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A unique care model for comorbid depression, PTSD
“We know there are strains on the mental health care system, and sometimes something as simple as getting to see a psychiatrist can be incredibly challenging,” coinvestigator Zachary Zuschlag, MD, staff psychiatrist at the James A. Haley Veterans’ Hospital and assistant professor at the University of South Florida, both in Tampa, said in an interview.
“So, a model that encourages primary care doctors, together with consultation from us [psychiatrists] to effectively treat these patients in a more proactive way, is very beneficial,” Dr. Zuschlag said.
The findings were presented at the American Society of Clinical Psychopharmacology annual meeting.
Common bedfellows
Dr. Zuschlag noted that comorbid PTSD and depression is common, but it is often considered too complex to be managed in a primary care setting.
Although treating these patients can be challenging, Dr. Zuschlag, who also heads his Veterans Administration facility’s antidepressant monitoring program (ADM), said that when he started the program for this patient population, he used “a much more inclusive model and welcomed these patients even if they had co-occurring issues.”
“Anecdotally, we had seen that our patients with [depression and] co-occurring PTSD appeared to be doing as well as their peers without PTSD, and we just wanted to look at it more systematically,” he added.
The ADM program is specifically designed for psychopharmacologic management of depression and anxiety in the primary care setting. It involves an interdisciplinary team of RN care managers, consulting psychiatrists, psychologists, and primary care physicians. Patients in primary care clinics deemed likely to benefit from psychiatric medications can be enrolled and followed in the program.
The program consists of structured, protocol-based telephone contacts from the RN care managers at scheduled intervals, usually every 3-4 weeks, said Dr. Zuschlag.
During calls, information is collected via evidence-based mental health symptomatic assessment scales. The consulting psychiatrists use this and other information to help guide treatment and coordinate with patients’ primary care physicians to adjust the treatment plan, including medication changes and additional psychotherapy.
To determine the program’s efficacy the investigators retrospectively reviewed all patients enrolled in the ADM program during its first 10 months. Of the 433 program participants, 112 (26%) were identified with active PTSD symptoms at baseline. Another 43 patients had a prior diagnosis of PTSD.
Program completion rates for the cohort with PTSD did not differ from that of the cohort without PTSD.
Overall, mean improvements in depression and anxiety symptoms were evidenced by changes in Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Assessment-7 (GAD-7) scores of 44% and 43%, respectively.
No differences in mean reduction in symptoms of depression were observed when comparing those with no history of PTSD with those with any history of PTSD (–6.16 vs. –5.42; P = .3244) or with those with active PTSD symptoms (–6.16 vs. –5.54; P = .4543).
Similarly, for anxiety, a mean reduction of –5.61 on the GAD-7 score was observed for the cohort without PTSD, compared with –4.99 in the cohort with any history of PTSD and –5.35 in the cohort with active PTSD symptoms. Again, these differences were nonsignificant.
Dr. Zuschlag noted that the VA setting is unique, with a lot of resources available to conduct such a program as ADM.
“Care management programs that are multidisciplinary are very effective and, in our experience, those who have completed the program do exceptionally well. The patients love it because there is a lot of contact between them and their various care providers,” he said.
A model for other settings?
Commenting on the study, Nagy A. Youssef, MD, PhD, professor of psychiatry and director of clinical research at Ohio State University, Columbus, called the results “interesting.”
“Treating patients with comorbid mild to moderate depression and current or past PTSD within the primary care setting using a care management program could be a model for other VA hospitals as well as in non-VA settings,” said Dr. Youssef, who was not part of the study.
Dr. Youssef noted that not only was there no difference in symptomatic improvement between the depression-plus-PTSD and depression-only groups, but program completion rates did not differ.
This further emphasizes “the potential utility of this approach in initial patient treatment, especially with limited mental health resources and the need to help more patients,” he said.
Dr. Zuschlag and Dr. Youssef report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“We know there are strains on the mental health care system, and sometimes something as simple as getting to see a psychiatrist can be incredibly challenging,” coinvestigator Zachary Zuschlag, MD, staff psychiatrist at the James A. Haley Veterans’ Hospital and assistant professor at the University of South Florida, both in Tampa, said in an interview.
“So, a model that encourages primary care doctors, together with consultation from us [psychiatrists] to effectively treat these patients in a more proactive way, is very beneficial,” Dr. Zuschlag said.
The findings were presented at the American Society of Clinical Psychopharmacology annual meeting.
Common bedfellows
Dr. Zuschlag noted that comorbid PTSD and depression is common, but it is often considered too complex to be managed in a primary care setting.
Although treating these patients can be challenging, Dr. Zuschlag, who also heads his Veterans Administration facility’s antidepressant monitoring program (ADM), said that when he started the program for this patient population, he used “a much more inclusive model and welcomed these patients even if they had co-occurring issues.”
“Anecdotally, we had seen that our patients with [depression and] co-occurring PTSD appeared to be doing as well as their peers without PTSD, and we just wanted to look at it more systematically,” he added.
The ADM program is specifically designed for psychopharmacologic management of depression and anxiety in the primary care setting. It involves an interdisciplinary team of RN care managers, consulting psychiatrists, psychologists, and primary care physicians. Patients in primary care clinics deemed likely to benefit from psychiatric medications can be enrolled and followed in the program.
The program consists of structured, protocol-based telephone contacts from the RN care managers at scheduled intervals, usually every 3-4 weeks, said Dr. Zuschlag.
During calls, information is collected via evidence-based mental health symptomatic assessment scales. The consulting psychiatrists use this and other information to help guide treatment and coordinate with patients’ primary care physicians to adjust the treatment plan, including medication changes and additional psychotherapy.
To determine the program’s efficacy the investigators retrospectively reviewed all patients enrolled in the ADM program during its first 10 months. Of the 433 program participants, 112 (26%) were identified with active PTSD symptoms at baseline. Another 43 patients had a prior diagnosis of PTSD.
Program completion rates for the cohort with PTSD did not differ from that of the cohort without PTSD.
Overall, mean improvements in depression and anxiety symptoms were evidenced by changes in Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Assessment-7 (GAD-7) scores of 44% and 43%, respectively.
No differences in mean reduction in symptoms of depression were observed when comparing those with no history of PTSD with those with any history of PTSD (–6.16 vs. –5.42; P = .3244) or with those with active PTSD symptoms (–6.16 vs. –5.54; P = .4543).
Similarly, for anxiety, a mean reduction of –5.61 on the GAD-7 score was observed for the cohort without PTSD, compared with –4.99 in the cohort with any history of PTSD and –5.35 in the cohort with active PTSD symptoms. Again, these differences were nonsignificant.
Dr. Zuschlag noted that the VA setting is unique, with a lot of resources available to conduct such a program as ADM.
“Care management programs that are multidisciplinary are very effective and, in our experience, those who have completed the program do exceptionally well. The patients love it because there is a lot of contact between them and their various care providers,” he said.
A model for other settings?
Commenting on the study, Nagy A. Youssef, MD, PhD, professor of psychiatry and director of clinical research at Ohio State University, Columbus, called the results “interesting.”
“Treating patients with comorbid mild to moderate depression and current or past PTSD within the primary care setting using a care management program could be a model for other VA hospitals as well as in non-VA settings,” said Dr. Youssef, who was not part of the study.
Dr. Youssef noted that not only was there no difference in symptomatic improvement between the depression-plus-PTSD and depression-only groups, but program completion rates did not differ.
This further emphasizes “the potential utility of this approach in initial patient treatment, especially with limited mental health resources and the need to help more patients,” he said.
Dr. Zuschlag and Dr. Youssef report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“We know there are strains on the mental health care system, and sometimes something as simple as getting to see a psychiatrist can be incredibly challenging,” coinvestigator Zachary Zuschlag, MD, staff psychiatrist at the James A. Haley Veterans’ Hospital and assistant professor at the University of South Florida, both in Tampa, said in an interview.
“So, a model that encourages primary care doctors, together with consultation from us [psychiatrists] to effectively treat these patients in a more proactive way, is very beneficial,” Dr. Zuschlag said.
The findings were presented at the American Society of Clinical Psychopharmacology annual meeting.
Common bedfellows
Dr. Zuschlag noted that comorbid PTSD and depression is common, but it is often considered too complex to be managed in a primary care setting.
Although treating these patients can be challenging, Dr. Zuschlag, who also heads his Veterans Administration facility’s antidepressant monitoring program (ADM), said that when he started the program for this patient population, he used “a much more inclusive model and welcomed these patients even if they had co-occurring issues.”
“Anecdotally, we had seen that our patients with [depression and] co-occurring PTSD appeared to be doing as well as their peers without PTSD, and we just wanted to look at it more systematically,” he added.
The ADM program is specifically designed for psychopharmacologic management of depression and anxiety in the primary care setting. It involves an interdisciplinary team of RN care managers, consulting psychiatrists, psychologists, and primary care physicians. Patients in primary care clinics deemed likely to benefit from psychiatric medications can be enrolled and followed in the program.
The program consists of structured, protocol-based telephone contacts from the RN care managers at scheduled intervals, usually every 3-4 weeks, said Dr. Zuschlag.
During calls, information is collected via evidence-based mental health symptomatic assessment scales. The consulting psychiatrists use this and other information to help guide treatment and coordinate with patients’ primary care physicians to adjust the treatment plan, including medication changes and additional psychotherapy.
To determine the program’s efficacy the investigators retrospectively reviewed all patients enrolled in the ADM program during its first 10 months. Of the 433 program participants, 112 (26%) were identified with active PTSD symptoms at baseline. Another 43 patients had a prior diagnosis of PTSD.
Program completion rates for the cohort with PTSD did not differ from that of the cohort without PTSD.
Overall, mean improvements in depression and anxiety symptoms were evidenced by changes in Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Assessment-7 (GAD-7) scores of 44% and 43%, respectively.
No differences in mean reduction in symptoms of depression were observed when comparing those with no history of PTSD with those with any history of PTSD (–6.16 vs. –5.42; P = .3244) or with those with active PTSD symptoms (–6.16 vs. –5.54; P = .4543).
Similarly, for anxiety, a mean reduction of –5.61 on the GAD-7 score was observed for the cohort without PTSD, compared with –4.99 in the cohort with any history of PTSD and –5.35 in the cohort with active PTSD symptoms. Again, these differences were nonsignificant.
Dr. Zuschlag noted that the VA setting is unique, with a lot of resources available to conduct such a program as ADM.
“Care management programs that are multidisciplinary are very effective and, in our experience, those who have completed the program do exceptionally well. The patients love it because there is a lot of contact between them and their various care providers,” he said.
A model for other settings?
Commenting on the study, Nagy A. Youssef, MD, PhD, professor of psychiatry and director of clinical research at Ohio State University, Columbus, called the results “interesting.”
“Treating patients with comorbid mild to moderate depression and current or past PTSD within the primary care setting using a care management program could be a model for other VA hospitals as well as in non-VA settings,” said Dr. Youssef, who was not part of the study.
Dr. Youssef noted that not only was there no difference in symptomatic improvement between the depression-plus-PTSD and depression-only groups, but program completion rates did not differ.
This further emphasizes “the potential utility of this approach in initial patient treatment, especially with limited mental health resources and the need to help more patients,” he said.
Dr. Zuschlag and Dr. Youssef report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ASCP 2022
ECT may reduce all-cause mortality in major depression
In an analysis of data from a large database of inpatients across the United States, use of ECT for those with resistant MDD was associated with significantly lower in-hospital mortality compared with those who did not receive ECT.
This held true even after the researchers controlled for demographics and loss of function due to comorbid medical conditions.
“I think the risks of ECT are far less than the benefits in this population,” coinvestigator Nagy A. Youssef, MD, PhD, professor of psychiatry and director of clinical research, The Ohio State University, Columbus, told this news organization.
“My hope is that providers will not be afraid to refer appropriate cases for ECT. If meds and other therapeutics are not working, you should start discussing ECT as a second or third line,” he said.
The findings were presented at the American Society of Clinical Psychopharmacology annual meeting.
Lower mortality
Dr. Youssef, a brain stimulation researcher who uses ECT in his clinical practice, said that in his experience, it is a highly effective therapy for resistant depression.
“I see great responses in patients who have tried everything else. Most of the time, it works very well, and results are very rewarding.”
For the study, the investigators used a large, national insurance claims database that included 949,394 adult inpatients with MDD across the United States from 2012 to 2014. The cohort represented over 4,000 hospitals across the country.
The investigators used logistic regression to determine the odds ratio for in-hospital all-cause mortality for the 25,535 MDD patients who were treated with ECT in comparison with 923,859 patients with MDD who were not treated with ECT.
Results showed that ECT use was significantly higher among older patients (mean age, 56.9 years), women (64%), and White patients (86.9%). In addition, patients in the ECT group were physically sicker than were their peers in the non-ECT group.
A higher proportion of patients in the ECT group in comparison with the non-ECT group had experienced major loss of physical function (37% vs. 5%, respectively) and extreme loss of physical function (63% vs. 0.2%).
“By loss of function, I mean the degree of impairment caused by medical disease,” said Dr. Youssef.
He added that patients with MDD are more likely to care less for their health and do things that are not good for their well-being, such as drinking alcohol or using drugs, and are less likely to adhere to prescribed medication regimens or seek medical attention for physical illness.
“Also, there is probably a biological component where depression, by dysregulation of the hypothalamus and pituitary regions of the brain, can increase the likelihood of physical illness or disease,” Dr. Youssef said.
After adjusting for demographics and extreme loss of function because of medical conditions, the investigators found that in-hospital mortality was significantly lower in the ECT group (odds ratio [OR], 0.05; 95% confidence interval [CI], 0.02-0.11; P < .001).
In-hospital mortality was numerically but not statistically significantly lower in the ECT group (OR, 0.7; 95% CI, 0.41-1.50; P < .47) when adjusted for demographics and major loss of function.
“While this was not statistically significant with marked loss of function, it is clinically important and meaningful. With extreme loss of function, the decrease in mortality was statistically significant,” Dr. Youssef noted.
Designations of extreme and major loss of function were derived from ICD codes.
“This is a complex grading system that takes into account how sick the patient is and includes medical disease severity and comorbidities assessed by the clinician,” he said.
A lifesaving treatment
Commenting on the study, Jair C. Soares, MD, PhD, professor and chair, Pat Rutherford Chair in Psychiatry, UT Houston Medical School, Texas, said, “These are interesting results in a very large national sample suggesting some potential benefits of ECT.
“For the most severely ill patients with major depression who do not respond to currently available medications, ECT is still the most efficacious treatment and indeed a lifesaving treatment modality for many patients,” said Dr. Soares, who was not part of the study.
He noted that ECT is not right for everyone, but “as administered these days, with careful patient selection, it is indeed a safe treatment that can save many lives,” Dr. Soares said.
Dr. Youssef reports a financial relationship with Mecta. Dr. Soares reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In an analysis of data from a large database of inpatients across the United States, use of ECT for those with resistant MDD was associated with significantly lower in-hospital mortality compared with those who did not receive ECT.
This held true even after the researchers controlled for demographics and loss of function due to comorbid medical conditions.
“I think the risks of ECT are far less than the benefits in this population,” coinvestigator Nagy A. Youssef, MD, PhD, professor of psychiatry and director of clinical research, The Ohio State University, Columbus, told this news organization.
“My hope is that providers will not be afraid to refer appropriate cases for ECT. If meds and other therapeutics are not working, you should start discussing ECT as a second or third line,” he said.
The findings were presented at the American Society of Clinical Psychopharmacology annual meeting.
Lower mortality
Dr. Youssef, a brain stimulation researcher who uses ECT in his clinical practice, said that in his experience, it is a highly effective therapy for resistant depression.
“I see great responses in patients who have tried everything else. Most of the time, it works very well, and results are very rewarding.”
For the study, the investigators used a large, national insurance claims database that included 949,394 adult inpatients with MDD across the United States from 2012 to 2014. The cohort represented over 4,000 hospitals across the country.
The investigators used logistic regression to determine the odds ratio for in-hospital all-cause mortality for the 25,535 MDD patients who were treated with ECT in comparison with 923,859 patients with MDD who were not treated with ECT.
Results showed that ECT use was significantly higher among older patients (mean age, 56.9 years), women (64%), and White patients (86.9%). In addition, patients in the ECT group were physically sicker than were their peers in the non-ECT group.
A higher proportion of patients in the ECT group in comparison with the non-ECT group had experienced major loss of physical function (37% vs. 5%, respectively) and extreme loss of physical function (63% vs. 0.2%).
“By loss of function, I mean the degree of impairment caused by medical disease,” said Dr. Youssef.
He added that patients with MDD are more likely to care less for their health and do things that are not good for their well-being, such as drinking alcohol or using drugs, and are less likely to adhere to prescribed medication regimens or seek medical attention for physical illness.
“Also, there is probably a biological component where depression, by dysregulation of the hypothalamus and pituitary regions of the brain, can increase the likelihood of physical illness or disease,” Dr. Youssef said.
After adjusting for demographics and extreme loss of function because of medical conditions, the investigators found that in-hospital mortality was significantly lower in the ECT group (odds ratio [OR], 0.05; 95% confidence interval [CI], 0.02-0.11; P < .001).
In-hospital mortality was numerically but not statistically significantly lower in the ECT group (OR, 0.7; 95% CI, 0.41-1.50; P < .47) when adjusted for demographics and major loss of function.
“While this was not statistically significant with marked loss of function, it is clinically important and meaningful. With extreme loss of function, the decrease in mortality was statistically significant,” Dr. Youssef noted.
Designations of extreme and major loss of function were derived from ICD codes.
“This is a complex grading system that takes into account how sick the patient is and includes medical disease severity and comorbidities assessed by the clinician,” he said.
A lifesaving treatment
Commenting on the study, Jair C. Soares, MD, PhD, professor and chair, Pat Rutherford Chair in Psychiatry, UT Houston Medical School, Texas, said, “These are interesting results in a very large national sample suggesting some potential benefits of ECT.
“For the most severely ill patients with major depression who do not respond to currently available medications, ECT is still the most efficacious treatment and indeed a lifesaving treatment modality for many patients,” said Dr. Soares, who was not part of the study.
He noted that ECT is not right for everyone, but “as administered these days, with careful patient selection, it is indeed a safe treatment that can save many lives,” Dr. Soares said.
Dr. Youssef reports a financial relationship with Mecta. Dr. Soares reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In an analysis of data from a large database of inpatients across the United States, use of ECT for those with resistant MDD was associated with significantly lower in-hospital mortality compared with those who did not receive ECT.
This held true even after the researchers controlled for demographics and loss of function due to comorbid medical conditions.
“I think the risks of ECT are far less than the benefits in this population,” coinvestigator Nagy A. Youssef, MD, PhD, professor of psychiatry and director of clinical research, The Ohio State University, Columbus, told this news organization.
“My hope is that providers will not be afraid to refer appropriate cases for ECT. If meds and other therapeutics are not working, you should start discussing ECT as a second or third line,” he said.
The findings were presented at the American Society of Clinical Psychopharmacology annual meeting.
Lower mortality
Dr. Youssef, a brain stimulation researcher who uses ECT in his clinical practice, said that in his experience, it is a highly effective therapy for resistant depression.
“I see great responses in patients who have tried everything else. Most of the time, it works very well, and results are very rewarding.”
For the study, the investigators used a large, national insurance claims database that included 949,394 adult inpatients with MDD across the United States from 2012 to 2014. The cohort represented over 4,000 hospitals across the country.
The investigators used logistic regression to determine the odds ratio for in-hospital all-cause mortality for the 25,535 MDD patients who were treated with ECT in comparison with 923,859 patients with MDD who were not treated with ECT.
Results showed that ECT use was significantly higher among older patients (mean age, 56.9 years), women (64%), and White patients (86.9%). In addition, patients in the ECT group were physically sicker than were their peers in the non-ECT group.
A higher proportion of patients in the ECT group in comparison with the non-ECT group had experienced major loss of physical function (37% vs. 5%, respectively) and extreme loss of physical function (63% vs. 0.2%).
“By loss of function, I mean the degree of impairment caused by medical disease,” said Dr. Youssef.
He added that patients with MDD are more likely to care less for their health and do things that are not good for their well-being, such as drinking alcohol or using drugs, and are less likely to adhere to prescribed medication regimens or seek medical attention for physical illness.
“Also, there is probably a biological component where depression, by dysregulation of the hypothalamus and pituitary regions of the brain, can increase the likelihood of physical illness or disease,” Dr. Youssef said.
After adjusting for demographics and extreme loss of function because of medical conditions, the investigators found that in-hospital mortality was significantly lower in the ECT group (odds ratio [OR], 0.05; 95% confidence interval [CI], 0.02-0.11; P < .001).
In-hospital mortality was numerically but not statistically significantly lower in the ECT group (OR, 0.7; 95% CI, 0.41-1.50; P < .47) when adjusted for demographics and major loss of function.
“While this was not statistically significant with marked loss of function, it is clinically important and meaningful. With extreme loss of function, the decrease in mortality was statistically significant,” Dr. Youssef noted.
Designations of extreme and major loss of function were derived from ICD codes.
“This is a complex grading system that takes into account how sick the patient is and includes medical disease severity and comorbidities assessed by the clinician,” he said.
A lifesaving treatment
Commenting on the study, Jair C. Soares, MD, PhD, professor and chair, Pat Rutherford Chair in Psychiatry, UT Houston Medical School, Texas, said, “These are interesting results in a very large national sample suggesting some potential benefits of ECT.
“For the most severely ill patients with major depression who do not respond to currently available medications, ECT is still the most efficacious treatment and indeed a lifesaving treatment modality for many patients,” said Dr. Soares, who was not part of the study.
He noted that ECT is not right for everyone, but “as administered these days, with careful patient selection, it is indeed a safe treatment that can save many lives,” Dr. Soares said.
Dr. Youssef reports a financial relationship with Mecta. Dr. Soares reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ASCP 2022
Novel drug ‘promising’ for concomitant depression, insomnia
In a randomized, placebo-controlled, adaptive dose–finding study conducted in more than 200 patients with MDD, those with more severe insomnia at baseline had a greater improvement in depressive symptoms versus those with less severe insomnia.
“As seltorexant is an orexin receptor antagonist, it is related to other medications that are marketed as sleeping pills, so it was important to show that its antidepressant efficacy was actually caused by improved sleep,” coinvestigator Michael E. Thase, MD, professor of psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, told this news organization.
“This novel antidepressant may well turn out to be a treatment of choice for depressed patients with insomnia,” said Dr. Thase, who is also a member of the medical and research staff of the Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center.
The findings were presented at the American Society of Clinical Psychopharmacology annual meeting.
Clinically meaningful?
In an earlier exploratory study, seltorexant showed antidepressant and sleep-promoting effects in patients with MDD. In a phase 2b study, a 20-mg dose of the drug showed clinically meaningful improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score after 6 weeks of treatment.
In the current analysis, the investigators evaluated the effect of seltorexant in improving depressive symptoms beyond sleep-related improvement in patients with MDD, using the MADRS-WOSI (MADRS without the sleep item).
They also used the six-item core MADRS subscale, which excludes sleep, anxiety, and appetite items.
The 283 participants were randomly assigned 3:3:1 to receive seltorexant 10 mg or 20 mg or placebo once daily. They were also stratified into two groups according to the severity of their insomnia: those with a baseline Insomnia Severity Index [ISI] score of 15 or higher (58%) and those with a baseline ISI score of less than 15 (42%).
Results showed that the group receiving the 20-mg/day dose of seltorexant (n = 61 patients) obtained a statistically and clinically meaningful response, compared with the placebo group (n = 137 patients) after removing the insomnia and other “not core items” of the MADRS. The effect was clearest among those with high insomnia ratings.
Improvement in the MADRS-WOSI score was also observed in the seltorexant 20-mg group at week 3 and week 6, compared with the placebo group.
The LSM average distance
The least squares mean (LSM) average difference between the treatment and placebo groups in the MADRS-WOSI score at week 3 was −3.8 (90% confidence interval, −5.98 to −1.57; P = .005).
At week 6, the LSM between the groups in the MADRS-WOSI score was −2.5 (90% CI, −5.24 to 0.15; P = .12).
The results were consistent with improvement in the MADRS total score. At week 3, the LSM in the MADRS total score was -4.5 (90% CI, -6.96 to -2.07; P = .003) and, at week 6, it was -3.1 (90% CI, -6.13 to -0.16; P = .083).
Seltorexant 20 mg was especially effective in patients who had more severe insomnia.
Commenting on the study, Nagy Youssef, MD, PhD, professor of psychiatry, The Ohio State University Wexner Medical Center, Columbus, said this was “a well-designed study examining a promising compound.”
“Especially if replicated, this study shows the promise of this molecule for this patient population,” said Dr. Youssef, who was not involved with the research.
The study was funded by Janssen Pharmaceutical of Johnson & Johnson. Dr. Thase reports financial relationships with numerous companies. Dr. Youssef reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a randomized, placebo-controlled, adaptive dose–finding study conducted in more than 200 patients with MDD, those with more severe insomnia at baseline had a greater improvement in depressive symptoms versus those with less severe insomnia.
“As seltorexant is an orexin receptor antagonist, it is related to other medications that are marketed as sleeping pills, so it was important to show that its antidepressant efficacy was actually caused by improved sleep,” coinvestigator Michael E. Thase, MD, professor of psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, told this news organization.
“This novel antidepressant may well turn out to be a treatment of choice for depressed patients with insomnia,” said Dr. Thase, who is also a member of the medical and research staff of the Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center.
The findings were presented at the American Society of Clinical Psychopharmacology annual meeting.
Clinically meaningful?
In an earlier exploratory study, seltorexant showed antidepressant and sleep-promoting effects in patients with MDD. In a phase 2b study, a 20-mg dose of the drug showed clinically meaningful improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score after 6 weeks of treatment.
In the current analysis, the investigators evaluated the effect of seltorexant in improving depressive symptoms beyond sleep-related improvement in patients with MDD, using the MADRS-WOSI (MADRS without the sleep item).
They also used the six-item core MADRS subscale, which excludes sleep, anxiety, and appetite items.
The 283 participants were randomly assigned 3:3:1 to receive seltorexant 10 mg or 20 mg or placebo once daily. They were also stratified into two groups according to the severity of their insomnia: those with a baseline Insomnia Severity Index [ISI] score of 15 or higher (58%) and those with a baseline ISI score of less than 15 (42%).
Results showed that the group receiving the 20-mg/day dose of seltorexant (n = 61 patients) obtained a statistically and clinically meaningful response, compared with the placebo group (n = 137 patients) after removing the insomnia and other “not core items” of the MADRS. The effect was clearest among those with high insomnia ratings.
Improvement in the MADRS-WOSI score was also observed in the seltorexant 20-mg group at week 3 and week 6, compared with the placebo group.
The LSM average distance
The least squares mean (LSM) average difference between the treatment and placebo groups in the MADRS-WOSI score at week 3 was −3.8 (90% confidence interval, −5.98 to −1.57; P = .005).
At week 6, the LSM between the groups in the MADRS-WOSI score was −2.5 (90% CI, −5.24 to 0.15; P = .12).
The results were consistent with improvement in the MADRS total score. At week 3, the LSM in the MADRS total score was -4.5 (90% CI, -6.96 to -2.07; P = .003) and, at week 6, it was -3.1 (90% CI, -6.13 to -0.16; P = .083).
Seltorexant 20 mg was especially effective in patients who had more severe insomnia.
Commenting on the study, Nagy Youssef, MD, PhD, professor of psychiatry, The Ohio State University Wexner Medical Center, Columbus, said this was “a well-designed study examining a promising compound.”
“Especially if replicated, this study shows the promise of this molecule for this patient population,” said Dr. Youssef, who was not involved with the research.
The study was funded by Janssen Pharmaceutical of Johnson & Johnson. Dr. Thase reports financial relationships with numerous companies. Dr. Youssef reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a randomized, placebo-controlled, adaptive dose–finding study conducted in more than 200 patients with MDD, those with more severe insomnia at baseline had a greater improvement in depressive symptoms versus those with less severe insomnia.
“As seltorexant is an orexin receptor antagonist, it is related to other medications that are marketed as sleeping pills, so it was important to show that its antidepressant efficacy was actually caused by improved sleep,” coinvestigator Michael E. Thase, MD, professor of psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, told this news organization.
“This novel antidepressant may well turn out to be a treatment of choice for depressed patients with insomnia,” said Dr. Thase, who is also a member of the medical and research staff of the Corporal Michael J. Crescenz Department of Veterans Affairs Medical Center.
The findings were presented at the American Society of Clinical Psychopharmacology annual meeting.
Clinically meaningful?
In an earlier exploratory study, seltorexant showed antidepressant and sleep-promoting effects in patients with MDD. In a phase 2b study, a 20-mg dose of the drug showed clinically meaningful improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score after 6 weeks of treatment.
In the current analysis, the investigators evaluated the effect of seltorexant in improving depressive symptoms beyond sleep-related improvement in patients with MDD, using the MADRS-WOSI (MADRS without the sleep item).
They also used the six-item core MADRS subscale, which excludes sleep, anxiety, and appetite items.
The 283 participants were randomly assigned 3:3:1 to receive seltorexant 10 mg or 20 mg or placebo once daily. They were also stratified into two groups according to the severity of their insomnia: those with a baseline Insomnia Severity Index [ISI] score of 15 or higher (58%) and those with a baseline ISI score of less than 15 (42%).
Results showed that the group receiving the 20-mg/day dose of seltorexant (n = 61 patients) obtained a statistically and clinically meaningful response, compared with the placebo group (n = 137 patients) after removing the insomnia and other “not core items” of the MADRS. The effect was clearest among those with high insomnia ratings.
Improvement in the MADRS-WOSI score was also observed in the seltorexant 20-mg group at week 3 and week 6, compared with the placebo group.
The LSM average distance
The least squares mean (LSM) average difference between the treatment and placebo groups in the MADRS-WOSI score at week 3 was −3.8 (90% confidence interval, −5.98 to −1.57; P = .005).
At week 6, the LSM between the groups in the MADRS-WOSI score was −2.5 (90% CI, −5.24 to 0.15; P = .12).
The results were consistent with improvement in the MADRS total score. At week 3, the LSM in the MADRS total score was -4.5 (90% CI, -6.96 to -2.07; P = .003) and, at week 6, it was -3.1 (90% CI, -6.13 to -0.16; P = .083).
Seltorexant 20 mg was especially effective in patients who had more severe insomnia.
Commenting on the study, Nagy Youssef, MD, PhD, professor of psychiatry, The Ohio State University Wexner Medical Center, Columbus, said this was “a well-designed study examining a promising compound.”
“Especially if replicated, this study shows the promise of this molecule for this patient population,” said Dr. Youssef, who was not involved with the research.
The study was funded by Janssen Pharmaceutical of Johnson & Johnson. Dr. Thase reports financial relationships with numerous companies. Dr. Youssef reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ASCP 2022
Social activities may offset psychosis risk in poor communities
, new research suggests.
A study of more than 170 young participants showed reduced hippocampal volume in those living in poor neighborhoods who had low social engagement versus their peers with greater community engagement.
“These findings demonstrate the importance of considering broader environmental influences and indices of social engagement when conceptualizing adversity and potential interventions for individuals at clinical high risk for psychosis,” co-investigator Benson Ku, MD, a postdoctoral fellow and psychiatry resident at Emory University School of Medicine, Atlanta, told this news organization.
The results were presented at the virtual American Society of Clinical Psychopharmacology annual meeting.
A personal connection
It’s well known that growing up in low-income housing is associated with lower hippocampal volume and an increased risk for schizophrenia, said Dr. Ku.
“The inverse relationship between poverty and hippocampal gray matter volume has [also] been shown to be mediated by social stress, which can include things like lack of parental caregiving and stressful life events,” he added.
Dr. Ku himself grew up in a socioeconomically disadvantaged family in Queens, New York, and he said he had initially performed poorly in school. His early experiences have helped inform his clinical and research interests in the social determinants of mental health.
“I found community support in the Boys’ Club of New York and a local Magic Shop near where I lived, which helped me thrive and become the successful man I am today. I have also heard from my patients how their living conditions and neighborhood have significantly impacted their mental health,” Dr. Ku said.
“A more in-depth understanding of the social determinants of mental health has helped build rapport and empathy with my patients,” he added.
To explore the association between neighborhood poverty, social engagement, and hippocampal volume in youth at high risk for psychosis, the researchers analyzed data from the North American Prodrome Longitudinal Study Phase 2, a multisite consortium.
The researchers recruited and followed up with help-seeking adolescents and young adults from diverse neighborhoods. The analysis included 174 youth, ages 12-33 years, at high clinical risk for psychosis.
Hippocampal volume was assessed using structural MRI. Neighborhood poverty was defined as the percentage of residents with an annual income below the poverty level in the past year.
Social engagement was derived from the desirable events subscale items of the Life Events Scale. These activities included involvement in a church or synagogue; participation in a club, neighborhood, or other organization; taking a vacation; engaging in a hobby, sport, craft, or recreational activity; acquiring a pet; or making new friends.
Lower hippocampal volume
Results showed neighborhood poverty was associated with reduced hippocampal volume, even after controlling for several confounders, including race/ethnicity, family history of mental illnesses, household poverty, educational level, and stressful life events.
Among the 77 participants with lower social engagement, which was defined as three or fewer social activities, neighborhood poverty was associated with reduced hippocampal volume.
However, in the 97 participants who reported greater social engagement, which was defined as four or more social activities, neighborhood poverty was not significantly associated with hippocampal volume.
“It is possible that social engagement may mitigate the deleterious effects of neighborhood poverty on brain morphology, which may inform interventions offered to individuals from disadvantaged neighborhoods,” Dr. Ku said.
“If replication of the relationships between neighborhood poverty, hippocampal volume, and social engagement is established in other populations in longitudinal studies, then targeted interventions at the community level and increased social engagement may potentially play a major role in disease prevention among at-risk youth,” he said.
Dr. Ku noted social engagement might look different in urban versus rural settings.
“In urban areas, it might mean friends, clubs, neighborhood organizations, etc. In rural areas, it might mean family, pets, crafts, etc. The level of social engagement may also depend on neighborhood characteristics, and more research would be needed to better understand how geographic area characteristics – remote, rural, urban – affects social engagement,” he said.
Interesting, innovative
Nagy Youssef, MD, PhD, director of clinical research and professor of psychiatry, Ohio State University College of Medicine, Columbus, said the study suggests “social engagement may reduce the negative effect of poverty in this population, and if replicated in a larger study, could assist and be a part of the early intervention and prevention in psychosis.”
Overall, “this is an interesting and innovative study that has important medical and social implications and is a good step toward helping us understand these relationships and mitigate and prevent negative consequences, as best as possible, in this population,” said Dr. Youssef, who was not part of the research.
The analysis was supported by a grant from the National Institute of Mental Health to the North American Prodrome Longitudinal Study. Dr. Ku and Dr. Youssef report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
A study of more than 170 young participants showed reduced hippocampal volume in those living in poor neighborhoods who had low social engagement versus their peers with greater community engagement.
“These findings demonstrate the importance of considering broader environmental influences and indices of social engagement when conceptualizing adversity and potential interventions for individuals at clinical high risk for psychosis,” co-investigator Benson Ku, MD, a postdoctoral fellow and psychiatry resident at Emory University School of Medicine, Atlanta, told this news organization.
The results were presented at the virtual American Society of Clinical Psychopharmacology annual meeting.
A personal connection
It’s well known that growing up in low-income housing is associated with lower hippocampal volume and an increased risk for schizophrenia, said Dr. Ku.
“The inverse relationship between poverty and hippocampal gray matter volume has [also] been shown to be mediated by social stress, which can include things like lack of parental caregiving and stressful life events,” he added.
Dr. Ku himself grew up in a socioeconomically disadvantaged family in Queens, New York, and he said he had initially performed poorly in school. His early experiences have helped inform his clinical and research interests in the social determinants of mental health.
“I found community support in the Boys’ Club of New York and a local Magic Shop near where I lived, which helped me thrive and become the successful man I am today. I have also heard from my patients how their living conditions and neighborhood have significantly impacted their mental health,” Dr. Ku said.
“A more in-depth understanding of the social determinants of mental health has helped build rapport and empathy with my patients,” he added.
To explore the association between neighborhood poverty, social engagement, and hippocampal volume in youth at high risk for psychosis, the researchers analyzed data from the North American Prodrome Longitudinal Study Phase 2, a multisite consortium.
The researchers recruited and followed up with help-seeking adolescents and young adults from diverse neighborhoods. The analysis included 174 youth, ages 12-33 years, at high clinical risk for psychosis.
Hippocampal volume was assessed using structural MRI. Neighborhood poverty was defined as the percentage of residents with an annual income below the poverty level in the past year.
Social engagement was derived from the desirable events subscale items of the Life Events Scale. These activities included involvement in a church or synagogue; participation in a club, neighborhood, or other organization; taking a vacation; engaging in a hobby, sport, craft, or recreational activity; acquiring a pet; or making new friends.
Lower hippocampal volume
Results showed neighborhood poverty was associated with reduced hippocampal volume, even after controlling for several confounders, including race/ethnicity, family history of mental illnesses, household poverty, educational level, and stressful life events.
Among the 77 participants with lower social engagement, which was defined as three or fewer social activities, neighborhood poverty was associated with reduced hippocampal volume.
However, in the 97 participants who reported greater social engagement, which was defined as four or more social activities, neighborhood poverty was not significantly associated with hippocampal volume.
“It is possible that social engagement may mitigate the deleterious effects of neighborhood poverty on brain morphology, which may inform interventions offered to individuals from disadvantaged neighborhoods,” Dr. Ku said.
“If replication of the relationships between neighborhood poverty, hippocampal volume, and social engagement is established in other populations in longitudinal studies, then targeted interventions at the community level and increased social engagement may potentially play a major role in disease prevention among at-risk youth,” he said.
Dr. Ku noted social engagement might look different in urban versus rural settings.
“In urban areas, it might mean friends, clubs, neighborhood organizations, etc. In rural areas, it might mean family, pets, crafts, etc. The level of social engagement may also depend on neighborhood characteristics, and more research would be needed to better understand how geographic area characteristics – remote, rural, urban – affects social engagement,” he said.
Interesting, innovative
Nagy Youssef, MD, PhD, director of clinical research and professor of psychiatry, Ohio State University College of Medicine, Columbus, said the study suggests “social engagement may reduce the negative effect of poverty in this population, and if replicated in a larger study, could assist and be a part of the early intervention and prevention in psychosis.”
Overall, “this is an interesting and innovative study that has important medical and social implications and is a good step toward helping us understand these relationships and mitigate and prevent negative consequences, as best as possible, in this population,” said Dr. Youssef, who was not part of the research.
The analysis was supported by a grant from the National Institute of Mental Health to the North American Prodrome Longitudinal Study. Dr. Ku and Dr. Youssef report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
A study of more than 170 young participants showed reduced hippocampal volume in those living in poor neighborhoods who had low social engagement versus their peers with greater community engagement.
“These findings demonstrate the importance of considering broader environmental influences and indices of social engagement when conceptualizing adversity and potential interventions for individuals at clinical high risk for psychosis,” co-investigator Benson Ku, MD, a postdoctoral fellow and psychiatry resident at Emory University School of Medicine, Atlanta, told this news organization.
The results were presented at the virtual American Society of Clinical Psychopharmacology annual meeting.
A personal connection
It’s well known that growing up in low-income housing is associated with lower hippocampal volume and an increased risk for schizophrenia, said Dr. Ku.
“The inverse relationship between poverty and hippocampal gray matter volume has [also] been shown to be mediated by social stress, which can include things like lack of parental caregiving and stressful life events,” he added.
Dr. Ku himself grew up in a socioeconomically disadvantaged family in Queens, New York, and he said he had initially performed poorly in school. His early experiences have helped inform his clinical and research interests in the social determinants of mental health.
“I found community support in the Boys’ Club of New York and a local Magic Shop near where I lived, which helped me thrive and become the successful man I am today. I have also heard from my patients how their living conditions and neighborhood have significantly impacted their mental health,” Dr. Ku said.
“A more in-depth understanding of the social determinants of mental health has helped build rapport and empathy with my patients,” he added.
To explore the association between neighborhood poverty, social engagement, and hippocampal volume in youth at high risk for psychosis, the researchers analyzed data from the North American Prodrome Longitudinal Study Phase 2, a multisite consortium.
The researchers recruited and followed up with help-seeking adolescents and young adults from diverse neighborhoods. The analysis included 174 youth, ages 12-33 years, at high clinical risk for psychosis.
Hippocampal volume was assessed using structural MRI. Neighborhood poverty was defined as the percentage of residents with an annual income below the poverty level in the past year.
Social engagement was derived from the desirable events subscale items of the Life Events Scale. These activities included involvement in a church or synagogue; participation in a club, neighborhood, or other organization; taking a vacation; engaging in a hobby, sport, craft, or recreational activity; acquiring a pet; or making new friends.
Lower hippocampal volume
Results showed neighborhood poverty was associated with reduced hippocampal volume, even after controlling for several confounders, including race/ethnicity, family history of mental illnesses, household poverty, educational level, and stressful life events.
Among the 77 participants with lower social engagement, which was defined as three or fewer social activities, neighborhood poverty was associated with reduced hippocampal volume.
However, in the 97 participants who reported greater social engagement, which was defined as four or more social activities, neighborhood poverty was not significantly associated with hippocampal volume.
“It is possible that social engagement may mitigate the deleterious effects of neighborhood poverty on brain morphology, which may inform interventions offered to individuals from disadvantaged neighborhoods,” Dr. Ku said.
“If replication of the relationships between neighborhood poverty, hippocampal volume, and social engagement is established in other populations in longitudinal studies, then targeted interventions at the community level and increased social engagement may potentially play a major role in disease prevention among at-risk youth,” he said.
Dr. Ku noted social engagement might look different in urban versus rural settings.
“In urban areas, it might mean friends, clubs, neighborhood organizations, etc. In rural areas, it might mean family, pets, crafts, etc. The level of social engagement may also depend on neighborhood characteristics, and more research would be needed to better understand how geographic area characteristics – remote, rural, urban – affects social engagement,” he said.
Interesting, innovative
Nagy Youssef, MD, PhD, director of clinical research and professor of psychiatry, Ohio State University College of Medicine, Columbus, said the study suggests “social engagement may reduce the negative effect of poverty in this population, and if replicated in a larger study, could assist and be a part of the early intervention and prevention in psychosis.”
Overall, “this is an interesting and innovative study that has important medical and social implications and is a good step toward helping us understand these relationships and mitigate and prevent negative consequences, as best as possible, in this population,” said Dr. Youssef, who was not part of the research.
The analysis was supported by a grant from the National Institute of Mental Health to the North American Prodrome Longitudinal Study. Dr. Ku and Dr. Youssef report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ASCP 2022
At-home vagus nerve stimulation promising for postpartum depression
At-home, noninvasive auricular vagus nerve stimulation (aVNS) therapy is well-tolerated and associated with a significant reduction in postpartum depressive and anxiety symptoms, new research suggests.
In a small proof-of-concept pilot study of 25 women with postpartum depression receiving 6 weeks of daily aVNS treatment, results showed that 74% achieved response and 61% achieved remission, as shown in reduced scores on the Hamilton Rating Scale for Depression (HAM-D17).
Although invasive electrical stimulation of the vagus nerve was approved by the U.S. Food and Drug Administration for treatment-resistant depression in 2005, it involves risk for implantation, infection, and significant side effects, coinvestigator Kristina M. Deligiannidis, MD, director, Women’s Behavioral Health, Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.
“This newer approach, transcutaneous auricular VNS, is non-invasive, is well tolerated, and has shown initial efficacy in major depression in men and women,” she said.
The findings were presented at the virtual American Society of Clinical Psychopharmacology (ASCP) Annual Meeting.
Potential alternative to meds
“Given that aVNS is a non-invasive treatment which can be administered at home, we wanted to test if this approach was safe, feasible, and could reduce depressive symptoms in women with postpartum depression, as many of these women have barriers to accessing current treatments,” Dr. Deligiannidis said.
Auricular VNS uses surface skin electrodes to stimulate nerve endings of a branch of the vagus nerve, located on the surface of the outer ear. Those nerve endings travel to the brain where they have been shown to modulate brain communication in areas important for mood and anxiety regulation, she said.
Dr. Deligiannidis noted that evidence-based treatments for postpartum depression include psychotherapies and antidepressants. However, some women have difficulty accessing weekly psychotherapy, and, when antidepressants are indicated, many are reluctant to take them if they are breastfeeding because of concerns about the medications getting into their breast milk, she said.
Although most antidepressants are safe in lactation, many women postpone antidepressant treatment until they have finished breastfeeding, which can postpone their postpartum depression treatment, Dr. Deligiannidis added.
“At home treatments reduce many barriers women have to current treatments, and this intervention [of aVNS] does not impact breastfeeding, as it is not a medication approach,” she said.
The researchers enrolled 25 women (mean age, 33.7 years) diagnosed with postpartum depression. Ten of the women (40%) were on a stable dose of antidepressant medication.
The participants self-administered 6 weeks of open-label aVNS for 15 minutes daily at home. They were then observed without intervention for an additional 2 weeks. The women also completed medical, psychiatric, and safety interviews throughout the study period.
Promising findings
At baseline, the mean HAM-D17 was 18.4 and was similar for those on (17.8) and off (18.9) antidepressants.
By week 6, the mean HAM-D17 total score decreased by 9.7 points overall, compared with baseline score. For participants on antidepressants, the HAM-D17 decreased by 8.7 points; for women off antidepressants, it decreased by 10.3 points.
In addition, 74% of the women achieved a response to the therapy, and 61% achieved remission of their depressive symptoms.
The most common adverse effects were discomfort (n = 5 patients), headache (n = 3), and dizziness (n = 2). All resolved without intervention.
Commenting on the findings, Anita Clayton, MD, professor and chair, department of psychiatry and neurobehavioral sciences, University of Virginia School of Medicine, Charlottesville, said the study was “quite interesting.”
Dr. Clayton, who was not involved with the research, also noted the “pretty high” response and remission rates.
“So, I think this does have promise, and it would be worth doing a study where you look at placebo versus this treatment,” she said.
“Many women are fearful of taking medicines postpartum, even peripartum, unless they have had pre-existing severe depression. This is not a medicine, and it sounds like it could be useful even in people who are pregnant, although it’s harder to do studies in pregnant women,” Dr. Clayton added.
The study was funded by Nesos Corporation. Dr. Deligiannidis received contracted research funds from Nesos Corporation to conduct this study. She also serves as a consultant to Sage Therapeutics, Brii Biosciences, and GH Research. Dr. Clayton reports financial relationships with Dare Bioscience, Janssen, Praxis Precision Medicines, Relmada Therapeutics, Sage Therapeutics, AbbVie, Brii Biosciences, Fabre-Kramer, Field Trip Health, Mind Cure Health, Ovoca Bio, PureTech Health, S1 Biopharma, Takeda/Lundbeck, Vella Bioscience, WCG MedAvante-ProPhase, Ballantine Books/Random House, Changes in Sexual Functioning Questionnaire, Guilford Publications, Euthymics Bioscience, and Mediflix.
A version of this article first appeared on Medscape.com.
At-home, noninvasive auricular vagus nerve stimulation (aVNS) therapy is well-tolerated and associated with a significant reduction in postpartum depressive and anxiety symptoms, new research suggests.
In a small proof-of-concept pilot study of 25 women with postpartum depression receiving 6 weeks of daily aVNS treatment, results showed that 74% achieved response and 61% achieved remission, as shown in reduced scores on the Hamilton Rating Scale for Depression (HAM-D17).
Although invasive electrical stimulation of the vagus nerve was approved by the U.S. Food and Drug Administration for treatment-resistant depression in 2005, it involves risk for implantation, infection, and significant side effects, coinvestigator Kristina M. Deligiannidis, MD, director, Women’s Behavioral Health, Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.
“This newer approach, transcutaneous auricular VNS, is non-invasive, is well tolerated, and has shown initial efficacy in major depression in men and women,” she said.
The findings were presented at the virtual American Society of Clinical Psychopharmacology (ASCP) Annual Meeting.
Potential alternative to meds
“Given that aVNS is a non-invasive treatment which can be administered at home, we wanted to test if this approach was safe, feasible, and could reduce depressive symptoms in women with postpartum depression, as many of these women have barriers to accessing current treatments,” Dr. Deligiannidis said.
Auricular VNS uses surface skin electrodes to stimulate nerve endings of a branch of the vagus nerve, located on the surface of the outer ear. Those nerve endings travel to the brain where they have been shown to modulate brain communication in areas important for mood and anxiety regulation, she said.
Dr. Deligiannidis noted that evidence-based treatments for postpartum depression include psychotherapies and antidepressants. However, some women have difficulty accessing weekly psychotherapy, and, when antidepressants are indicated, many are reluctant to take them if they are breastfeeding because of concerns about the medications getting into their breast milk, she said.
Although most antidepressants are safe in lactation, many women postpone antidepressant treatment until they have finished breastfeeding, which can postpone their postpartum depression treatment, Dr. Deligiannidis added.
“At home treatments reduce many barriers women have to current treatments, and this intervention [of aVNS] does not impact breastfeeding, as it is not a medication approach,” she said.
The researchers enrolled 25 women (mean age, 33.7 years) diagnosed with postpartum depression. Ten of the women (40%) were on a stable dose of antidepressant medication.
The participants self-administered 6 weeks of open-label aVNS for 15 minutes daily at home. They were then observed without intervention for an additional 2 weeks. The women also completed medical, psychiatric, and safety interviews throughout the study period.
Promising findings
At baseline, the mean HAM-D17 was 18.4 and was similar for those on (17.8) and off (18.9) antidepressants.
By week 6, the mean HAM-D17 total score decreased by 9.7 points overall, compared with baseline score. For participants on antidepressants, the HAM-D17 decreased by 8.7 points; for women off antidepressants, it decreased by 10.3 points.
In addition, 74% of the women achieved a response to the therapy, and 61% achieved remission of their depressive symptoms.
The most common adverse effects were discomfort (n = 5 patients), headache (n = 3), and dizziness (n = 2). All resolved without intervention.
Commenting on the findings, Anita Clayton, MD, professor and chair, department of psychiatry and neurobehavioral sciences, University of Virginia School of Medicine, Charlottesville, said the study was “quite interesting.”
Dr. Clayton, who was not involved with the research, also noted the “pretty high” response and remission rates.
“So, I think this does have promise, and it would be worth doing a study where you look at placebo versus this treatment,” she said.
“Many women are fearful of taking medicines postpartum, even peripartum, unless they have had pre-existing severe depression. This is not a medicine, and it sounds like it could be useful even in people who are pregnant, although it’s harder to do studies in pregnant women,” Dr. Clayton added.
The study was funded by Nesos Corporation. Dr. Deligiannidis received contracted research funds from Nesos Corporation to conduct this study. She also serves as a consultant to Sage Therapeutics, Brii Biosciences, and GH Research. Dr. Clayton reports financial relationships with Dare Bioscience, Janssen, Praxis Precision Medicines, Relmada Therapeutics, Sage Therapeutics, AbbVie, Brii Biosciences, Fabre-Kramer, Field Trip Health, Mind Cure Health, Ovoca Bio, PureTech Health, S1 Biopharma, Takeda/Lundbeck, Vella Bioscience, WCG MedAvante-ProPhase, Ballantine Books/Random House, Changes in Sexual Functioning Questionnaire, Guilford Publications, Euthymics Bioscience, and Mediflix.
A version of this article first appeared on Medscape.com.
At-home, noninvasive auricular vagus nerve stimulation (aVNS) therapy is well-tolerated and associated with a significant reduction in postpartum depressive and anxiety symptoms, new research suggests.
In a small proof-of-concept pilot study of 25 women with postpartum depression receiving 6 weeks of daily aVNS treatment, results showed that 74% achieved response and 61% achieved remission, as shown in reduced scores on the Hamilton Rating Scale for Depression (HAM-D17).
Although invasive electrical stimulation of the vagus nerve was approved by the U.S. Food and Drug Administration for treatment-resistant depression in 2005, it involves risk for implantation, infection, and significant side effects, coinvestigator Kristina M. Deligiannidis, MD, director, Women’s Behavioral Health, Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.
“This newer approach, transcutaneous auricular VNS, is non-invasive, is well tolerated, and has shown initial efficacy in major depression in men and women,” she said.
The findings were presented at the virtual American Society of Clinical Psychopharmacology (ASCP) Annual Meeting.
Potential alternative to meds
“Given that aVNS is a non-invasive treatment which can be administered at home, we wanted to test if this approach was safe, feasible, and could reduce depressive symptoms in women with postpartum depression, as many of these women have barriers to accessing current treatments,” Dr. Deligiannidis said.
Auricular VNS uses surface skin electrodes to stimulate nerve endings of a branch of the vagus nerve, located on the surface of the outer ear. Those nerve endings travel to the brain where they have been shown to modulate brain communication in areas important for mood and anxiety regulation, she said.
Dr. Deligiannidis noted that evidence-based treatments for postpartum depression include psychotherapies and antidepressants. However, some women have difficulty accessing weekly psychotherapy, and, when antidepressants are indicated, many are reluctant to take them if they are breastfeeding because of concerns about the medications getting into their breast milk, she said.
Although most antidepressants are safe in lactation, many women postpone antidepressant treatment until they have finished breastfeeding, which can postpone their postpartum depression treatment, Dr. Deligiannidis added.
“At home treatments reduce many barriers women have to current treatments, and this intervention [of aVNS] does not impact breastfeeding, as it is not a medication approach,” she said.
The researchers enrolled 25 women (mean age, 33.7 years) diagnosed with postpartum depression. Ten of the women (40%) were on a stable dose of antidepressant medication.
The participants self-administered 6 weeks of open-label aVNS for 15 minutes daily at home. They were then observed without intervention for an additional 2 weeks. The women also completed medical, psychiatric, and safety interviews throughout the study period.
Promising findings
At baseline, the mean HAM-D17 was 18.4 and was similar for those on (17.8) and off (18.9) antidepressants.
By week 6, the mean HAM-D17 total score decreased by 9.7 points overall, compared with baseline score. For participants on antidepressants, the HAM-D17 decreased by 8.7 points; for women off antidepressants, it decreased by 10.3 points.
In addition, 74% of the women achieved a response to the therapy, and 61% achieved remission of their depressive symptoms.
The most common adverse effects were discomfort (n = 5 patients), headache (n = 3), and dizziness (n = 2). All resolved without intervention.
Commenting on the findings, Anita Clayton, MD, professor and chair, department of psychiatry and neurobehavioral sciences, University of Virginia School of Medicine, Charlottesville, said the study was “quite interesting.”
Dr. Clayton, who was not involved with the research, also noted the “pretty high” response and remission rates.
“So, I think this does have promise, and it would be worth doing a study where you look at placebo versus this treatment,” she said.
“Many women are fearful of taking medicines postpartum, even peripartum, unless they have had pre-existing severe depression. This is not a medicine, and it sounds like it could be useful even in people who are pregnant, although it’s harder to do studies in pregnant women,” Dr. Clayton added.
The study was funded by Nesos Corporation. Dr. Deligiannidis received contracted research funds from Nesos Corporation to conduct this study. She also serves as a consultant to Sage Therapeutics, Brii Biosciences, and GH Research. Dr. Clayton reports financial relationships with Dare Bioscience, Janssen, Praxis Precision Medicines, Relmada Therapeutics, Sage Therapeutics, AbbVie, Brii Biosciences, Fabre-Kramer, Field Trip Health, Mind Cure Health, Ovoca Bio, PureTech Health, S1 Biopharma, Takeda/Lundbeck, Vella Bioscience, WCG MedAvante-ProPhase, Ballantine Books/Random House, Changes in Sexual Functioning Questionnaire, Guilford Publications, Euthymics Bioscience, and Mediflix.
A version of this article first appeared on Medscape.com.