Youth Seeing PCPs for Mental Health Problems More Likely to Get Medication

More than one-third of U.S. children and adolescents receiving outpatient care for mental health conditions from 2008 to 2011 saw only a primary care physician (PCP) for their care—a proportion that exceeded those treated by only a psychiatrist—according to a study in Pediatrics.

To determine how the proportion of youth seen and/or prescribed medications for mental health conditions by PCPs compared with other mental health providers, researchers from MassGeneral Hospital for Children and Brigham and Women's Hospital in Boston examined data from the Medical Expenditure Panel Survey (MEPS). The analysis incorporated data collected from 2008 to 2011, which included 43,235 U.S. children and adolescents aged 2 to 21 years.

The researchers found that 1,778 children and adolescents aged 2 to 21 were reported to have had an office-based or outpatient visit for a mental health condition, with a mean of 5.4 visits per child with any mental health visits. Of those who had a visit for any mental health condition, 34.8% saw only a PCP, 26.2% saw only a psychiatrist, 15.2% saw only a psychologist or social worker, and 23.8% saw multiple providers. A greater proportion of youth with attention-deficit/hyperactivity disorder (ADHD) versus youth with anxiety/mood disorders saw a PCP only (41.8% vs 17.2%).

The study also revealed that youth who had a visit with a PCP were more likely to be prescribed a psychotropic medication than those who saw a psychiatrist: 70.2% versus 63.0% of children for any mental health condition, 73.7% versus 61.4% for ADHD, and 59.7% versus 45.9% for anxiety/mood disorders. Youth with ADHD seen by PCPs had 1.5 times the odds of receiving a medication than did those seen by psychiatrists.

“This study suggests PCPs alone care for a greater proportion of children receiving mental health care than do psychiatrists or psychologists/social workers, especially in the treatment of ADHD. However, fewer than half of children had any involvement from their PCP, and comanagement with other mental health specialists, especially psychiatrists, appears uncommon,” the study authors noted. “[I]n an effort to assist PCPs in their involvement in pediatric mental health care, further emphasis should be placed on collaborative care models with psychotherapy and programs that provide point-of-care advice to PCPs from mental health experts.”

For related information, see the Psychiatric News article “Pediatricians Urged to Adhere Better to ADHD Care Practices.”

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Asenapine Found to Be Safe, Effective in Youth With Manic or Mixed Episode of Bipolar I Disorder

The second-generation antipsychotic asenapine may help to reduce mania and the severity of illness in youth with bipolar I disorder within days, according to a study published in the December issue of the Journal of the American Academy of Child and Adolescent Psychiatry.

Robert Findling, M.D. (pictured left), the director of the Division of Child and Adolescent Psychiatry at Johns Hopkins University School of Medicine, and colleagues randomly assigned 403 youth (aged 10 to 17) displaying manic or mixed episodes of bipolar I disorder to receive placebo or asenapine (2.5 mg, 5 mg, or 10 mg) twice daily for three weeks.

The researchers found that all three doses of asenapine led to statistically significant improvements in Young-Mania Rating Scale (YMRS) scores and Clinical Global Impression scale for use in Bipolar Illness (CGI-BP) from days 4 and 7 onward. By day 21, a positive drug response (greater than 50% reduction in YMRS scores from baseline) was achieved by 42% to 54% of those taking asenapine compared with 28% among youth taking placebo. There were no significant differences in YMRS total score between the asenapine groups versus the placebo group in patients with and without attention-deficit/hyperactivity disorder, with and without concomitant stimulant use, or with respect to age and gender.

The incidence of clinically significant weight gain at 21 days was statistically significant versus that of placebo in all three asenapine groups (asenapine range 8.0%–12.0% versus placebo 1.1%). Mean changes from baseline in lipid parameters, glucose, and fasting insulin were also greater in patients treated with asenapine compared with those who took placebo. Other treatment-emergent adverse events reported by patients taking asenapine included somnolence, sedation, increased appetite, and numbness and tingling of the mouth.

“These results suggest the potential for substantial long-term metabolic changes in pediatric patients treated with asenapine. Because of the known metabolic side effects that occur in children and adolescents prescribed atypical antipsychotics, baseline and period monitoring of metabolic parameters including BMI, lipids, and glucose levels is recommended,” Findling and colleagues wrote.

To read more about pharmacological treatment of pediatric bipolar disorder, see the Psychiatric News article “Experts Make Strong Case for Lithium in Youth With Bipolar Disorder.”

(Photo Courtesy of Johns Hopkins University SOM)

Participation in Mental Health Courts May Lessen Future Arrests

Criminal defendants who enter mental health court programs may perceive their treatment as significantly less voluntary than those not participating in such programs, but they appear to experience better outcomes, according to a study published in Psychiatric Services in Advance.

Woojae Han, M.S.W., of the University of Albany, and Allison Redlich, Ph.D., of George Mason University compared the treatment outcomes of 357 defendants in mental health courts with 384 people with mental health problems who had recently entered the legal system, examining the impact of community mental health and substance abuse treatment on recidivism at the time of court entry and six months later.

Analysis of interview data with the participants and national arrest data revealed significant increases in treatment motivation and use of community mental health and substance abuse services among participants in the mental health courts compared with the others; however, the perceived voluntariness of treatment decreased in the mental health court group. Increased medication compliance and mental health service use were associated with a significant decrease in arrests for the mental health court group, but not the control group, the authors reported.

“This finding suggests that treatment itself may not lead to meaningful criminal justice outcomes (for example, reduced arrests) but that treatment combined with court monitoring decreases arrests for offenders with mental illness,” the study authors wrote.

For more in Psychiatric News about mental health courts, see “Mental Health Courts: An Effective Alternative to Incarceration” and “MH Court Cuts Violence, Even in Felony Cases.”

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Meta-Analysis Finds Stimulants Reduce Quality, Quantity of Sleep in Youth With ADHD

Stimulant medications appear to reduce the quantity and quality of sleep for children with attention-deficit/hyperactivity disorder (ADHD), according to a meta-analysis published online today in Pediatrics. The findings suggest that clinicians should carefully monitor sleeping behaviors of children taking these medications and adjust treatment to promote optimal sleep.

Previous studies examining the effects of stimulants on sleep in youth with ADHD have produced contradictory findings, with some suggesting that stimulants impair sleep while others propose the medication leads to relief from ADHD symptoms and improvements in sleep.

For the current study, researchers from the University of Nebraska, Lincoln, conducted a meta-analysis of nine randomized, controlled studies involving 246 children and adolescents who were diagnosed with ADHD, had been randomly assigned to stimulants (methylphenidate and amphetamine), and had sleep assessed using objective measures.

The researchers found that youth with ADHD who took stimulants took a longer time to fall asleep, have worse sleep efficiency, and sleep for shorter periods of time. The analysis revealed that the more times a day a stimulant was taken, the longer it took for the youth to fall asleep. Additionally, while the findings revealed that stimulants had a negative effect on sleep efficiency regardless of how long the youth took the medication, sleep efficiency appeared to improve over time.

“The results of the present meta-analysis highlight the importance of carefully weighing the potential benefits and adverse effects of stimulant medications when prescribing to children,” the study authors wrote. “Pediatricians are also encouraged to provide referrals for behavioral treatment of ADHD and sleep, either in addition to or as an alternative to prescribed medications.”

For related information, see the Psychiatric News article “Children With ADHD Benefit From Sleep-Focused Treatment.”

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Judge Awarded for Work on Decriminalization of People With Mental Illness

In a ceremony yesterday evening at the United States Supreme Court, Florida Judge Steven Leifman, J.D., was honored with the 2015 William H. Rehnquist Award for Judicial Excellence from the National Center for State Courts for his work on behalf of people with mental illness in the Miami-Dade (Fla.) County criminal justice system.

Leifman, who also serves on the board of directors of the American Psychiatric Association Foundation, has both advocated for and implemented programs to divert from county jails into treatment and community support people with mental illness who do not pose a risk to public safety.

“It is important to recognize a larger American problem: the rising presence of people with mental illness in our jails and prisons even as the general prison populations declines,” said Leifman. The intersection of the criminal justice and mental health systems is “fragmented, underresourced, and outdated.”

Solving this problem cannot be accomplished by one person, one level of government, or one party, he said. “We are used to an adversarial criminal justice system, but we need to reach across boundaries.”

APA President Renée Binder, M.D., who attended the ceremony, noted that the award to Dr. Leifman highlights the national recognition by the judicial system of the inappropriate criminalization of persons with mental illness. 

"Chief Justice John Roberts listened carefully while Dr. Leifman gave an elegant and passionate speech of his experience as a sitting judge and seeing defendants with obvious mental illness and confusion who had committed minor offenses and were being sent to jail inappropriately," she said. "APA is working collaboratively with Judge Leifman and with other stakeholders to highlight this problem and address solutions."

For more in Psychiatric News about Judge Leifman’s work in Miami, see “Program Prepares Defendants for Return to the Community” and “Defendants With Mental Illness Diverted to Social Security System.”

(Image: Rick Reinhard)

FDA Extends Deadlines for Clozapine REMS Program

The Food and Drug Administration (FDA) is extending deadlines for provider and pharmacy certification for participation in the Clozapine Risk Evaluation and Mitigation Strategy (REMS).

In an announcement issued this week, the FDA said it is indefinitely extending the deadlines due to technical and other problems associated with the Clozapine REMS. New deadlines will be issued after further evaluation by the administration. “We are also carefully evaluating next steps regarding the December 14, 2015, pre-dispense authorization (PDA) launch,” the FDA said in a statement. “We will communicate the revised certification deadlines and additional information about the PDA launch as soon as possible.”

The Clozapine REMS Program replaces the individual clozapine patient registries that had been required previously for monitoring neutrophil counts in patients receiving the antipsychotic, which has been associated with a risk for agranulocytosis. The new REMS program was initiated this year in an effort to ease burdens on clinicians and pharmacies and to make clozapine—one of the most effective antipsychotics and the only drug approved for treatment-resistant schizophrenia—accessible to more patients.


The administration said the deadlines are being extended to help ensure that health care professionals have sufficient time to complete this process and that patient access to clozapine is maintained. “Health care providers should prioritize the medical needs of their patients and, as appropriate, continue prescribing and dispensing clozapine to patients with an absolute neutrophil count (ANC) within the acceptable ranges while the issues are being resolved by the Clozapine REMS program administrators,” the administration said. “Prescribers and pharmacies should continue to work with the Clozapine REMS Program administrators to resolve any issues and continue their efforts to complete certification and update patient information to meet the requirements of the program.”

APA is continuing to discuss concerns related to implementation of the Clozapine REMS program with the FDA. For information on the Clozapine REMS, click here. For further information in Psychiatric News, see “Why Won’t Clinicians Use Clozapine Despite Proven Superiority?”

Are Your 1500 Forms Being Rejected? Here’s Help!

APA has received reports that Medicare providers who file 1500 Health Insurance Claim Forms are having a large number of their claims returned due to a change in the reporting requirements that went into effect on October 1.

Medicare contractors are returning claims for correction or resubmission to mental health professionals who fail to indicate in line item 21 of the 1500 claim form whether ICD-9 or ICD-10 codes are used.

For services that were provided prior to October 1, ICD-9 codes should be used even if the claim is filed after that date; for services on or after October 1, 2015, ICD-10 codes should be used. ICD-9 codes are indicated by using a 9 in item #21; ICD-10 codes are noted with a 0.

Also, though there is some inconsistency among what payers are accepting, the general feedback that APA is receiving is that codes submitted in Item 21 should not contain a decimal point (for example, the code F43.10 should be submitted as F4310).

DSM-5 lists both the ICD-9 and the ICD-10 codes for each diagnosis. The ICD-9 codes are in black ink and the ICD-10 codes are to the right of them in gray ink.

For information about how to implement ICD-10 codes using DSM-5, see Using DSM-5 in the Transition to ICD-10.

We encourage you to provide us with feedback regarding any problems you have with the claims you file by sending an email to dsm5@psych.org. The more feedback we receive from you, our practitioners, the better we can communicate tips like the above to help ensure that your claims are accepted.

AMA Calls for Ban on Direct-to-Consumer Ads, Citing Impact on Drug Costs

The American Medical Association this week called on the Food and Drug Administration (FDA), which oversees prescription drug advertising, to ban direct-to-consumer advertising (DTCA), citing its effect on rising pharmaceutical prices. 

At the Interim Meeting of the AMA’s House of Delegates in Atlanta, earlier this week, delegates who voted for the resolution said that although DTCA may increase awareness about diseases and drugs to treat them and thereby prompt some patients to visit a physician, the ultimate goal of DTCA is to drive demand for a product, which may affect the overall cost of drugs. A number of other resolutions and reports at the meeting were devoted to the issue of escalating drug prices.

Psychiatrist and AMA Board Chair-elect Patrice Harris, M.D., M.A. (pictured left), said the vote in support of a ban on DTCA reflects concerns among physicians about the negative impact of commercially driven promotions. “Direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate,” she said. “Patient care can be compromised and delayed when prescription drugs are unaffordable and subject to coverage limitations by the patient’s health plan. In a worst-case scenario, patients forego necessary treatments when drugs are too expensive.”

The United States and New Zealand are the only two countries that allow DCTA of prescription drugs.

The AMA, in a statement about the vote, cited market research by the firm Kantar Media showing that advertising dollars spent by drug makers have increased by 30 percent in the last two years to $4.5 billion.

For more information about the resolution, see an upcoming edition of Psychiatric News. For related information on DTCA, see the Psychiatric News article “Some Worry Drug Companies Will Exploit New Media.”

(Image: Ted Grudzinski/AMA)

Bright Light Therapy Found To Be Effective in Treating Adults With MDD

Bright light therapy has been shown to be effective in people with seasonal affective disorder (SAD), but a new study published today in JAMA Psychiatry shows that this therapy may also serve as an effective treatment for nonseasonal major depressive disorder (MDD).

To examine the efficacy of light treatment alone or in combination with antidepressants for the treatment of MDD, Raymond Lam, M.D., a professor of psychiatry at the University of British Columbia, and colleagues conducted an eight-week randomized, placebo-controlled trial of adults aged 19 to 60.

A total of 122 patients with MDD were randomly assigned to one of four groups: light therapy (active white light box for 30 minutes in early morning plus placebo pill each day); antidepressant therapy (inactive negative ion generator plus fluoxetine hydrochloride (20 mg) each day; combination light and antidepressant treatment; or placebo (inactive negative ion generator plus placebo pill). The primary outcome measure was a reduction in score on the Montgomery Åsberg Depression Rating Scale (MADRS), from baseline to endpoint. Secondary outcome measures included response (greater than 50% reduction in MADRS score) and remission (MADRS score less than 10 at end point).

The results showed that light monotherapy and combined therapy was statistically superior to placebo as it relates to reduction in MADRS scores; there was no statistical difference between fluoxetine monotherapy and placebo. For the respective placebo, fluoxetine, light, and combination groups at the end point, response was achieved by 33.3%, 29.0%, 50.0%, and 75.9% and remission was achieved by 30.0%, 19.4%, 43.8%, and 58.6%.

“Bright light treatment, both as monotherapy and in combination with fluoxetine, was efficacious and well tolerated in the treatment of adults with nonseasonal MDD. The combination treatment had the most consistent effects,” noted the researchers. “Further studies exploring mediators and moderators of response will be important.”

To read more about therapies for seasonal affective disorder, see the AJP in Advance article “Outcomes One and Two Winters Following Cognitive-BehavioralTherapy or Light Therapy for Seasonal Affective Disorder.”

(Image Point Fr/Shutterstock)

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SAMHSA Seeks Chief Medical Officer to Address MH Issues at Federal Level

Here’s a rare opportunity to maximize the reach of your medical knowledge and skills by becoming a part of a federal agency that seeks to improve the mental health of all Americans. The Substance Abuse and Mental Health Services Administration (SAMHSA) is recruiting for the position of chief medical officer in its Office of Policy, Planning, and Innovation in Rockville, Md. Among the positon’s major responsibilities are advising SAMHSA’s Advisory Committee on a range of medical and scientific policy questions, providing expert advice on medical considerations and related matters that impact on program plans and/or goals, and participating in national meetings and symposia involving experts and leaders in behavioral health. Click here for more details and application information.

More Children Were Prescribed Low-Dose Antidepressants After FDA Warnings, Study Finds

Following the Food and Drug Administration’s decision in 2004 to add a black-box warning to all antidepressants due to the increased risk of suicidal thinking or behavior among children, the proportion of youth who initiated a selective serotonin reuptake inhibitor (SSRI) at a low dose grew, according to a study published Monday in Psychiatric Services in Advance.

Although several studies have noted various effects of the 2004 black-box warnings—including changes in the use of antidepressants among youth and a shift in the care of these patients from generalists to psychiatrists—the warning’s effect on dosing was unknown.

In the current study, a team of researchers from the United States and the Netherlands examined data contained in the LifeLink Health Plan Claims Database on commercially insured children (aged 5 to 17), young adults (aged 18 to 24), and adults (aged 25 to 64) who initiated an SSRI (citalopram, fluoxetine, paroxetine, or sertraline) from January 1, 2000, to December 31, 2009. Dose per day was calculated on the basis of days’ supply, strength, and quantity dispensed; dose was defined by age group and SSRI agent on the basis of available guidelines and product labels, with low dose defined as less than the recommended initial dose.

Of the 51,948 children who initiated an SSRI between 2000 and 2009, 15% initiated with a low dose before the 2004 warning compared with 31% after the warning; there was a smaller change among young adults (6 percentage points) and adults (3 percentage points). The proportion of patients initiating an SSRI with a low dose after the 2004 black-box warning compared with before the warning was most prominent among children aged 13 to 17 (37% before versus 17% after), a relative increase of 116%.

“Given recent findings that the dose of the antidepressant may be associated with an increased risk of self-harm, as well as AACAP guidelines indicating that children and adolescents with depressive disorders should initiate antidepressant treatment with a low dose, our results suggest that prescribing practices surrounding SSRI dosing among children improved following the black-box warnings but still fall short of guidelines,” the study authors wrote.

For related information, see the Psychiatric News article “Experts Debate Effects of Antidepressant Warning.”

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Early Follow Up Found to Be Key to Patient Success in Collaborative Care of Depression

Patients with depression who were contacted by a care manager at least once within four weeks of their initial visit were more likely to achieve improvements in symptoms and had a shorter time to improvement than those who were not contacted early on, according to a study of a collaborative care model (CCM) published today in Psychiatric Services in Advance. For patients who did not achieve improvements by week 8, consultation about the case between the primary care provider and the team psychiatrist by week 12 predicted improvement within six months.

According to the study authors, who were led by Jürgen Unützer, M.D., M.P.H. (pictured left), of the University of Washington, the findings of the study highlight the importance of patient engagement in the early phase of treatment and timely psychiatric consultation when patients do not experience improvement in the early phases of the collaborative care model.

The researchers analyzed outcomes for over 5,400 adult psychiatric patients who had initiated care in clinics that were part of the Mental Health Integration Program (MHIP), a publicly funded implementation of the CCM in a network of more than 100 community health centers in the state of Washington. The group examined whether care manager follow-up and psychiatric consultation were associated with clinically significant improvements in depression (defined as having at least one follow-up PHQ-9 score of less than 10 or achieving a 50% or more reduction in the PHQ-9 score within 24 weeks of initial contact).

Four-week follow-up was associated with a greater likelihood of achieving improvement in depression and a shorter time to improvement. Psychiatric consultation was also associated with a greater likelihood of improvement but not with a shorter time to improvement.

“Our findings support efforts to improve fidelity to these two process-of-care tasks and to include these two tasks among quality measures for CCM implementation,” the study authors wrote. “Future studies should seek to assess the relative importance of other key tasks of CCM and test implementation strategies (for example, pay for performance) to encourage and enable high fidelity to tasks found to contribute to good patient outcomes,” the study authors commented.

To read about some of APA’s efforts to facilitate broader use of collaborative care models, see the Psychiatric News article “APA Urges Creation of Payment Codes Specific to Collaborative Care Model.”

Risks of Adding Antipsychotics to Mood Stabilizer May Outweigh Benefits After 6 Months

Following an acute manic episode, many patients with bipolar disorder are treated with a combination of a mood stabilizer and an atypical antipsychotic to reduce the risk of a manic relapse. However, due to the side effects of antipsychotics—including weight gain and metabolic syndrome—most agree that antipsychotic therapy should be maintained only if the benefits of using the medication can be shown to outweigh the risks.

A study published last month in Molecular Psychiatry suggests six months of adjunctive antipsychotic therapy is helpful in reducing mania relapse, but beyond that there is limited benefit.

Lakshmi Yatham, M.D. (pictured above), of the Department of Psychiatry at the University of British Columbia and colleagues recruited patients with bipolar I disorder who had recently remitted from a manic episode following treatment with a mood stabilizer (lithium or valproate) and antipsychotic (risperidone or olanzapine). Patients were randomly assigned to one of three conditions: discontinuation of risperidone or olanzapine and substitution with placebo at the trial’s start (“0-week group”) or 24 weeks after entry, or continuation of the antipsychotic therapy throughout the 52-week trial.

The researchers found that patients on antipsychotics and mood stabilizers for 24 weeks following remission of their manic episode had about half the risk of relapse as patients who tapered off antipsychotics following remission (the 0-week group) and the same relapse risk as patients taking antipsychotics for the full 52 weeks. The 24-week group gained an average of 0.1 kg while the 52-week group gained an average of 3.2 kg; the 0-week group lost 0.2 kg on average.

The findings suggest that when weighing the risks and benefits of risperidone or olanzapine adjunctive therapy, 24 weeks may be the best option, Yatham told Psychiatric News.

For the complete report, click here.

(Image: Martin Dee/UBC )

Lurasidone Found to Be Safe, Effective in Patients With Mixed Forms of Major Depression

Once daily treatment with lurasidone for six weeks decreased depressive and manic symptoms in patients with mixed forms of major depression with limited adverse effects, according to a study published Tuesday in AJP in Advance.

A growing body of evidence suggests that manic symptoms below the threshold for hypomania (mixed features) are common in individuals with major depressive disorder. Little is known of the best treatment options for this form of depression, but some clinical trials have suggested that standard antidepressants may be ineffective for this condition and associated with potential treatment-related complications, including suicidal ideation and behavior, manic switch, agitation, and impulsivity.

For the current study, researchers from Stanford University and Sunovion Pharmaceuticals randomly assigned patients aged 18-75 with a major depressive disorder (based on DSM-IV-TR criteria) who also reported two to three manic symptoms for at least two weeks prior to screening to take lurasidone (20-60 mg) or placebo daily for six weeks.

Lurasidone significantly improved depressive symptoms compared with placebo, as indicated by changes from baseline in Montgomery-Åsberg Depression Rating Scale score and the Clinical Global Impressions severity subscale score. Manic symptoms were also significantly improved in the lurasidone group, and treatment with lurasidone was associated with significant improvement both in anxiety symptoms and in patient-reported functional impairment. Nausea (6.4% and 2.0% in the lurasidone and placebo groups, respectively) and somnolence (5.5% and 1.0%) were the most common adverse events reported by the study participants.

“There is a pressing need for evidence-based treatments of major depressive disorder presenting with subthreshold hypomanic symptoms (mixed features), especially given its complex course and associated morbidity,” the study authors wrote. “Treatment with lurasidone was well tolerated, with a favorable benefit-risk profile in this difficult-to-treat clinical population. Further investigation is needed to determine whether these findings are applicable to other agents in the atypical antipsychotic class.”

For related information on lurasidone’s effectiveness in treating bipolar I depression, see the Psychiatric News article “Data Released Backing Lurasidone’s New Indication.”

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Study Supports Raising SSRI Doses in Patients Who Do Not Respond to Low-Dose Treatment

Using a higher dose of selective serotonin reuptake inhibitors (SSRIs) for major depressive disorder appears to be associated with an increased likelihood of response, according to a meta-analysis published today in AJP in Advance. This benefit, which is somewhat offset by decreased tolerability of SSRIs at high doses, appears to plateau at about 50 mg of fluoxetine (250 mg imipramine-equivalent dose).

A team of researchers in the United States and London searched PubMed for randomized, placebo-controlled trials that examined the efficacy of SSRIs for treating adults with major depressive disorder and assessed improvement in depression severity at multiple time points. Additional data were collected on treatment response and all-cause and side effect-related discontinuation. All medication doses were transformed into imipramine-equivalent doses.

Based on an analysis of 40 studies involving 10,039 participants, the investigators found a statistically significant positive association between SSRI dose and measured efficacy of SSRIs in reducing depression severity, with the greatest measured efficacy of SSRIs observed in the dosing range of 200–250 imipramine equivalents. The analysis also revealed that higher doses of SSRIs were associated with an increased likelihood of dropouts due to side effects but a decreased likelihood of all-cause dropout, which the authors noted “is likely attributable to their greater efficacy.”

“Our meta-analysis provides evidence to support clinical guidelines that recommend raising SSRI dose in adults with major depressive disorder who do not respond to SSRI medications at or below the lower end of the therapeutic dose range,” the study authors wrote.

For related information, see the Psychiatric News article “Study to Answer What Comes Next When MDD Patients Don’t Respond.”

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CBT May Be More Durable Treatment for SAD Than Light Therapy

Six weeks of cognitive-behavioral therapy sessions tailored for seasonal affective disorder (CBT-SAD) may lead to longer-lasting effects than those seen with light therapy, according to a recent study in AJP in Advance.

Light therapy is a proven approach to treat acute SAD, but previous studies show that most patients fail to reinitiate light therapy in subsequent winters—leaving them vulnerable to the recurrence of depression. A recent analysis found CBT-SAD to be as effective as light therapy in alleviating depression associated with SAD, but it was unknown how long lasting these effects might be.

In the current study, researchers examined outcomes for 177 participants with SAD who were randomly assigned to receive CBT-SAD (two 90-minute sessions a week) or light therapy (30 minutes each morning) for six weeks. The participants were then assessed one and two winters later. The primary outcome was winter depression recurrence status on the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version.

In the first follow-up winter, recurrence of SAD was the same in the two groups (28.9% for CBT and 24.9% for light therapy). At the second winter, CBT-SAD had a 27.3% recurrence rate compared with 45.6% for light therapy. Participants treated with CBT-SAD also reported less severe symptoms and showed a higher rate of remission, as measured by the Beck Depression Inventory-Second Edition scores.

“Light therapy remains an important treatment for SAD, but this study shows the value of educating people about their illness and behaviors that can help manage it,” said Norman Rosenthal, M.D., a clinical professor of psychiatry at Georgetown University School of Medicine. Rosenthal, an expert on SAD, was not involved in the study.

For more on the effectiveness of CBT and light therapy for SAD, see the Psychiatric News article “CBT, Light Therapy Found Comparable for Seasonal Affective Disorder.”

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Cariprazine Found to Be Effective and Well-Tolerated for Bipolar Depression

An eight-week, randomized, controlled study published today in AJP in Advance has found that a 1.5 mg daily dose of the atypical antipsychotic cariprazine can reduce depressive symptoms in people with bipolar I disorder experiencing a major depressive episode.

Most antipsychotics are approved to treat bipolar manic or mixed episodes, but currently only lurasidone and quetiapine are approved for bipolar depression (lurasidone has not been assessed in bipolar mania and is not indicated for its treatment). Cariprazine (trade name Vraylar) was recently approved by the FDA for the acute treatment of manic or mixed episodes associated with bipolar I disorder, so if these results hold up in a larger clinical study, it could provide patients with another comprehensive medication for bipolar disorder.

In this trial, 571 participants were randomized to receive daily doses of placebo or cariprazine at 0.75 mg, 1.5 mg, or 3.0 mg for eight weeks. While there was no difference in the reduction of MADRS (Montgomery–Åsberg Depression Rating Scale) total score between the group that received cariprazine at 0.75 mg/day and the group that received placebo, the group administered cariprazine at 1.5 mg/day showed significantly greater improvement on MADRS total score change (4 points lower) after 6 weeks. The group that received cariprazine at 3.0 mg/day also showed some improvements, but these results were not statistically significant.

Cariprazine was generally well tolerated over the course of treatment. The most common adverse events in cariprazine-treated patients were akathisia and insomnia; weight gain was slightly higher with cariprazine than with placebo.

“Of the cariprazine dosages studied, 1.5 mg/day demonstrated the most robust efficacy and good safety, suggesting that it may be an effective dosage for the treatment of bipolar I depression,” the study authors wrote. “Given the limited number of positive studies for atypical antipsychotics in bipolar I depression, future studies are warranted to extend these phase II findings.”

For related information, see the Psychiatric News articles “Cariprazine Joins Growing Group of Approved Antipsychotics” and “As FDA Decision Nears, Cariprazine Collects More Proof of Efficacy.”

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Milestone Reached as Subcommittee Passes Comprehensive MH Reform Bill

A House subcommittee yesterday passed the Helping Families in Mental Health Crisis Act of 2015 (HR 2646), a major step on the road to comprehensive mental health reform.

“We are very pleased by Wednesday night’s passage of HR 2646 by the House Energy and Commerce Health Subcommittee,” said APA President Renée Binder, M.D., in a statement. “This bill goes a long way in addressing the shortcomings of our nation’s broken mental health system.”

The bill, which is cosponsored by 117 Republicans and 45 Democrats, includes provisions to expand options for care, boost Medicaid funding for mental health services, augment the mental health workforce, and increase the number of inpatient psychiatric beds. The bill would also overturn existing restrictions preventing Medicaid from paying for same-day general and mental health care and from covering care at psychiatric facilities with more than 16 beds.

Additionally, HR 2646 contains many top-tier APA priorities, including these:

* A number of meaningful psychiatric workforce development provisions.
* Provisions related to enforcement of the landmark Mental Health Parity and Addiction Equity Act.
* Enhanced authorized funding for research activities within NIMH.
* Stronger coordination of federal mental health resources across departments and agencies, and requirements for mental health clinician leadership at the highest levels.

Rep. Murphy’s “amendment in the nature of a substitute” (AINS) included a number of modifications and refinements to the bill that he originally introduced in June in response to concerns of some committee Democrats and outside stakeholders. For example:

* The AINS added language to make it more clear that states would receive a bonus for having Assisted Outpatient Treatment (AOT) programs and states would not be penalized for not adopting AOT.
* The AINS considerably streamlined HR 2646’s proposed Health Insurance Portability and Accountability Act (HIPAA) provision.

While the vote was bipartisan, most committee Democrats voted against the bill. The 18-12 vote reflected concerns by Democrats about several points in the bill, including changes in HIPAA that they fear would reduce privacy protections and the potentially coercive effects of incentives for states to pass AOT laws.

“APA would like to thank Rep. Tim Murphy, Rep. Eddie Bernice Johnson, and the 161 other cosponsors of this important legislation,” said APA CEO and Medical Director Saul Levin, M.D., M.P.A. “This bill has broad bipartisan support because members of both parties realize now is the time to fix our nation’s mental health system.”

No date has been set yet for the full committee to consider the bill.

“We will continue to work with our partners and with members on both sides of the aisle to pass this legislation in the House,” added Binder. “We encourage the full committee to act on this bill soon.”

For more in Psychiatric News about the Helping Families in Mental Health Crisis Act of 2015, see “APA Joins in Push to Advance MH Legislation Through Congress.”

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Cardiovascular, Respiratory Disease Among Top Causes of Death in Adults With Schizophrenia

A recent study published in JAMA Psychiatry reports that adults with schizophrenia die at 3.5 times the rate of the general U.S. population. While this increased risk of mortality was distributed across multiple diseases, it was particularly elevated for cardiovascular disease, diabetes mellitus, and suicide.

“The findings… highlight the need to focus on interventions that target lifestyle risk factors such as smoking and poor diet, treat medical risk factors such as hypertension and hypercholesterolemia, and assertively manage physical comorbidities such as diabetes mellitus and cardiovascular disease,” wrote John McGrath, M.D., Ph.D., of the Queensland Centre for Mental Health Research and colleagues in a related editorial.

For the study, researchers from Columbia University and Rutgers University examined data from more than 1 million Medicaid patients aged 20 to 64 with schizophrenia collected from 2001 to 2007; this included 74,003 deaths, of which 65,553 had a known cause.

Among the 65,553 deaths over the study period, 55,741 were from natural causes, with cardiovascular disease having the highest mortality rate (403.2 per 100,000 person-years), accounting for almost one-third of all natural deaths. Cancer had the second highest mortality rate (200.5 per 100,000 person-years), with lung cancer being the most prevalent cause of death by cancer (74.8 per 100,000 person years). Other leading causes of natural death in people with schizophrenia included chronic obstructive pulmonary disease (89.5 per 100,000 person-years) and diabetes (61.8 per 100,000 person-years).

Unnatural causes of death accounted for 9,812 deaths, with suicide accounting for about one-quarter of these deaths. Nonsuicidal substance-induced death, mostly from alcohol or other drugs, was also a leading cause of death (95.2 per 100,000 person-years).

“The results from this study confirm a marked excess of deaths in schizophrenia, particularly from cardiovascular and respiratory disease, that is evident in early adulthood and persists into later life,” the study authors concluded. “These findings support efforts to train mental health care professionals in tobacco use prevention and treatment and in implementation of policies that incentivize smoking control interventions in settings treating patients with schizophrenia.”

For related information, see the Psychiatric News article “What Can Psychiatrists Do for People With SMI?” and the Psychiatric Services article “Use of Active-Play Video Games to Enhance Aerobic Fitness in Schizophrenia: Feasibility, Safety, and Adherence.”

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Continued Low Rate of Clozapine Use and Wide Variability Found in State Medicaid Programs

Clozapine continues to be dramatically underutilized—despite it being the only drug approved for treatment-resistant schizophrenia—and there appears to be significant variation among states in its use for patients in the Medicaid program.

That’s the finding from an analysis of Medicaid data in 46 states published Monday in Psychiatric Services in Advance. Mark Olfson, M.D., M.P.H. (pictured left), of Columbia University and colleagues updated a previous analysis from 2001 to 2005 to include data from 2006 to 2009.

Overall, clozapine accounted for 4.8% of antipsychotic use in schizophrenia from 2006 to 2009, with a slight decline during this period (5.7% in 2006 to 4.3% in 2009). Clozapine was least commonly used in the Deep South (Louisiana, Mississippi, and Alabama) and more commonly used in New England, the Rocky Mountain West, and Washington. The highest rate of clozapine prescribing was in South Dakota (15.6%) and the lowest was in Louisiana (2.0%).

The authors of the analysis noted several factors associated with low clozapine use: fiscal stress, inadequate staffing to monitor clozapine, patient reluctance about blood monitoring, and concerns over tolerability.

Recently, the Food and Drug Administration issued modifications to its requirements for blood monitoring for patients receiving clozapine in an effort to lessen the burden on clinicians and patients. “I think the new monitoring system will be quite helpful,” Olfson said in comments to Psychiatric News. “It simplifies the clinical evaluation of neutropenic events, increases access to clozapine for patients with benign neutropenia, and permits those who develop mild neutropenia to continue treatment.”

For related information, see the Psychiatric News article “Why Won’t Clinicians Use Clozapine Despite Proven Superiority?”

Infants Exposed to Antidepressants May Experience Effects for Up to a Month After Delivery

Pregnant women with major depressive disorder face a challenging decision when considering treatment over the course of their pregnancy. While there is evidence to suggest infants born to mothers whose depression goes untreated can experience behavioral problems, studies have also found that infants exposed to selective serotonin reuptake inhibitors (SSRIs) may experience adverse behavioral symptoms that typically resolve within the first two weeks following birth.

A study published in AJP in Advance now suggests some infants exposed to SSRIs and benzodiazepines may continue to experience the effects of the medications throughout their first month of life.

Researchers at Brown University assessed 184 pregnant women at two points during their pregnancy and classified them into four groups: no exposure, depression only (no medication taken), SSRI exposure, and SSRI plus benzodiazepine exposure. The infants born to these women were then examined with a structured neurobehavioral assessment (Neonatal Intensive Care Unit Network Neurobehavioral Scale) in the first week after delivery, with follow-up assessments on days 14 and 30.

Infants in the SSRI and SSRI plus benzodiazepine groups had lower movement quality and more CNS stress signs across the first postnatal month compared with infants in the no exposure or depression groups; there were no differences seen whether or not the mother discontinued SSRI use in the third trimester. In addition, infants in both SSRI groups showed lower self-regulation and higher arousal at day 14 compared with the other two groups. Infants in the SSRI plus benzodiazepine group had the least favorable scores on the Neonatal Intensive Care Unit Network Neurobehavioral Scale.

“In agreement with the current practice guidelines of the American Psychiatric Association and the American College of Obstetricians and Gynecologists, these findings do not support discontinuing SSRI medication in the third trimester of pregnancy for those women who have been successfully managing their depressive symptoms with SSRIs throughout pregnancy,” the study authors wrote. “Furthermore, our data suggest that concomitant use of benzodiazepines in conjunction with SSRIs is associated with more significant problems in infant neurological functioning than SSRI use alone. This may be a result of the underlying disorder and symptom severity or the neonate’s inefficiency in metabolizing multiple drugs.”

For related information, see the Psychiatric News article “Study Reports on Risks, Benefits of SSRIs Taken During Pregnancy.”

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