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Once-weekly oral antipsychotic for schizophrenia on the horizon
A novel, ultra–long-acting oral formulation of the antipsychotic risperidone (Risperdal) only needs to be taken once weekly and appears to be safe and effective, results of a new phase 2 study suggest.
The new formulation, LYN-005 (Lyndra Therapeutics), quickly reached therapeutic levels in patients, provided sustained exposure to risperidone active moiety over 7 days, and reduced peak drug exposure.
“This novel formulation has the potential to improve treatment adherence and quality of life in patients with schizophrenia or schizoaffective disorder,” study investigator David Walling, PhD, chief clinical officer for the Collaborative NeuroScience Network, Long Beach, Calif., said in an interview.
The findings were presented at the 2021 American Society of Clinical Psychopharmacology annual meeting.
Adherence is key
About 50% of patients don’t take medications as prescribed, creating a significant relapse risk, Dr. Walling noted.
“Here we have the possibility of having a once-weekly oral medication, which means patients don’t have to struggle with the issue of taking the medication daily. Right now, all we have on the market for long-acting medications for schizophrenia are injectables, where the patient has to go get a shot every month or every 2 weeks in order to have the medication in their system for a longer period of time,” he added.
The study included 32 clinically stable patients with a primary diagnosis of schizophrenia or schizoaffective disorder.
Patients received immediate-release (IR) risperidone at 2 mg or 4 mg, based on their current antipsychotic dose, for 13 days.
They were then randomly assigned 3:1 to receive either IR risperidone-matched placebo and LYN-005 at 14 mg or 28 mg risperidone (12 patients per group), or to LYN-005 matched placebo and IR risperidone, 2 mg or 4 mg, (4 patients per group) for 3 weeks.
LYN-05 was administered once weekly for a total of three doses. IR risperidone was administered once daily.
The study’s primary endpoints were pharmacokinetics after LYN-005 and IR risperidone and the incidence of adverse events.
Following LYN-005 administration, systemic exposure to risperidone active moiety (risperidone and 9-hydroxyrisperidone combined) increased with the increasing dose. Peak concentration occurred within the first 3 days of dosing and peak exposures from LYN-005 were lower than with IR risperidone.
“Steady state was achieved around day 15. It didn’t take 3 weeks of dosing for patients to achieve steady state. We achieved that around day 15,” Dr. Walling said.
LYN-005 was well tolerated in the 85% of study participants who received all three doses.
Adverse events occurred in 18 (75%) patients who received LYN-005. Of these, 10 were with the 14-mg dose, and 8 with the 28-mg dose.
The most common AEs were gastrointestinal, which occurred in 13 (54%) patients receiving LYN-005, with a higher incidence in the 28-mg group than in the 14 mg group.
Additionally, nine patients had abdominal pain, discomfort, or tenderness, and five patients (21%) had nausea.
Overall, the incidence of adverse events was higher for LYN-005, compared with IR risperidone, but they were judged to be mild and transitory, with fewer AEs reported with subsequent LYN-005 dosing. After the first dose, 58% of patients reported an AE; this dropped to 18% after the third dose.
An important development
Commenting on the findings, Ira D. Glick, MD, professor emeritus, Stanford (Calif.) University, said: “The major problem with schizophrenia is getting adherence.”
“The better the adherence, the better the outcome, the worst the adherence, the worse the outcome, so being able to take a preparation less often is a very important advance in the field,” said Dr. Glick, who was not involved in the research
Long-acting preparations for chronic mental illness represent a significant advance, he said.
“The future of the treatment of schizophrenia is long-acting injectables. That is the trend,” Dr. Glick explained. “The oral once-a-week preparation may be useful in a group of patients who are phobic about needles, but with the injections, you can be sure that the patient has received their medication. With the oral, there is more of a chance to be noncompliant.
“That said, having an effective, longer-acting oral for those who refuse injections is helpful. to ensure adherence to treatment. We know treatment works, we know it is going to save lives, and that’s what this ultra–long-acting formulation is promoting.”
Dr. Glick has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A novel, ultra–long-acting oral formulation of the antipsychotic risperidone (Risperdal) only needs to be taken once weekly and appears to be safe and effective, results of a new phase 2 study suggest.
The new formulation, LYN-005 (Lyndra Therapeutics), quickly reached therapeutic levels in patients, provided sustained exposure to risperidone active moiety over 7 days, and reduced peak drug exposure.
“This novel formulation has the potential to improve treatment adherence and quality of life in patients with schizophrenia or schizoaffective disorder,” study investigator David Walling, PhD, chief clinical officer for the Collaborative NeuroScience Network, Long Beach, Calif., said in an interview.
The findings were presented at the 2021 American Society of Clinical Psychopharmacology annual meeting.
Adherence is key
About 50% of patients don’t take medications as prescribed, creating a significant relapse risk, Dr. Walling noted.
“Here we have the possibility of having a once-weekly oral medication, which means patients don’t have to struggle with the issue of taking the medication daily. Right now, all we have on the market for long-acting medications for schizophrenia are injectables, where the patient has to go get a shot every month or every 2 weeks in order to have the medication in their system for a longer period of time,” he added.
The study included 32 clinically stable patients with a primary diagnosis of schizophrenia or schizoaffective disorder.
Patients received immediate-release (IR) risperidone at 2 mg or 4 mg, based on their current antipsychotic dose, for 13 days.
They were then randomly assigned 3:1 to receive either IR risperidone-matched placebo and LYN-005 at 14 mg or 28 mg risperidone (12 patients per group), or to LYN-005 matched placebo and IR risperidone, 2 mg or 4 mg, (4 patients per group) for 3 weeks.
LYN-05 was administered once weekly for a total of three doses. IR risperidone was administered once daily.
The study’s primary endpoints were pharmacokinetics after LYN-005 and IR risperidone and the incidence of adverse events.
Following LYN-005 administration, systemic exposure to risperidone active moiety (risperidone and 9-hydroxyrisperidone combined) increased with the increasing dose. Peak concentration occurred within the first 3 days of dosing and peak exposures from LYN-005 were lower than with IR risperidone.
“Steady state was achieved around day 15. It didn’t take 3 weeks of dosing for patients to achieve steady state. We achieved that around day 15,” Dr. Walling said.
LYN-005 was well tolerated in the 85% of study participants who received all three doses.
Adverse events occurred in 18 (75%) patients who received LYN-005. Of these, 10 were with the 14-mg dose, and 8 with the 28-mg dose.
The most common AEs were gastrointestinal, which occurred in 13 (54%) patients receiving LYN-005, with a higher incidence in the 28-mg group than in the 14 mg group.
Additionally, nine patients had abdominal pain, discomfort, or tenderness, and five patients (21%) had nausea.
Overall, the incidence of adverse events was higher for LYN-005, compared with IR risperidone, but they were judged to be mild and transitory, with fewer AEs reported with subsequent LYN-005 dosing. After the first dose, 58% of patients reported an AE; this dropped to 18% after the third dose.
An important development
Commenting on the findings, Ira D. Glick, MD, professor emeritus, Stanford (Calif.) University, said: “The major problem with schizophrenia is getting adherence.”
“The better the adherence, the better the outcome, the worst the adherence, the worse the outcome, so being able to take a preparation less often is a very important advance in the field,” said Dr. Glick, who was not involved in the research
Long-acting preparations for chronic mental illness represent a significant advance, he said.
“The future of the treatment of schizophrenia is long-acting injectables. That is the trend,” Dr. Glick explained. “The oral once-a-week preparation may be useful in a group of patients who are phobic about needles, but with the injections, you can be sure that the patient has received their medication. With the oral, there is more of a chance to be noncompliant.
“That said, having an effective, longer-acting oral for those who refuse injections is helpful. to ensure adherence to treatment. We know treatment works, we know it is going to save lives, and that’s what this ultra–long-acting formulation is promoting.”
Dr. Glick has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A novel, ultra–long-acting oral formulation of the antipsychotic risperidone (Risperdal) only needs to be taken once weekly and appears to be safe and effective, results of a new phase 2 study suggest.
The new formulation, LYN-005 (Lyndra Therapeutics), quickly reached therapeutic levels in patients, provided sustained exposure to risperidone active moiety over 7 days, and reduced peak drug exposure.
“This novel formulation has the potential to improve treatment adherence and quality of life in patients with schizophrenia or schizoaffective disorder,” study investigator David Walling, PhD, chief clinical officer for the Collaborative NeuroScience Network, Long Beach, Calif., said in an interview.
The findings were presented at the 2021 American Society of Clinical Psychopharmacology annual meeting.
Adherence is key
About 50% of patients don’t take medications as prescribed, creating a significant relapse risk, Dr. Walling noted.
“Here we have the possibility of having a once-weekly oral medication, which means patients don’t have to struggle with the issue of taking the medication daily. Right now, all we have on the market for long-acting medications for schizophrenia are injectables, where the patient has to go get a shot every month or every 2 weeks in order to have the medication in their system for a longer period of time,” he added.
The study included 32 clinically stable patients with a primary diagnosis of schizophrenia or schizoaffective disorder.
Patients received immediate-release (IR) risperidone at 2 mg or 4 mg, based on their current antipsychotic dose, for 13 days.
They were then randomly assigned 3:1 to receive either IR risperidone-matched placebo and LYN-005 at 14 mg or 28 mg risperidone (12 patients per group), or to LYN-005 matched placebo and IR risperidone, 2 mg or 4 mg, (4 patients per group) for 3 weeks.
LYN-05 was administered once weekly for a total of three doses. IR risperidone was administered once daily.
The study’s primary endpoints were pharmacokinetics after LYN-005 and IR risperidone and the incidence of adverse events.
Following LYN-005 administration, systemic exposure to risperidone active moiety (risperidone and 9-hydroxyrisperidone combined) increased with the increasing dose. Peak concentration occurred within the first 3 days of dosing and peak exposures from LYN-005 were lower than with IR risperidone.
“Steady state was achieved around day 15. It didn’t take 3 weeks of dosing for patients to achieve steady state. We achieved that around day 15,” Dr. Walling said.
LYN-005 was well tolerated in the 85% of study participants who received all three doses.
Adverse events occurred in 18 (75%) patients who received LYN-005. Of these, 10 were with the 14-mg dose, and 8 with the 28-mg dose.
The most common AEs were gastrointestinal, which occurred in 13 (54%) patients receiving LYN-005, with a higher incidence in the 28-mg group than in the 14 mg group.
Additionally, nine patients had abdominal pain, discomfort, or tenderness, and five patients (21%) had nausea.
Overall, the incidence of adverse events was higher for LYN-005, compared with IR risperidone, but they were judged to be mild and transitory, with fewer AEs reported with subsequent LYN-005 dosing. After the first dose, 58% of patients reported an AE; this dropped to 18% after the third dose.
An important development
Commenting on the findings, Ira D. Glick, MD, professor emeritus, Stanford (Calif.) University, said: “The major problem with schizophrenia is getting adherence.”
“The better the adherence, the better the outcome, the worst the adherence, the worse the outcome, so being able to take a preparation less often is a very important advance in the field,” said Dr. Glick, who was not involved in the research
Long-acting preparations for chronic mental illness represent a significant advance, he said.
“The future of the treatment of schizophrenia is long-acting injectables. That is the trend,” Dr. Glick explained. “The oral once-a-week preparation may be useful in a group of patients who are phobic about needles, but with the injections, you can be sure that the patient has received their medication. With the oral, there is more of a chance to be noncompliant.
“That said, having an effective, longer-acting oral for those who refuse injections is helpful. to ensure adherence to treatment. We know treatment works, we know it is going to save lives, and that’s what this ultra–long-acting formulation is promoting.”
Dr. Glick has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Novel text-messaging program boosts ADHD treatment adherence
An innovative text-messaging program that reminds patients with attention-deficit/hyperactivity disorder to take their medication and warns them about the hazards of noncompliance significantly increases treatment adherence in children and adults, new research suggests.
In a pediatric study, 85% of participants who received a text message had their prescriptions refilled in a timely manner, compared with 62% of those who received treatment as usual and no text messaging. In a second study of adults, 81% of the group that received a text message refilled their prescriptions, versus 36% of those in the usual-treatment group.
“Patients are not going to be fully compliant if they do not understand what the implications are if they do not take their pills,” lead author Joseph Biederman, MD, chief of clinical and research programs in pediatric psychopharmacology and adult ADHD at the Massachusetts General Hospital and professor of psychiatry at Harvard Medical School, Boston, told this news organization.
He noted that the text-messaging program also provides information, support, encouragement, and guidance.
“We remind them to get in touch with their prescriber as renewals come due, and if they tell us no, we tell them how important it is” to do so, Dr. Biederman said.
The findings were presented at the virtual American Society of Clinical Psychopharmacology 2021 annual meeting.
Poor adherence
“Adherence to medications for ADHD is extremely poor, among the worst in medicine, despite the fact that ADHD is very morbid and we have excellent treatments people can take,” Dr. Biederman noted. “That’s the first tragedy, and it is totally unappreciated.”
He added that when patients require multiple prescriptions, he said.
Another contributor to medication nonadherence is the ongoing prejudice or stigma associated with ADHD, said Dr. Biederman.
“There is bad press about ADHD. There are no good comments, only disaster, doom and gloom, catastrophe, and so on. All people read in the available media are bad things about ADHD, and that only adds to stigma and misinformation,” he noted.
To combat these factors, Dr. Biederman and his team conducted two studies on the effectiveness of a novel ADHD-centric intervention based on text messaging.
One study included 87 children aged 6-12 years, and the other included 117 adults aged 18-55 years. Both groups were from primary care settings and were prescribed a stimulant medication for the treatment of ADHD.
As comparators, the researchers used age- and sex-matched pediatric patients and age-, race-, and sex-matched adult patients from the same primary care settings. They had also been prescribed stimulants but had not received the text messaging intervention.
Timely reminders
Results showed that 85% of the children who received text messages refilled their prescriptions vs. 65% of those who did not get the intervention (odds ratio, 3.46; 95% confidence interval, 1.82-6.58; P < .001).
Among adults, 81% of the intervention group refilled their prescriptions vs. 36% of the comparator group (OR, 7.54; 95% CI, 4.46-12.77; P < .001).
“In the number-needed-to-treat analysis, for every five pediatric patients who receive text messaging, we can keep one adherent with stimulant medication. In adults, that is one in every three who receive the text-messaging intervention,” Dr. Biederman said.
Text messaging reminds patients with ADHD to take their medications as prescribed, and it also reminds them of the consequences of not taking their medications, he added.
In another study presented at the ASCP meeting, Dr. Biederman introduced a new tool to help clinicians determine whether a patient with ADHD also has deficient emotional self-regulation (DESR).
ADHD has been associated with low frustration tolerance, impatience, and quickness to anger, he noted.
Emotional dysregulation, however, “is not a mood disorder,” said Dr. Biederman. “Some people use the term ‘hot tempered.’ These are people who overreact to things, and this is associated with a wide range of difficulties.”
Clinical guidance
The investigators operationalized DESR using the eight-item Emotional Dysregulation (ED) subscale of the Barkley Current Behavior Scale. They then used receiver operating characteristic curves to identify the optimal cutoff on the Barkley ED Scale that would categorize patients as having high- vs. low-level DESR.
“We wanted to give some guidance to clinicians, using a very simple rating scale that was developed by Dr. Barkley. It is one we think configures this syndrome of emotional dysregulation and emotional impulsivity,” Dr. Biederman said.
The study included 441 newly referred 18- to 55-year-old men and women who met DSM-5 diagnostic criteria for ADHD.
Using a cutoff score of 8 to represent high levels of DESR, the researchers identified 191 adults as having high-level DESR and the rest as having low-level DESR.
Those with high-level DESR had significantly more severe symptoms of ADHD, executive dysfunction, autistic traits, levels of psychopathology, and worse quality of life, compared with those with low-level DESR.
The problem of emotional dysregulation in ADHD is widespread and affects many people, Dr. Biederman noted.
“If you take 5% of adults at a minimum and 10% of children with ADHD [and] if 50% of those have emotional dysregulation, we’re talking about millions of people. And it is very morbid,” he said. “Having emotional dysregulation problems will get you in hot water.”
Promising results
Commenting on the findings for this news organization, Ira D. Glick, MD, professor emeritus of psychiatry and behavioral sciences, Stanford (Calif.) University, said the new studies are important.
He noted that, although ADHD has become more accepted as a “disease of the brain” over the past 20 years, patients with the disorder and their families often are not accepting of the diagnosis.
“Instead, they try to downplay it. They say this is just a ploy by psychiatrists to get business or this is just normal boys’ behavior, [and] they don’t need medicines,” said Dr. Glick, who was not involved in the current research.
“Biederman is trying to make clear that ADHD is a brain disease, and DESR symptoms are cardinal signs of a brain illness,” he said.
Dr. Glick also agreed that text messaging could be very useful for these patients.
“Text messaging might be helpful, especially in this population which can often be disorganized or forgetful. The results of that study were very promising,” he said.
Dr. Biederman is in the process of commercializing the text program used in the study. Dr. Glick reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An innovative text-messaging program that reminds patients with attention-deficit/hyperactivity disorder to take their medication and warns them about the hazards of noncompliance significantly increases treatment adherence in children and adults, new research suggests.
In a pediatric study, 85% of participants who received a text message had their prescriptions refilled in a timely manner, compared with 62% of those who received treatment as usual and no text messaging. In a second study of adults, 81% of the group that received a text message refilled their prescriptions, versus 36% of those in the usual-treatment group.
“Patients are not going to be fully compliant if they do not understand what the implications are if they do not take their pills,” lead author Joseph Biederman, MD, chief of clinical and research programs in pediatric psychopharmacology and adult ADHD at the Massachusetts General Hospital and professor of psychiatry at Harvard Medical School, Boston, told this news organization.
He noted that the text-messaging program also provides information, support, encouragement, and guidance.
“We remind them to get in touch with their prescriber as renewals come due, and if they tell us no, we tell them how important it is” to do so, Dr. Biederman said.
The findings were presented at the virtual American Society of Clinical Psychopharmacology 2021 annual meeting.
Poor adherence
“Adherence to medications for ADHD is extremely poor, among the worst in medicine, despite the fact that ADHD is very morbid and we have excellent treatments people can take,” Dr. Biederman noted. “That’s the first tragedy, and it is totally unappreciated.”
He added that when patients require multiple prescriptions, he said.
Another contributor to medication nonadherence is the ongoing prejudice or stigma associated with ADHD, said Dr. Biederman.
“There is bad press about ADHD. There are no good comments, only disaster, doom and gloom, catastrophe, and so on. All people read in the available media are bad things about ADHD, and that only adds to stigma and misinformation,” he noted.
To combat these factors, Dr. Biederman and his team conducted two studies on the effectiveness of a novel ADHD-centric intervention based on text messaging.
One study included 87 children aged 6-12 years, and the other included 117 adults aged 18-55 years. Both groups were from primary care settings and were prescribed a stimulant medication for the treatment of ADHD.
As comparators, the researchers used age- and sex-matched pediatric patients and age-, race-, and sex-matched adult patients from the same primary care settings. They had also been prescribed stimulants but had not received the text messaging intervention.
Timely reminders
Results showed that 85% of the children who received text messages refilled their prescriptions vs. 65% of those who did not get the intervention (odds ratio, 3.46; 95% confidence interval, 1.82-6.58; P < .001).
Among adults, 81% of the intervention group refilled their prescriptions vs. 36% of the comparator group (OR, 7.54; 95% CI, 4.46-12.77; P < .001).
“In the number-needed-to-treat analysis, for every five pediatric patients who receive text messaging, we can keep one adherent with stimulant medication. In adults, that is one in every three who receive the text-messaging intervention,” Dr. Biederman said.
Text messaging reminds patients with ADHD to take their medications as prescribed, and it also reminds them of the consequences of not taking their medications, he added.
In another study presented at the ASCP meeting, Dr. Biederman introduced a new tool to help clinicians determine whether a patient with ADHD also has deficient emotional self-regulation (DESR).
ADHD has been associated with low frustration tolerance, impatience, and quickness to anger, he noted.
Emotional dysregulation, however, “is not a mood disorder,” said Dr. Biederman. “Some people use the term ‘hot tempered.’ These are people who overreact to things, and this is associated with a wide range of difficulties.”
Clinical guidance
The investigators operationalized DESR using the eight-item Emotional Dysregulation (ED) subscale of the Barkley Current Behavior Scale. They then used receiver operating characteristic curves to identify the optimal cutoff on the Barkley ED Scale that would categorize patients as having high- vs. low-level DESR.
“We wanted to give some guidance to clinicians, using a very simple rating scale that was developed by Dr. Barkley. It is one we think configures this syndrome of emotional dysregulation and emotional impulsivity,” Dr. Biederman said.
The study included 441 newly referred 18- to 55-year-old men and women who met DSM-5 diagnostic criteria for ADHD.
Using a cutoff score of 8 to represent high levels of DESR, the researchers identified 191 adults as having high-level DESR and the rest as having low-level DESR.
Those with high-level DESR had significantly more severe symptoms of ADHD, executive dysfunction, autistic traits, levels of psychopathology, and worse quality of life, compared with those with low-level DESR.
The problem of emotional dysregulation in ADHD is widespread and affects many people, Dr. Biederman noted.
“If you take 5% of adults at a minimum and 10% of children with ADHD [and] if 50% of those have emotional dysregulation, we’re talking about millions of people. And it is very morbid,” he said. “Having emotional dysregulation problems will get you in hot water.”
Promising results
Commenting on the findings for this news organization, Ira D. Glick, MD, professor emeritus of psychiatry and behavioral sciences, Stanford (Calif.) University, said the new studies are important.
He noted that, although ADHD has become more accepted as a “disease of the brain” over the past 20 years, patients with the disorder and their families often are not accepting of the diagnosis.
“Instead, they try to downplay it. They say this is just a ploy by psychiatrists to get business or this is just normal boys’ behavior, [and] they don’t need medicines,” said Dr. Glick, who was not involved in the current research.
“Biederman is trying to make clear that ADHD is a brain disease, and DESR symptoms are cardinal signs of a brain illness,” he said.
Dr. Glick also agreed that text messaging could be very useful for these patients.
“Text messaging might be helpful, especially in this population which can often be disorganized or forgetful. The results of that study were very promising,” he said.
Dr. Biederman is in the process of commercializing the text program used in the study. Dr. Glick reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.
An innovative text-messaging program that reminds patients with attention-deficit/hyperactivity disorder to take their medication and warns them about the hazards of noncompliance significantly increases treatment adherence in children and adults, new research suggests.
In a pediatric study, 85% of participants who received a text message had their prescriptions refilled in a timely manner, compared with 62% of those who received treatment as usual and no text messaging. In a second study of adults, 81% of the group that received a text message refilled their prescriptions, versus 36% of those in the usual-treatment group.
“Patients are not going to be fully compliant if they do not understand what the implications are if they do not take their pills,” lead author Joseph Biederman, MD, chief of clinical and research programs in pediatric psychopharmacology and adult ADHD at the Massachusetts General Hospital and professor of psychiatry at Harvard Medical School, Boston, told this news organization.
He noted that the text-messaging program also provides information, support, encouragement, and guidance.
“We remind them to get in touch with their prescriber as renewals come due, and if they tell us no, we tell them how important it is” to do so, Dr. Biederman said.
The findings were presented at the virtual American Society of Clinical Psychopharmacology 2021 annual meeting.
Poor adherence
“Adherence to medications for ADHD is extremely poor, among the worst in medicine, despite the fact that ADHD is very morbid and we have excellent treatments people can take,” Dr. Biederman noted. “That’s the first tragedy, and it is totally unappreciated.”
He added that when patients require multiple prescriptions, he said.
Another contributor to medication nonadherence is the ongoing prejudice or stigma associated with ADHD, said Dr. Biederman.
“There is bad press about ADHD. There are no good comments, only disaster, doom and gloom, catastrophe, and so on. All people read in the available media are bad things about ADHD, and that only adds to stigma and misinformation,” he noted.
To combat these factors, Dr. Biederman and his team conducted two studies on the effectiveness of a novel ADHD-centric intervention based on text messaging.
One study included 87 children aged 6-12 years, and the other included 117 adults aged 18-55 years. Both groups were from primary care settings and were prescribed a stimulant medication for the treatment of ADHD.
As comparators, the researchers used age- and sex-matched pediatric patients and age-, race-, and sex-matched adult patients from the same primary care settings. They had also been prescribed stimulants but had not received the text messaging intervention.
Timely reminders
Results showed that 85% of the children who received text messages refilled their prescriptions vs. 65% of those who did not get the intervention (odds ratio, 3.46; 95% confidence interval, 1.82-6.58; P < .001).
Among adults, 81% of the intervention group refilled their prescriptions vs. 36% of the comparator group (OR, 7.54; 95% CI, 4.46-12.77; P < .001).
“In the number-needed-to-treat analysis, for every five pediatric patients who receive text messaging, we can keep one adherent with stimulant medication. In adults, that is one in every three who receive the text-messaging intervention,” Dr. Biederman said.
Text messaging reminds patients with ADHD to take their medications as prescribed, and it also reminds them of the consequences of not taking their medications, he added.
In another study presented at the ASCP meeting, Dr. Biederman introduced a new tool to help clinicians determine whether a patient with ADHD also has deficient emotional self-regulation (DESR).
ADHD has been associated with low frustration tolerance, impatience, and quickness to anger, he noted.
Emotional dysregulation, however, “is not a mood disorder,” said Dr. Biederman. “Some people use the term ‘hot tempered.’ These are people who overreact to things, and this is associated with a wide range of difficulties.”
Clinical guidance
The investigators operationalized DESR using the eight-item Emotional Dysregulation (ED) subscale of the Barkley Current Behavior Scale. They then used receiver operating characteristic curves to identify the optimal cutoff on the Barkley ED Scale that would categorize patients as having high- vs. low-level DESR.
“We wanted to give some guidance to clinicians, using a very simple rating scale that was developed by Dr. Barkley. It is one we think configures this syndrome of emotional dysregulation and emotional impulsivity,” Dr. Biederman said.
The study included 441 newly referred 18- to 55-year-old men and women who met DSM-5 diagnostic criteria for ADHD.
Using a cutoff score of 8 to represent high levels of DESR, the researchers identified 191 adults as having high-level DESR and the rest as having low-level DESR.
Those with high-level DESR had significantly more severe symptoms of ADHD, executive dysfunction, autistic traits, levels of psychopathology, and worse quality of life, compared with those with low-level DESR.
The problem of emotional dysregulation in ADHD is widespread and affects many people, Dr. Biederman noted.
“If you take 5% of adults at a minimum and 10% of children with ADHD [and] if 50% of those have emotional dysregulation, we’re talking about millions of people. And it is very morbid,” he said. “Having emotional dysregulation problems will get you in hot water.”
Promising results
Commenting on the findings for this news organization, Ira D. Glick, MD, professor emeritus of psychiatry and behavioral sciences, Stanford (Calif.) University, said the new studies are important.
He noted that, although ADHD has become more accepted as a “disease of the brain” over the past 20 years, patients with the disorder and their families often are not accepting of the diagnosis.
“Instead, they try to downplay it. They say this is just a ploy by psychiatrists to get business or this is just normal boys’ behavior, [and] they don’t need medicines,” said Dr. Glick, who was not involved in the current research.
“Biederman is trying to make clear that ADHD is a brain disease, and DESR symptoms are cardinal signs of a brain illness,” he said.
Dr. Glick also agreed that text messaging could be very useful for these patients.
“Text messaging might be helpful, especially in this population which can often be disorganized or forgetful. The results of that study were very promising,” he said.
Dr. Biederman is in the process of commercializing the text program used in the study. Dr. Glick reports no relevant financial relationships.
A version of this article first appeared on Medscape.com.