle structural racism,” they wrote.

The special issue of AJP aligns with the theme of this year’s APA meeting, which is the social determinants of mental health.

“Mental health has clearly become part of the national conversation. This has given us the opportunity to discuss how factors outside of the office and hospitals can impact the lives of many with mental illness and substance use disorder,” APA President Vivian B. Pender, MD, said during a preconference press briefing. 

“These factors may include where you live, the air you breathe, how you’re educated, exposure to violence, and the impact of racism. These social determinants have become especially relevant to good mental health,” Dr. Pender said.

The research was supported by grants from the National Institute of Mental Health, the National Institute on Minority Health and Health Disparities, the National Institute of Drug Abuse, the National Institute of Alcohol Abuse and Alcoholism, and the National Institute of Child Health and Human Development. Dr. Kalin, Dr. Barksdale, Dr. Alegría, Dr. Alvarez, and Dr. Pender have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The negative consequences of structural racism on mental health, and opportunities for change, are the focus of a special issue of the American Journal of Psychiatryreleased to coincide with the annual meeting of the American Psychiatric Association.

The hope is this special issue will “motivate clinicians, educators, and researchers to take actions that will make a difference,” Ned H. Kalin, MD, AJP editor-in-chief, wrotes in an editor’s note

“We cannot overestimate the impact of structural racism from the standpoint of its consequences related to mental health issues and mental health care,” Dr. Kalin said during an APA press briefing.

“This is one of our highest priorities, if not our highest priority,” he noted. The journal is the “voice of American and international psychiatry” and is a “great vehicle” for moving the field forward, he added.

Articles in the issue highlight “new directions to understand and eliminate mental health disparities [through a] multidimensional lens,” wrote Crystal L. Barksdale, PhD, health scientist administrator and program director with the National Institute on Minority Health and Health Disparities. Dr. Barksdale was guest editor for the issue.
 

A new agenda for change

In one article, Margarita Alegría, PhD, chief of the disparities research unit at Massachusetts General Hospital, Boston, and colleagues, wrote that the Biden Administration’s new budget offers the opportunity to redesign mental health research and service delivery in marginalized communities.

Given the rising mental health crisis in the U.S., the FY22 budget includes $1.6 billion for the community mental health services block grant program, which is more than double the money allocated in FY21.

Dr. Alegría and colleagues describe several interventions that have “sound evidence” of improving mental health or related outcomes among people of color in the U.S. within 5 years – by addressing social determinants of health.

They include universal school meal programs, community-based interventions delivered by paraprofessionals in after-school recreational programs, individual placement and support for employment, mental health literacy programs, senior centers offering health promotion activities, and a chronic disease self-management program.

Dr. Alegría noted that reducing structural racism and mental health disparities requires multilevel structural solutions and action by multiple stakeholders. In essence, “it takes a village,” she said.
 

A national conversation

Another article highlighted at the press briefing focuses on structural racism as it relates to youth suicide prevention.

Studies have shown the risk for suicide is higher earlier in life for youth of color. Suicide rates peak in adolescence and young adulthood for youth of color; for White populations, the peak happens in middle age and later life, noted lead author Kiara Alvarez, PhD, research scientist with Mass General’s disparities research unit.

However, there are well documented mental health service disparities where youth of color experiencing suicidal thoughts and behaviors have lower rates of access to needed services. They also have delays in access compared with their White peers, Dr. Alvarez said.

The authors propose a framework to address structural racism and mental health disparities as it relates to youth suicide prevention, with a focus on systems that are “preventive, rather than reactive; restorative, rather than punitive; and community-driven, rather than externally imposed.

“Ultimately, only structural solutions can dismantle structural racism,” they wrote.

The special issue of AJP aligns with the theme of this year’s APA meeting, which is the social determinants of mental health.

“Mental health has clearly become part of the national conversation. This has given us the opportunity to discuss how factors outside of the office and hospitals can impact the lives of many with mental illness and substance use disorder,” APA President Vivian B. Pender, MD, said during a preconference press briefing. 

“These factors may include where you live, the air you breathe, how you’re educated, exposure to violence, and the impact of racism. These social determinants have become especially relevant to good mental health,” Dr. Pender said.

The research was supported by grants from the National Institute of Mental Health, the National Institute on Minority Health and Health Disparities, the National Institute of Drug Abuse, the National Institute of Alcohol Abuse and Alcoholism, and the National Institute of Child Health and Human Development. Dr. Kalin, Dr. Barksdale, Dr. Alegría, Dr. Alvarez, and Dr. Pender have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Disasters abroad a major trigger for mental illness in expats

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The 2020 explosion that rocked Beirut, killing more than 200, injuring more than 7,000 and causing millions of dollars in damage had a significant impact on the mental health of Lebanese expatriates, leaving many grappling with anxiety, depression, and posttraumatic stress disorder, results of a new survey show.

The findings highlight the importance of considering the well-being of expatriates dealing with adverse events in their home countries, the investigators say.

research postdoctoral fellow, Northwestern University, Chicago
Dr. Gaëlle Rached
Dr. Gaëlle Rached

“Everyone, including doctors, should be more sensitive to expatriates around them; we should look out for them especially when their home country is going through a traumatic event,” study investigator Gaëlle Rached, MD, MSc, research postdoctoral fellow, Northwestern University, Chicago, told this news organization.

The findings were presented at the annual meeting of the American Psychiatric Association.
 

A historic explosion

It is estimated that approximately 14 million Lebanese citizens live outside their home country, which is more than double the population of Lebanon. However, the trauma-related mental health of these and other expatriate communities is understudied, said Dr. Rached.

“If you look at the literature, next to no one has examined expatriates’ mental health, and more so in the context of trauma.”

Dr. Rached has personal experience with the event. She was in Beirut on Aug. 4, 2020, when the Lebanese capital was rocked by an explosion attributed to ammonium nitrate stored at the city’s port. It was one of the biggest nonnuclear explosions in history and left hundreds homeless, killed, or injured. Dr. Rached watched as her father was injured and her house destroyed.

She heard anecdotes of Lebanese expatriates, experiencing trauma as a result of the blast. Many were unable to contact friends and loved ones in the wake of the tragedy.

“That prompted us to look at expatriate mental health following this traumatic incident,” she said.

She and her colleagues used various social media platforms to advertise the survey. They also reached out to the International Lebanese Medical Association, which has “a strong base” in the United States, said Dr. Rached.

She was “shocked” at how many expatriates responded. “People really wanted to speak up and express themselves” – whether because of survivor’s guilt or for some other reason, she said.

The survey included 670 adults with Lebanese nationality or who were first generation Lebanese living abroad. The study population had a median age 31 years and 62.2% female, most living in North America or Europe. Over one-third of respondents (270) had been living abroad from 1-5 years but many had been away for more than 20 years.

Study participants completed the Hopkins Symptoms Checklist (HSCL), which screens for anxiety and depression. On this checklist, a score of 1.75 is a typical cutoff value for symptomatic cases.

The investigators found 41.2% of participants scored higher than this threshold. Being younger, female and visiting Lebanon at the time of the blast, were factors associated with higher HSCL scores.
 

No tincture of time

Interestingly, the amount of time since emigrating from Lebanon was unrelated to the score. “Our results show that, no matter how long you’ve been away, you’re prone to the same negative outcome,” said Dr. Rached.

Of the total study population, 268 personally experienced the explosion and/or had close friends or family physically affected by it. These expatriates completed the Post-traumatic Checklist for DSM-5 (PCL-5).

Here, the analysis showed that many of these respondents (57.5%) scored above 33, which is higher than the threshold for probable PTSD. Being female was linked to higher PCL-5 scores.

These findings suggest the mental health of expatriates may be negatively affected by traumatic incidents in their home countries, even if they didn’t witness the event firsthand and have been away from their home country for a long time.

The results may be especially timely as many countries are taking in a flood of refugees fleeing war in Ukraine. However, Dr. Rached said, the findings from her research may not apply to Ukrainians.

“I don’t think the results can be extrapolated, given that the nature of the trauma is a little bit different,” she said, adding that the Beirut blast was “monumental” but it was over quickly. In contrast, there’s no end in sight for the Russian invasion of Ukraine.

Dr. Rached noted the study data are preliminary and limited because there’s no way to determine whether respondents had mental health issues before the blast.
 

Global psychiatrist shortage

Commenting on the study, Howard Liu, MD, chair of the University of Nebraska Medical Center department of psychiatry in Omaha, and incoming chair of the APA’s Council on Communications, said he found the presentation “fascinating on several levels.”

Dr. Howard Liu, University of Nebraska, Omaha
Dr. Howard Liu

It’s increasingly important for psychiatrists to be “trauma informed,” Dr. Liu told a press briefing highlighting the study. “It’s not just about looking at the biological correlates of illness,” meaning looking at genetic markers etc, “but also looking at the environment in which people live, work, and/or are in therapy or in treatment.”

In a later interview, Dr. Liu said he was impressed by the fact that Dr. Rached, who has “a very deep personal connection to this community,” is using her own personal trauma to help identify others are at risk who may need future care.

Dr. Liu, whose own family sponsors Afghan refugees, said the research underlines the need to ensure training for psychiatrists everywhere to help manage the expatriate population. As it stands, there’s “a huge shortage of psychiatrists around the world,” particularly in countries that have been affected by trauma, said Dr. Liu.

The researchers and Dr. Liu reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

 

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The 2020 explosion that rocked Beirut, killing more than 200, injuring more than 7,000 and causing millions of dollars in damage had a significant impact on the mental health of Lebanese expatriates, leaving many grappling with anxiety, depression, and posttraumatic stress disorder, results of a new survey show.

The findings highlight the importance of considering the well-being of expatriates dealing with adverse events in their home countries, the investigators say.

research postdoctoral fellow, Northwestern University, Chicago
Dr. Gaëlle Rached
Dr. Gaëlle Rached

“Everyone, including doctors, should be more sensitive to expatriates around them; we should look out for them especially when their home country is going through a traumatic event,” study investigator Gaëlle Rached, MD, MSc, research postdoctoral fellow, Northwestern University, Chicago, told this news organization.

The findings were presented at the annual meeting of the American Psychiatric Association.
 

A historic explosion

It is estimated that approximately 14 million Lebanese citizens live outside their home country, which is more than double the population of Lebanon. However, the trauma-related mental health of these and other expatriate communities is understudied, said Dr. Rached.

“If you look at the literature, next to no one has examined expatriates’ mental health, and more so in the context of trauma.”

Dr. Rached has personal experience with the event. She was in Beirut on Aug. 4, 2020, when the Lebanese capital was rocked by an explosion attributed to ammonium nitrate stored at the city’s port. It was one of the biggest nonnuclear explosions in history and left hundreds homeless, killed, or injured. Dr. Rached watched as her father was injured and her house destroyed.

She heard anecdotes of Lebanese expatriates, experiencing trauma as a result of the blast. Many were unable to contact friends and loved ones in the wake of the tragedy.

“That prompted us to look at expatriate mental health following this traumatic incident,” she said.

She and her colleagues used various social media platforms to advertise the survey. They also reached out to the International Lebanese Medical Association, which has “a strong base” in the United States, said Dr. Rached.

She was “shocked” at how many expatriates responded. “People really wanted to speak up and express themselves” – whether because of survivor’s guilt or for some other reason, she said.

The survey included 670 adults with Lebanese nationality or who were first generation Lebanese living abroad. The study population had a median age 31 years and 62.2% female, most living in North America or Europe. Over one-third of respondents (270) had been living abroad from 1-5 years but many had been away for more than 20 years.

Study participants completed the Hopkins Symptoms Checklist (HSCL), which screens for anxiety and depression. On this checklist, a score of 1.75 is a typical cutoff value for symptomatic cases.

The investigators found 41.2% of participants scored higher than this threshold. Being younger, female and visiting Lebanon at the time of the blast, were factors associated with higher HSCL scores.
 

No tincture of time

Interestingly, the amount of time since emigrating from Lebanon was unrelated to the score. “Our results show that, no matter how long you’ve been away, you’re prone to the same negative outcome,” said Dr. Rached.

Of the total study population, 268 personally experienced the explosion and/or had close friends or family physically affected by it. These expatriates completed the Post-traumatic Checklist for DSM-5 (PCL-5).

Here, the analysis showed that many of these respondents (57.5%) scored above 33, which is higher than the threshold for probable PTSD. Being female was linked to higher PCL-5 scores.

These findings suggest the mental health of expatriates may be negatively affected by traumatic incidents in their home countries, even if they didn’t witness the event firsthand and have been away from their home country for a long time.

The results may be especially timely as many countries are taking in a flood of refugees fleeing war in Ukraine. However, Dr. Rached said, the findings from her research may not apply to Ukrainians.

“I don’t think the results can be extrapolated, given that the nature of the trauma is a little bit different,” she said, adding that the Beirut blast was “monumental” but it was over quickly. In contrast, there’s no end in sight for the Russian invasion of Ukraine.

Dr. Rached noted the study data are preliminary and limited because there’s no way to determine whether respondents had mental health issues before the blast.
 

Global psychiatrist shortage

Commenting on the study, Howard Liu, MD, chair of the University of Nebraska Medical Center department of psychiatry in Omaha, and incoming chair of the APA’s Council on Communications, said he found the presentation “fascinating on several levels.”

Dr. Howard Liu, University of Nebraska, Omaha
Dr. Howard Liu

It’s increasingly important for psychiatrists to be “trauma informed,” Dr. Liu told a press briefing highlighting the study. “It’s not just about looking at the biological correlates of illness,” meaning looking at genetic markers etc, “but also looking at the environment in which people live, work, and/or are in therapy or in treatment.”

In a later interview, Dr. Liu said he was impressed by the fact that Dr. Rached, who has “a very deep personal connection to this community,” is using her own personal trauma to help identify others are at risk who may need future care.

Dr. Liu, whose own family sponsors Afghan refugees, said the research underlines the need to ensure training for psychiatrists everywhere to help manage the expatriate population. As it stands, there’s “a huge shortage of psychiatrists around the world,” particularly in countries that have been affected by trauma, said Dr. Liu.

The researchers and Dr. Liu reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

 

The 2020 explosion that rocked Beirut, killing more than 200, injuring more than 7,000 and causing millions of dollars in damage had a significant impact on the mental health of Lebanese expatriates, leaving many grappling with anxiety, depression, and posttraumatic stress disorder, results of a new survey show.

The findings highlight the importance of considering the well-being of expatriates dealing with adverse events in their home countries, the investigators say.

research postdoctoral fellow, Northwestern University, Chicago
Dr. Gaëlle Rached
Dr. Gaëlle Rached

“Everyone, including doctors, should be more sensitive to expatriates around them; we should look out for them especially when their home country is going through a traumatic event,” study investigator Gaëlle Rached, MD, MSc, research postdoctoral fellow, Northwestern University, Chicago, told this news organization.

The findings were presented at the annual meeting of the American Psychiatric Association.
 

A historic explosion

It is estimated that approximately 14 million Lebanese citizens live outside their home country, which is more than double the population of Lebanon. However, the trauma-related mental health of these and other expatriate communities is understudied, said Dr. Rached.

“If you look at the literature, next to no one has examined expatriates’ mental health, and more so in the context of trauma.”

Dr. Rached has personal experience with the event. She was in Beirut on Aug. 4, 2020, when the Lebanese capital was rocked by an explosion attributed to ammonium nitrate stored at the city’s port. It was one of the biggest nonnuclear explosions in history and left hundreds homeless, killed, or injured. Dr. Rached watched as her father was injured and her house destroyed.

She heard anecdotes of Lebanese expatriates, experiencing trauma as a result of the blast. Many were unable to contact friends and loved ones in the wake of the tragedy.

“That prompted us to look at expatriate mental health following this traumatic incident,” she said.

She and her colleagues used various social media platforms to advertise the survey. They also reached out to the International Lebanese Medical Association, which has “a strong base” in the United States, said Dr. Rached.

She was “shocked” at how many expatriates responded. “People really wanted to speak up and express themselves” – whether because of survivor’s guilt or for some other reason, she said.

The survey included 670 adults with Lebanese nationality or who were first generation Lebanese living abroad. The study population had a median age 31 years and 62.2% female, most living in North America or Europe. Over one-third of respondents (270) had been living abroad from 1-5 years but many had been away for more than 20 years.

Study participants completed the Hopkins Symptoms Checklist (HSCL), which screens for anxiety and depression. On this checklist, a score of 1.75 is a typical cutoff value for symptomatic cases.

The investigators found 41.2% of participants scored higher than this threshold. Being younger, female and visiting Lebanon at the time of the blast, were factors associated with higher HSCL scores.
 

No tincture of time

Interestingly, the amount of time since emigrating from Lebanon was unrelated to the score. “Our results show that, no matter how long you’ve been away, you’re prone to the same negative outcome,” said Dr. Rached.

Of the total study population, 268 personally experienced the explosion and/or had close friends or family physically affected by it. These expatriates completed the Post-traumatic Checklist for DSM-5 (PCL-5).

Here, the analysis showed that many of these respondents (57.5%) scored above 33, which is higher than the threshold for probable PTSD. Being female was linked to higher PCL-5 scores.

These findings suggest the mental health of expatriates may be negatively affected by traumatic incidents in their home countries, even if they didn’t witness the event firsthand and have been away from their home country for a long time.

The results may be especially timely as many countries are taking in a flood of refugees fleeing war in Ukraine. However, Dr. Rached said, the findings from her research may not apply to Ukrainians.

“I don’t think the results can be extrapolated, given that the nature of the trauma is a little bit different,” she said, adding that the Beirut blast was “monumental” but it was over quickly. In contrast, there’s no end in sight for the Russian invasion of Ukraine.

Dr. Rached noted the study data are preliminary and limited because there’s no way to determine whether respondents had mental health issues before the blast.
 

Global psychiatrist shortage

Commenting on the study, Howard Liu, MD, chair of the University of Nebraska Medical Center department of psychiatry in Omaha, and incoming chair of the APA’s Council on Communications, said he found the presentation “fascinating on several levels.”

Dr. Howard Liu, University of Nebraska, Omaha
Dr. Howard Liu

It’s increasingly important for psychiatrists to be “trauma informed,” Dr. Liu told a press briefing highlighting the study. “It’s not just about looking at the biological correlates of illness,” meaning looking at genetic markers etc, “but also looking at the environment in which people live, work, and/or are in therapy or in treatment.”

In a later interview, Dr. Liu said he was impressed by the fact that Dr. Rached, who has “a very deep personal connection to this community,” is using her own personal trauma to help identify others are at risk who may need future care.

Dr. Liu, whose own family sponsors Afghan refugees, said the research underlines the need to ensure training for psychiatrists everywhere to help manage the expatriate population. As it stands, there’s “a huge shortage of psychiatrists around the world,” particularly in countries that have been affected by trauma, said Dr. Liu.

The researchers and Dr. Liu reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

 

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Innovative med school curriculum could help curb the opioid epidemic

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An opioid-centered curriculum for medical students improves awareness of pain management and treatment of opioid use disorder (OUD) and may help mitigate the current opioid crisis in the United States, new research suggests.

“Our study showed that implementing training for medical students about opioid use disorder and its treatment improves knowledge and understanding of clinical principles and may better prepare students to treat patients with this disorder,” study investigator Kimberly Hu, MD, psychiatry resident, Ohio State University, Columbus, told this news organization.

The findings were presented at the annual meeting of the American Psychiatric Association.

The U.S. opioid epidemic claims thousands of lives every year, and there’s evidence it’s getting worse, said Dr. Hu. U.S. data from December 2020 to December 2021 show opioid-related deaths increased by almost 15%.

In 2019, about 70% of the nearly 71,000 drug overdose deaths in the United States involved opioids and now it exceeds 100,000 per year, said Dr. Hu. She noted 80% of heroin users report their addiction started with prescription opioids, data that she described as “pretty staggering.”

Although treatments such as buprenorphine are available for OUD, “insufficient access to medications for opioid use disorder remains a significant barrier for patients,” said Dr. Hu.

“Training the next generation of physicians across all specialties is one way that we can work to improve access to care and improve the health and well-being of our patients.”

The study, which is ongoing, included 405 3rd-year medical students at Ohio State. Researchers provided these students with in-person or virtual (during the pandemic) training in buprenorphine prescribing and in-person clinical experience.

Dr. Hu and her colleagues tested the students before and after the intervention and estimated improvement in knowledge (score 0-23) and approach to clinical management principles (1-5).

The investigators found a statistically significant increase in overall knowledge (from a mean total score of 18.34 to 19.32; P < .001). There was also a statistically significant increase in self-reported understanding of clinical management principles related to screening for and treating OUDs (from a mean of 3.12 to a mean of 4.02; P < .001).

An additional evaluation survey was completed by 162 students at the end of the program. About 83% of these students said they knew how to manage acute pain, 62% felt they knew how to manage chronic pain, and 77% agreed they knew how to screen a patient for OUD.

Dr. Hu noted 3rd-year medical students are a little over halfway through medical school, after which they will go into residency in various specialties. Providing them with this knowledge early on allows them to incorporate it as they continue their training, she said.

“If they are able to screen their patients in any specialty they eventually choose to go into, then they can help link these patients to resources early and make sure there aren’t patients who are slipping through the cracks.”
 

Worthwhile, important research

Howard Liu, MD, chair of the department of psychiatry at the University of Nebraska Medical Center, Omaha, and incoming chair of the APA’s Council on Communications, applauded the study.

The proposed curriculum, he said, instills confidence in students and teaches important lessons they can apply no matter what field they choose.

Dr. Howard Liu, University of Nebraska, Omaha
Dr. Howard Liu

Dr. Liu, who moderated a press briefing highlighting the study, noted every state is affected differently by the opioid epidemic, but the shortage of appropriate treatments for OUD is nationwide.

Commenting on the study, addiction specialist Elie G. Aoun, MD, of the division of law, medicine, and psychiatry at Columbia University, New York, said this research is “very worthwhile and important.”

He noted that attitudes about addiction need to change. When he taught medical students about substance use disorders, he was struck by some of their negative beliefs about addiction. For example, considering addicts as “junkies” who are “taking resources away” from what they perceive as more deserving patients.

Addiction has been ignored in medicine for too long, added Dr. Aoun. He noted the requirement for addiction training for psychiatry residents is 2 months while they spend 4 months learning internal medicine. “That makes no sense,” he said.

“And now with the opioid epidemic, we’re faced with the consequences of dismissing addiction for such a long time.”

A lack of understanding about addiction, and the “very limited number” of experienced people treating addictions, has contributed to the “huge problem” experts now face in treating addictions, said Dr. Aoun.

“So you want to approach this problem from as many different angles as you can.”

He praised the study for presenting “a framework to ‘medicalize’ the addiction model” for students. This, he said, will help them build empathy and see those with a substance use disorder as no different from other patients with medical conditions.

A curriculum such as the one presented by Dr. Hu and colleagues may spur more medical students into the addiction field, he said. “It may make them more willing to treat patients with addiction using evidence-based medicine rather than dismissing them.”

The study was supported by the Substance Abuse and Mental Health Services Administration.

A version of this article first appeared on Medscape.com.

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An opioid-centered curriculum for medical students improves awareness of pain management and treatment of opioid use disorder (OUD) and may help mitigate the current opioid crisis in the United States, new research suggests.

“Our study showed that implementing training for medical students about opioid use disorder and its treatment improves knowledge and understanding of clinical principles and may better prepare students to treat patients with this disorder,” study investigator Kimberly Hu, MD, psychiatry resident, Ohio State University, Columbus, told this news organization.

The findings were presented at the annual meeting of the American Psychiatric Association.

The U.S. opioid epidemic claims thousands of lives every year, and there’s evidence it’s getting worse, said Dr. Hu. U.S. data from December 2020 to December 2021 show opioid-related deaths increased by almost 15%.

In 2019, about 70% of the nearly 71,000 drug overdose deaths in the United States involved opioids and now it exceeds 100,000 per year, said Dr. Hu. She noted 80% of heroin users report their addiction started with prescription opioids, data that she described as “pretty staggering.”

Although treatments such as buprenorphine are available for OUD, “insufficient access to medications for opioid use disorder remains a significant barrier for patients,” said Dr. Hu.

“Training the next generation of physicians across all specialties is one way that we can work to improve access to care and improve the health and well-being of our patients.”

The study, which is ongoing, included 405 3rd-year medical students at Ohio State. Researchers provided these students with in-person or virtual (during the pandemic) training in buprenorphine prescribing and in-person clinical experience.

Dr. Hu and her colleagues tested the students before and after the intervention and estimated improvement in knowledge (score 0-23) and approach to clinical management principles (1-5).

The investigators found a statistically significant increase in overall knowledge (from a mean total score of 18.34 to 19.32; P < .001). There was also a statistically significant increase in self-reported understanding of clinical management principles related to screening for and treating OUDs (from a mean of 3.12 to a mean of 4.02; P < .001).

An additional evaluation survey was completed by 162 students at the end of the program. About 83% of these students said they knew how to manage acute pain, 62% felt they knew how to manage chronic pain, and 77% agreed they knew how to screen a patient for OUD.

Dr. Hu noted 3rd-year medical students are a little over halfway through medical school, after which they will go into residency in various specialties. Providing them with this knowledge early on allows them to incorporate it as they continue their training, she said.

“If they are able to screen their patients in any specialty they eventually choose to go into, then they can help link these patients to resources early and make sure there aren’t patients who are slipping through the cracks.”
 

Worthwhile, important research

Howard Liu, MD, chair of the department of psychiatry at the University of Nebraska Medical Center, Omaha, and incoming chair of the APA’s Council on Communications, applauded the study.

The proposed curriculum, he said, instills confidence in students and teaches important lessons they can apply no matter what field they choose.

Dr. Howard Liu, University of Nebraska, Omaha
Dr. Howard Liu

Dr. Liu, who moderated a press briefing highlighting the study, noted every state is affected differently by the opioid epidemic, but the shortage of appropriate treatments for OUD is nationwide.

Commenting on the study, addiction specialist Elie G. Aoun, MD, of the division of law, medicine, and psychiatry at Columbia University, New York, said this research is “very worthwhile and important.”

He noted that attitudes about addiction need to change. When he taught medical students about substance use disorders, he was struck by some of their negative beliefs about addiction. For example, considering addicts as “junkies” who are “taking resources away” from what they perceive as more deserving patients.

Addiction has been ignored in medicine for too long, added Dr. Aoun. He noted the requirement for addiction training for psychiatry residents is 2 months while they spend 4 months learning internal medicine. “That makes no sense,” he said.

“And now with the opioid epidemic, we’re faced with the consequences of dismissing addiction for such a long time.”

A lack of understanding about addiction, and the “very limited number” of experienced people treating addictions, has contributed to the “huge problem” experts now face in treating addictions, said Dr. Aoun.

“So you want to approach this problem from as many different angles as you can.”

He praised the study for presenting “a framework to ‘medicalize’ the addiction model” for students. This, he said, will help them build empathy and see those with a substance use disorder as no different from other patients with medical conditions.

A curriculum such as the one presented by Dr. Hu and colleagues may spur more medical students into the addiction field, he said. “It may make them more willing to treat patients with addiction using evidence-based medicine rather than dismissing them.”

The study was supported by the Substance Abuse and Mental Health Services Administration.

A version of this article first appeared on Medscape.com.

An opioid-centered curriculum for medical students improves awareness of pain management and treatment of opioid use disorder (OUD) and may help mitigate the current opioid crisis in the United States, new research suggests.

“Our study showed that implementing training for medical students about opioid use disorder and its treatment improves knowledge and understanding of clinical principles and may better prepare students to treat patients with this disorder,” study investigator Kimberly Hu, MD, psychiatry resident, Ohio State University, Columbus, told this news organization.

The findings were presented at the annual meeting of the American Psychiatric Association.

The U.S. opioid epidemic claims thousands of lives every year, and there’s evidence it’s getting worse, said Dr. Hu. U.S. data from December 2020 to December 2021 show opioid-related deaths increased by almost 15%.

In 2019, about 70% of the nearly 71,000 drug overdose deaths in the United States involved opioids and now it exceeds 100,000 per year, said Dr. Hu. She noted 80% of heroin users report their addiction started with prescription opioids, data that she described as “pretty staggering.”

Although treatments such as buprenorphine are available for OUD, “insufficient access to medications for opioid use disorder remains a significant barrier for patients,” said Dr. Hu.

“Training the next generation of physicians across all specialties is one way that we can work to improve access to care and improve the health and well-being of our patients.”

The study, which is ongoing, included 405 3rd-year medical students at Ohio State. Researchers provided these students with in-person or virtual (during the pandemic) training in buprenorphine prescribing and in-person clinical experience.

Dr. Hu and her colleagues tested the students before and after the intervention and estimated improvement in knowledge (score 0-23) and approach to clinical management principles (1-5).

The investigators found a statistically significant increase in overall knowledge (from a mean total score of 18.34 to 19.32; P < .001). There was also a statistically significant increase in self-reported understanding of clinical management principles related to screening for and treating OUDs (from a mean of 3.12 to a mean of 4.02; P < .001).

An additional evaluation survey was completed by 162 students at the end of the program. About 83% of these students said they knew how to manage acute pain, 62% felt they knew how to manage chronic pain, and 77% agreed they knew how to screen a patient for OUD.

Dr. Hu noted 3rd-year medical students are a little over halfway through medical school, after which they will go into residency in various specialties. Providing them with this knowledge early on allows them to incorporate it as they continue their training, she said.

“If they are able to screen their patients in any specialty they eventually choose to go into, then they can help link these patients to resources early and make sure there aren’t patients who are slipping through the cracks.”
 

Worthwhile, important research

Howard Liu, MD, chair of the department of psychiatry at the University of Nebraska Medical Center, Omaha, and incoming chair of the APA’s Council on Communications, applauded the study.

The proposed curriculum, he said, instills confidence in students and teaches important lessons they can apply no matter what field they choose.

Dr. Howard Liu, University of Nebraska, Omaha
Dr. Howard Liu

Dr. Liu, who moderated a press briefing highlighting the study, noted every state is affected differently by the opioid epidemic, but the shortage of appropriate treatments for OUD is nationwide.

Commenting on the study, addiction specialist Elie G. Aoun, MD, of the division of law, medicine, and psychiatry at Columbia University, New York, said this research is “very worthwhile and important.”

He noted that attitudes about addiction need to change. When he taught medical students about substance use disorders, he was struck by some of their negative beliefs about addiction. For example, considering addicts as “junkies” who are “taking resources away” from what they perceive as more deserving patients.

Addiction has been ignored in medicine for too long, added Dr. Aoun. He noted the requirement for addiction training for psychiatry residents is 2 months while they spend 4 months learning internal medicine. “That makes no sense,” he said.

“And now with the opioid epidemic, we’re faced with the consequences of dismissing addiction for such a long time.”

A lack of understanding about addiction, and the “very limited number” of experienced people treating addictions, has contributed to the “huge problem” experts now face in treating addictions, said Dr. Aoun.

“So you want to approach this problem from as many different angles as you can.”

He praised the study for presenting “a framework to ‘medicalize’ the addiction model” for students. This, he said, will help them build empathy and see those with a substance use disorder as no different from other patients with medical conditions.

A curriculum such as the one presented by Dr. Hu and colleagues may spur more medical students into the addiction field, he said. “It may make them more willing to treat patients with addiction using evidence-based medicine rather than dismissing them.”

The study was supported by the Substance Abuse and Mental Health Services Administration.

A version of this article first appeared on Medscape.com.

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A psychiatric patient confesses to murder: Now what?

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– The patient, a 60-year-old woman who’d just tried to kill herself by overdosing on gabapentin, felt the need to make a confession. As she told a resident psychiatrist late one night at a Philadelphia crisis response center, she’d just murdered two people and buried them in her backyard. More details kept coming, including who was dead and where their bodies were.

It didn’t take long for the attending physician’s phone to ring as the resident sought guidance. This wasn’t a typical “duty to warn” case since there was no one to warn of a threat of violence. But then what kind of case was it? As Meghan Musselman, MD, and colleagues noted in a report presented at the annual meeting of the American Psychiatric Association, the law and medical ethics didn’t present a clear-cut solution to whether the patient’s claim should be reported to the authorities.

Psychiatry and Behavioral Science, Lewis Katz School of Medicine at Temple University, Philadelphia
Dr. Meghan Musselman

“This was much more of a gray zone case than we typically see,” said Dr. Musselman, of the department of psychiatry at Temple University in Philadelphia, in an interview. “If someone is threatening to harm someone, most states have statutes about what to do in that situation. The same doesn’t really exist for when the crime has already happened.”

Even so, might the existing “duty to warn/protect” laws be helpful as a guide to what to do? Maybe, but it’s complicated. The laws, which address the waiving of therapist-patient confidentiality when violence is threatened, are widely variable. Some don’t specifically cover psychiatrists, according to the National Conference of State Legislatures. Some simply allow – but don’t require – certain mental-health professionals to take action regarding threats of violence without getting in trouble themselves.

There are no duty to warn/protect laws in Nevada, North Dakota, North Carolina, and Maine. Pennsylvania requires “mental-health professionals” to act when there’s a “clear and immediate danger to others or to society.”

In an interview, Columbia University, New York, psychiatrist and medical law/ethics specialist Paul S. Appelbaum, MD, said that “with the exception of situations like child abuse or elder abuse, for which psychiatrists are mandatory reporters, psychiatrists generally have the same responsibilities for reporting crimes as other citizens.”

Dr. Paul Appelbaum
Dr. Paul Appelbaum

He added that there is a crime in English common law known as “misprision” that refers to failing to report a felony. “A few states still have misprision statutes, but courts have tended to interpret them to require an affirmative act to conceal a crime, not just failure to report,” he said. “Unless the patient’s confession indicates a continuing threat to other people – e.g., a serial rapist or murderer – there is probably no obligation to report a previous crime.”

In this case, Dr. Musselman said, the physicians thought they might be able to waive confidentiality because it was possible that the alleged murder victims were still alive and in need of help.

However, the patient ultimately took the decision out of the hands of the psychiatrists and agreed to confess to the police. There’s a happy ending: The patient later recanted the story, Dr. Musselman said, and there was no follow-up by the authorities.

What should psychiatrists do in a similar situation? Besides the law, Dr. Musselman said, it’s important to consider medical ethics, confidentiality, and the greater good. “Doctors may have to ask themselves: Would I rather be sued because I’m breaking confidentiality or potentially play a part in someone’s suffering?”

She recommended reaching out to attorneys for legal guidance. “There’s a saying in forensic psychiatry by [Harvard University psychiatrist] Thomas Gutheil: Never worry alone.”

Dr. Applebaum agreed, and added: “Psychiatrists should consider the credibility of the patient’s confession: Could it represent a delusion? Is it being proffered as a way of manipulating the therapist? What is the extent to which, if valid, it indicates an ongoing threat to others? Is the patient is willing to contact the police and admit to the crime or authorize the psychiatrist to do so? Only in the case of a credible confession, an ongoing threat, and a patient unwilling to contact the police themselves should the psychiatrist seriously consider breaching confidentiality to report.”

No study funding or disclosures were reported.

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– The patient, a 60-year-old woman who’d just tried to kill herself by overdosing on gabapentin, felt the need to make a confession. As she told a resident psychiatrist late one night at a Philadelphia crisis response center, she’d just murdered two people and buried them in her backyard. More details kept coming, including who was dead and where their bodies were.

It didn’t take long for the attending physician’s phone to ring as the resident sought guidance. This wasn’t a typical “duty to warn” case since there was no one to warn of a threat of violence. But then what kind of case was it? As Meghan Musselman, MD, and colleagues noted in a report presented at the annual meeting of the American Psychiatric Association, the law and medical ethics didn’t present a clear-cut solution to whether the patient’s claim should be reported to the authorities.

Psychiatry and Behavioral Science, Lewis Katz School of Medicine at Temple University, Philadelphia
Dr. Meghan Musselman

“This was much more of a gray zone case than we typically see,” said Dr. Musselman, of the department of psychiatry at Temple University in Philadelphia, in an interview. “If someone is threatening to harm someone, most states have statutes about what to do in that situation. The same doesn’t really exist for when the crime has already happened.”

Even so, might the existing “duty to warn/protect” laws be helpful as a guide to what to do? Maybe, but it’s complicated. The laws, which address the waiving of therapist-patient confidentiality when violence is threatened, are widely variable. Some don’t specifically cover psychiatrists, according to the National Conference of State Legislatures. Some simply allow – but don’t require – certain mental-health professionals to take action regarding threats of violence without getting in trouble themselves.

There are no duty to warn/protect laws in Nevada, North Dakota, North Carolina, and Maine. Pennsylvania requires “mental-health professionals” to act when there’s a “clear and immediate danger to others or to society.”

In an interview, Columbia University, New York, psychiatrist and medical law/ethics specialist Paul S. Appelbaum, MD, said that “with the exception of situations like child abuse or elder abuse, for which psychiatrists are mandatory reporters, psychiatrists generally have the same responsibilities for reporting crimes as other citizens.”

Dr. Paul Appelbaum
Dr. Paul Appelbaum

He added that there is a crime in English common law known as “misprision” that refers to failing to report a felony. “A few states still have misprision statutes, but courts have tended to interpret them to require an affirmative act to conceal a crime, not just failure to report,” he said. “Unless the patient’s confession indicates a continuing threat to other people – e.g., a serial rapist or murderer – there is probably no obligation to report a previous crime.”

In this case, Dr. Musselman said, the physicians thought they might be able to waive confidentiality because it was possible that the alleged murder victims were still alive and in need of help.

However, the patient ultimately took the decision out of the hands of the psychiatrists and agreed to confess to the police. There’s a happy ending: The patient later recanted the story, Dr. Musselman said, and there was no follow-up by the authorities.

What should psychiatrists do in a similar situation? Besides the law, Dr. Musselman said, it’s important to consider medical ethics, confidentiality, and the greater good. “Doctors may have to ask themselves: Would I rather be sued because I’m breaking confidentiality or potentially play a part in someone’s suffering?”

She recommended reaching out to attorneys for legal guidance. “There’s a saying in forensic psychiatry by [Harvard University psychiatrist] Thomas Gutheil: Never worry alone.”

Dr. Applebaum agreed, and added: “Psychiatrists should consider the credibility of the patient’s confession: Could it represent a delusion? Is it being proffered as a way of manipulating the therapist? What is the extent to which, if valid, it indicates an ongoing threat to others? Is the patient is willing to contact the police and admit to the crime or authorize the psychiatrist to do so? Only in the case of a credible confession, an ongoing threat, and a patient unwilling to contact the police themselves should the psychiatrist seriously consider breaching confidentiality to report.”

No study funding or disclosures were reported.

– The patient, a 60-year-old woman who’d just tried to kill herself by overdosing on gabapentin, felt the need to make a confession. As she told a resident psychiatrist late one night at a Philadelphia crisis response center, she’d just murdered two people and buried them in her backyard. More details kept coming, including who was dead and where their bodies were.

It didn’t take long for the attending physician’s phone to ring as the resident sought guidance. This wasn’t a typical “duty to warn” case since there was no one to warn of a threat of violence. But then what kind of case was it? As Meghan Musselman, MD, and colleagues noted in a report presented at the annual meeting of the American Psychiatric Association, the law and medical ethics didn’t present a clear-cut solution to whether the patient’s claim should be reported to the authorities.

Psychiatry and Behavioral Science, Lewis Katz School of Medicine at Temple University, Philadelphia
Dr. Meghan Musselman

“This was much more of a gray zone case than we typically see,” said Dr. Musselman, of the department of psychiatry at Temple University in Philadelphia, in an interview. “If someone is threatening to harm someone, most states have statutes about what to do in that situation. The same doesn’t really exist for when the crime has already happened.”

Even so, might the existing “duty to warn/protect” laws be helpful as a guide to what to do? Maybe, but it’s complicated. The laws, which address the waiving of therapist-patient confidentiality when violence is threatened, are widely variable. Some don’t specifically cover psychiatrists, according to the National Conference of State Legislatures. Some simply allow – but don’t require – certain mental-health professionals to take action regarding threats of violence without getting in trouble themselves.

There are no duty to warn/protect laws in Nevada, North Dakota, North Carolina, and Maine. Pennsylvania requires “mental-health professionals” to act when there’s a “clear and immediate danger to others or to society.”

In an interview, Columbia University, New York, psychiatrist and medical law/ethics specialist Paul S. Appelbaum, MD, said that “with the exception of situations like child abuse or elder abuse, for which psychiatrists are mandatory reporters, psychiatrists generally have the same responsibilities for reporting crimes as other citizens.”

Dr. Paul Appelbaum
Dr. Paul Appelbaum

He added that there is a crime in English common law known as “misprision” that refers to failing to report a felony. “A few states still have misprision statutes, but courts have tended to interpret them to require an affirmative act to conceal a crime, not just failure to report,” he said. “Unless the patient’s confession indicates a continuing threat to other people – e.g., a serial rapist or murderer – there is probably no obligation to report a previous crime.”

In this case, Dr. Musselman said, the physicians thought they might be able to waive confidentiality because it was possible that the alleged murder victims were still alive and in need of help.

However, the patient ultimately took the decision out of the hands of the psychiatrists and agreed to confess to the police. There’s a happy ending: The patient later recanted the story, Dr. Musselman said, and there was no follow-up by the authorities.

What should psychiatrists do in a similar situation? Besides the law, Dr. Musselman said, it’s important to consider medical ethics, confidentiality, and the greater good. “Doctors may have to ask themselves: Would I rather be sued because I’m breaking confidentiality or potentially play a part in someone’s suffering?”

She recommended reaching out to attorneys for legal guidance. “There’s a saying in forensic psychiatry by [Harvard University psychiatrist] Thomas Gutheil: Never worry alone.”

Dr. Applebaum agreed, and added: “Psychiatrists should consider the credibility of the patient’s confession: Could it represent a delusion? Is it being proffered as a way of manipulating the therapist? What is the extent to which, if valid, it indicates an ongoing threat to others? Is the patient is willing to contact the police and admit to the crime or authorize the psychiatrist to do so? Only in the case of a credible confession, an ongoing threat, and a patient unwilling to contact the police themselves should the psychiatrist seriously consider breaching confidentiality to report.”

No study funding or disclosures were reported.

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Anxiety in America: COVID ‘takes a backseat’ to global events

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NEW ORLEANS– With 2 years of COVID-19 in the rearview mirror, anxiety among U.S. adults has turned instead toward global events, results from the annual Healthy Minds Poll from the American Psychiatric Association show.

“It’s not surprising that recent events, such as the war in Ukraine, racially motivated mass shootings, or the impacts of climate change, are weighing heavily on Americans’ minds,” APA president Vivian Pender, MD, said in a news release. 

Dr. Vivian Pender
Dr. Vivian Pender

“COVID-19 in a way has taken a back seat, but the pandemic and its mental health effects are very much still with us. It’s important that we are cognizant of that and continue to work to ensure people who need psychiatric care, whether the causes are tied to the pandemic or to other issues, can access it,” Dr. Pender added.

Results from the 2022’s poll were released May 22 during the annual meeting of the APA.
 

Record low COVID anxiety

The poll was conducted by Morning Consult between April 23-24 and included 2,210 adult participants.

Results showed that anxiety about COVID is at its recorded lowest, with 50% of respondents indicating they are anxious about the pandemic. This was down from 65% in 2021 and from 75% in 2020.

Instead, nearly three-quarters (73%) of adults are somewhat or extremely anxious about current events happening around the world, 64% are anxious about keeping themselves or their families safe, and 60% worry about their health in general.

Overall, about one-third (32%) reported being more anxious now than in 2021, 46% reported no change in their anxiety level, and 18% were less anxious.

About one-quarter (26%) have spoken with a mental health care professional in the past few years, which is down from 34% in 2021. In addition, Hispanic (36%) and Black (35%) adults were more likely to have reached out for help than White (25%) adults.

Despite the U.S. Surgeon General’s recent advisory on the mental health crisis among children, the poll results also showed that Americans are less concerned about their children’s mental health than in 2021. A total of 41% of parents expressed concern about this topic, which was down from 53% in 2021.

Still, 40% of parents said their children had received help from a mental health professional since the pandemic hit. Of that group, 36% sought help before the pandemic, whereas half said the pandemic had caused mental health issues for their children.

Dr. Saul Levin, APA CEO and Medical Director Saul Levin, MD, MPA--Washington
Dr. Saul Levin

“While the overall level of concern has dropped, still 4 in 10 parents are worried about how their children are doing, and a third are having issues with access to care,” Saul Levin, MD, CEO and medical director of the APA, said in the release.

“This is unacceptable and as a nation, we need to invest in the kind of systems that will ensure any parent who’s worried about their child has access to lifesaving treatment,” Dr. Levin added.
 

Workplace mental health

In addition, the poll showed employees often have a tough time getting mental health support from employers, or are hesitant to ask for help.

“What’s troubling about the results of this poll is that, even as the pandemic has continued and its mental health effects wear on, fewer employees are reporting that they have access to mental health services,” Dr. Pender said. 

“Workplaces need to ensure that they are paying attention to what their employees need, particularly now, and moving away from mental health benefits isn’t the right move,” she added.

About half (48%) of those polled said they can discuss mental health openly and honestly with their supervisor, down from 56% in 2021 and 62% in 2020.

Only about half (52%) said they feel comfortable using mental health services with their current employer, compared with 64% in 2021 and 67% in 2020.

In addition, fewer workers felt their employer is offering sufficient mental health resources and benefits. In 2022, 53% of workers thought resources and benefits were adequate, which was down from 65% in 2021 and 68% in 2020.

“It’s quite concerning to see that fewer people feel comfortable discussing mental health with a supervisor, at a time when people experiencing symptoms of anxiety, depression, and other conditions are on the rise and impact nearly every aspect of work, including productivity, performance, retention, and overall health care costs,” said Darcy Gruttadaro, JD, director of the APA Foundation’s Center for Workplace Mental Health.

“As rates of these conditions rise, we should see more employees knowing about available workplace mental health resources, not less,” Ms. Gruttadaro said.
 

Strong bipartisan support 

Perhaps unexpectedly, the poll shows strong support among Democrats, Republicans, and Independents for three APA-backed approaches to improve timely access to mental health care and treatment.

Specifically, about three-quarters of those polled supported making it easier to see a mental health professional via telehealth, allowing patients to receive mental health care through a primary care provider, and funding mental health care professionals to work in rural or urban communities that are traditionally underserved.

“We’re in a moment when mental health is a big part of the national conversation, and clearly political party doesn’t matter as much on this issue,” Dr. Pender noted. 

“It’s a rare thing in Washington these days to see such a resounding endorsement, but there is strong support for these practical workable solutions that mean more access to mental health care,” she said.

“What you see in this poll is agreement: It’s hard to access mental [health care] but we do have great solutions that could work across party lines,” Dr. Levin added.

“Many policy makers, in the administration and in Congress, are already putting these ideas into action, and they should feel encouraged that the public wants to see Congress act on them,” he said.

A version of this article first appeared on Medscape.com.

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NEW ORLEANS– With 2 years of COVID-19 in the rearview mirror, anxiety among U.S. adults has turned instead toward global events, results from the annual Healthy Minds Poll from the American Psychiatric Association show.

“It’s not surprising that recent events, such as the war in Ukraine, racially motivated mass shootings, or the impacts of climate change, are weighing heavily on Americans’ minds,” APA president Vivian Pender, MD, said in a news release. 

Dr. Vivian Pender
Dr. Vivian Pender

“COVID-19 in a way has taken a back seat, but the pandemic and its mental health effects are very much still with us. It’s important that we are cognizant of that and continue to work to ensure people who need psychiatric care, whether the causes are tied to the pandemic or to other issues, can access it,” Dr. Pender added.

Results from the 2022’s poll were released May 22 during the annual meeting of the APA.
 

Record low COVID anxiety

The poll was conducted by Morning Consult between April 23-24 and included 2,210 adult participants.

Results showed that anxiety about COVID is at its recorded lowest, with 50% of respondents indicating they are anxious about the pandemic. This was down from 65% in 2021 and from 75% in 2020.

Instead, nearly three-quarters (73%) of adults are somewhat or extremely anxious about current events happening around the world, 64% are anxious about keeping themselves or their families safe, and 60% worry about their health in general.

Overall, about one-third (32%) reported being more anxious now than in 2021, 46% reported no change in their anxiety level, and 18% were less anxious.

About one-quarter (26%) have spoken with a mental health care professional in the past few years, which is down from 34% in 2021. In addition, Hispanic (36%) and Black (35%) adults were more likely to have reached out for help than White (25%) adults.

Despite the U.S. Surgeon General’s recent advisory on the mental health crisis among children, the poll results also showed that Americans are less concerned about their children’s mental health than in 2021. A total of 41% of parents expressed concern about this topic, which was down from 53% in 2021.

Still, 40% of parents said their children had received help from a mental health professional since the pandemic hit. Of that group, 36% sought help before the pandemic, whereas half said the pandemic had caused mental health issues for their children.

Dr. Saul Levin, APA CEO and Medical Director Saul Levin, MD, MPA--Washington
Dr. Saul Levin

“While the overall level of concern has dropped, still 4 in 10 parents are worried about how their children are doing, and a third are having issues with access to care,” Saul Levin, MD, CEO and medical director of the APA, said in the release.

“This is unacceptable and as a nation, we need to invest in the kind of systems that will ensure any parent who’s worried about their child has access to lifesaving treatment,” Dr. Levin added.
 

Workplace mental health

In addition, the poll showed employees often have a tough time getting mental health support from employers, or are hesitant to ask for help.

“What’s troubling about the results of this poll is that, even as the pandemic has continued and its mental health effects wear on, fewer employees are reporting that they have access to mental health services,” Dr. Pender said. 

“Workplaces need to ensure that they are paying attention to what their employees need, particularly now, and moving away from mental health benefits isn’t the right move,” she added.

About half (48%) of those polled said they can discuss mental health openly and honestly with their supervisor, down from 56% in 2021 and 62% in 2020.

Only about half (52%) said they feel comfortable using mental health services with their current employer, compared with 64% in 2021 and 67% in 2020.

In addition, fewer workers felt their employer is offering sufficient mental health resources and benefits. In 2022, 53% of workers thought resources and benefits were adequate, which was down from 65% in 2021 and 68% in 2020.

“It’s quite concerning to see that fewer people feel comfortable discussing mental health with a supervisor, at a time when people experiencing symptoms of anxiety, depression, and other conditions are on the rise and impact nearly every aspect of work, including productivity, performance, retention, and overall health care costs,” said Darcy Gruttadaro, JD, director of the APA Foundation’s Center for Workplace Mental Health.

“As rates of these conditions rise, we should see more employees knowing about available workplace mental health resources, not less,” Ms. Gruttadaro said.
 

Strong bipartisan support 

Perhaps unexpectedly, the poll shows strong support among Democrats, Republicans, and Independents for three APA-backed approaches to improve timely access to mental health care and treatment.

Specifically, about three-quarters of those polled supported making it easier to see a mental health professional via telehealth, allowing patients to receive mental health care through a primary care provider, and funding mental health care professionals to work in rural or urban communities that are traditionally underserved.

“We’re in a moment when mental health is a big part of the national conversation, and clearly political party doesn’t matter as much on this issue,” Dr. Pender noted. 

“It’s a rare thing in Washington these days to see such a resounding endorsement, but there is strong support for these practical workable solutions that mean more access to mental health care,” she said.

“What you see in this poll is agreement: It’s hard to access mental [health care] but we do have great solutions that could work across party lines,” Dr. Levin added.

“Many policy makers, in the administration and in Congress, are already putting these ideas into action, and they should feel encouraged that the public wants to see Congress act on them,” he said.

A version of this article first appeared on Medscape.com.

NEW ORLEANS– With 2 years of COVID-19 in the rearview mirror, anxiety among U.S. adults has turned instead toward global events, results from the annual Healthy Minds Poll from the American Psychiatric Association show.

“It’s not surprising that recent events, such as the war in Ukraine, racially motivated mass shootings, or the impacts of climate change, are weighing heavily on Americans’ minds,” APA president Vivian Pender, MD, said in a news release. 

Dr. Vivian Pender
Dr. Vivian Pender

“COVID-19 in a way has taken a back seat, but the pandemic and its mental health effects are very much still with us. It’s important that we are cognizant of that and continue to work to ensure people who need psychiatric care, whether the causes are tied to the pandemic or to other issues, can access it,” Dr. Pender added.

Results from the 2022’s poll were released May 22 during the annual meeting of the APA.
 

Record low COVID anxiety

The poll was conducted by Morning Consult between April 23-24 and included 2,210 adult participants.

Results showed that anxiety about COVID is at its recorded lowest, with 50% of respondents indicating they are anxious about the pandemic. This was down from 65% in 2021 and from 75% in 2020.

Instead, nearly three-quarters (73%) of adults are somewhat or extremely anxious about current events happening around the world, 64% are anxious about keeping themselves or their families safe, and 60% worry about their health in general.

Overall, about one-third (32%) reported being more anxious now than in 2021, 46% reported no change in their anxiety level, and 18% were less anxious.

About one-quarter (26%) have spoken with a mental health care professional in the past few years, which is down from 34% in 2021. In addition, Hispanic (36%) and Black (35%) adults were more likely to have reached out for help than White (25%) adults.

Despite the U.S. Surgeon General’s recent advisory on the mental health crisis among children, the poll results also showed that Americans are less concerned about their children’s mental health than in 2021. A total of 41% of parents expressed concern about this topic, which was down from 53% in 2021.

Still, 40% of parents said their children had received help from a mental health professional since the pandemic hit. Of that group, 36% sought help before the pandemic, whereas half said the pandemic had caused mental health issues for their children.

Dr. Saul Levin, APA CEO and Medical Director Saul Levin, MD, MPA--Washington
Dr. Saul Levin

“While the overall level of concern has dropped, still 4 in 10 parents are worried about how their children are doing, and a third are having issues with access to care,” Saul Levin, MD, CEO and medical director of the APA, said in the release.

“This is unacceptable and as a nation, we need to invest in the kind of systems that will ensure any parent who’s worried about their child has access to lifesaving treatment,” Dr. Levin added.
 

Workplace mental health

In addition, the poll showed employees often have a tough time getting mental health support from employers, or are hesitant to ask for help.

“What’s troubling about the results of this poll is that, even as the pandemic has continued and its mental health effects wear on, fewer employees are reporting that they have access to mental health services,” Dr. Pender said. 

“Workplaces need to ensure that they are paying attention to what their employees need, particularly now, and moving away from mental health benefits isn’t the right move,” she added.

About half (48%) of those polled said they can discuss mental health openly and honestly with their supervisor, down from 56% in 2021 and 62% in 2020.

Only about half (52%) said they feel comfortable using mental health services with their current employer, compared with 64% in 2021 and 67% in 2020.

In addition, fewer workers felt their employer is offering sufficient mental health resources and benefits. In 2022, 53% of workers thought resources and benefits were adequate, which was down from 65% in 2021 and 68% in 2020.

“It’s quite concerning to see that fewer people feel comfortable discussing mental health with a supervisor, at a time when people experiencing symptoms of anxiety, depression, and other conditions are on the rise and impact nearly every aspect of work, including productivity, performance, retention, and overall health care costs,” said Darcy Gruttadaro, JD, director of the APA Foundation’s Center for Workplace Mental Health.

“As rates of these conditions rise, we should see more employees knowing about available workplace mental health resources, not less,” Ms. Gruttadaro said.
 

Strong bipartisan support 

Perhaps unexpectedly, the poll shows strong support among Democrats, Republicans, and Independents for three APA-backed approaches to improve timely access to mental health care and treatment.

Specifically, about three-quarters of those polled supported making it easier to see a mental health professional via telehealth, allowing patients to receive mental health care through a primary care provider, and funding mental health care professionals to work in rural or urban communities that are traditionally underserved.

“We’re in a moment when mental health is a big part of the national conversation, and clearly political party doesn’t matter as much on this issue,” Dr. Pender noted. 

“It’s a rare thing in Washington these days to see such a resounding endorsement, but there is strong support for these practical workable solutions that mean more access to mental health care,” she said.

“What you see in this poll is agreement: It’s hard to access mental [health care] but we do have great solutions that could work across party lines,” Dr. Levin added.

“Many policy makers, in the administration and in Congress, are already putting these ideas into action, and they should feel encouraged that the public wants to see Congress act on them,” he said.

A version of this article first appeared on Medscape.com.

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