Friday, April 17, 2015

Brexpiprazole Found Safe, Effective for Patients With Schizophrenia, AJP Reports


New findings from a phase 3 clinical trial, published today in AJP in Advance, suggest that a recently developed antipsychotic may prove to be one of the next treatments for schizophrenia.

Researchers from the Department of Psychiatry at Hofstra North Shore-LIJ School of Medicine conducted a randomized, double-blind, placebo-controlled study with 636 patients with schizophrenia to investigate the efficacy, safety, and tolerability of brexpiprazole—a  serotonin-dopamine activity modulator that acts as a partial agonist at serotonin 5-HT1A receptors and dopamine D2 receptors, while antagonizing serotonin 5-HT2A receptors and noradrenaline alpha receptors. 

The results showed that after six weeks of treatment, patients taking 2 mg and 4 mg of brexpiprazole had, respectively, Positive and Negative Syndrome Scale scores approximately 9 and 8 points lower than that of the placebo group. Weight gain from baseline was found to be moderate among the active groups, with the 2 mg cohort gaining an average of 1.45 kg and the 4 mg cohort gaining 1.28 kg. The most common treatment-emergent adverse event reported for brexpiprazole was akathisia, at a rate of 4.4 percent in the 2 mg cohort and 7.2 percent in the 4 mg cohort. No clinically or statistically significant changes were observed from baseline in lipid and glucose levels and extrapyramidal symptom ratings.

“Schizophrenia is a complicated disease, and while advances have been made, patients often still lack an effective treatment path,” the study’s lead author, Christoph Correll, M.D., a professor of psychiatry at Hofstra, told Psychiatric News. “It is important for clinicians and patients to have a range of treatment options to manage symptoms effectively and safely ... as response to therapy can vary greatly from individual to individual and from one medication to the next.” Correll informed Psychiatric News that the Food and Drug Administration will make its final decision about the approval of brexpiprazole for the treatment of schizophrenia as well as major depressive disorder in July.

The research was funded by Otsuka Pharmaceuticals, the manufacturer of brexpiprazole.

To read about the pipeline for psychotropic medications, see the Psychiatric News article “Candidates, Innovation Missing From Psychotropic Drug Pipeline.”

(Image: Vashchig/shutterstock.com)

Thursday, April 16, 2015

Comorbid Depression, Type 2 Diabetes Associated With Increased Risk of Dementia, Study Finds


Researchers have known for some time that a diagnosis of depression or type 2 diabetes mellitus (DM) may increase a patient's risk for dementia later in life. Now, a study published online in JAMA Psychiatry on April 15 finds people diagnosed with both are at an even higher risk for dementia.

Dimitry Davydow, M.D., M.P.H., an associate professor of psychiatry and behavioral sciences at the University of Washington School of Medicine, and colleagues analyzed data on more than 2.4 million Danish citizens, 50 years or older, who were free of dementia from January 1, 2007, through December 31, 2013, to estimate the risk of all-cause dementia associated with DM, depression, or both. Within this population, 477,133 (19.4 percent) had been diagnosed with depression, 223,174 (9.1 percent) with DM, and 95,691 (3.9 percent) with both.

The researchers found that over the course of the study, 59,663 participants (2.4 percent) developed dementia, and of these, 6,466 (10.8 percent) had DM, 15,729 (26.4 percent) had depression, and 4,022 (6.7 percent) had both. Compared with people without depression or DM, the authors reported that DM alone was associated a 20 percent greater risk of dementia, depression alone was associated with an 83 percent greater risk, and comorbid depression and DM were associated with a 117 percent greater risk, after adjusting for such factors as age, sex, and marital status. For those under 65 years with depression and DM, the risk for dementia appeared to be even greater.

"Given that depression in patients with DM is associated with poor self-care, nonadherence to treatment regimens, and adverse psychobiological changes, this younger group with comorbid depression and DM may be vulnerable to developing dementia later in life," the authors wrote. "From a public health perspective, developing screening and interventions to improve the quality of treatment of depression and DM in this subgroup of patients could be important in reducing the risk for dementia.”

For more on the association between diabetes and mental disorders, see the Psychiatric News article “Link Seen Between Mental Disorders, Diabetes in New Study.”

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Wednesday, April 15, 2015

SGR Finally Repealed in Historic Senate Vote


Congress repealed the sustainable growth rate (SGR) component of the Medicare payment formula last night when the U.S. Senate voted 92-8 to approve the Medicare Access and CHIP Reauthorization Act. The legislation, which was approved by the House of Representatives two weeks ago, will now go to President Obama, who has already indicated he will sign it.

The new law permanently repeals the flawed SGR reimbursement formula, after more than a decade of efforts by APA, the AMA, and other physician groups. Without action, physicians would have faced a 21 percent across-the-board payment cut beginning April 15.

The SGR is a budget cap that was passed into law in 1997 as an attempt to control federal spending on physician services. Since 2003, Congress has routinely delayed devastating cuts that would have jeopardized beneficiary access to psychiatric services in the Medicare program through “patches” to scheduled SGR reductions, causing significant instability and administrative burden for physician practices.

The new law will provide a stable period of annual updates of 0.5 percent now through 2019. The 2019 rate is maintained through 2025, with the potential for additional adjustments through the creation of the new Merit-Based Incentive Payment System. Beginning in 2019 and ending in 2024, physicians may instead make themselves eligible for a 5 percent incentive payment based on participation in certain alternative payment models (APMs). In 2026, physicians who participate in these APMs will receive a 1 percent annual update, while all other physicians will receive a .5 percent annual update. The law also reauthorizes the Children’s Health Insurance Program for two years.

“Senate passage of the SGR reform bill is a major step toward a reliable and rational payment system for Medicare beneficiaries and their physicians. It is long overdue,” said APA President Paul Summergrad, M.D. “APA, our members, and the entire medical community advocated strongly for this legislation, which will eliminate uncertainty from the Medicare system to make sure patients and families can get the care they need and deserve from their physicians.”

“Repealing the SGR has been a decades-long process that has involved the advocacy of thousands of APA members and other medical experts--a grassroots effort that will truly benefit both patients and physicians,” said APA CEO and Medical Director Saul Levin, M.D., M.P.A. “I commend the President and Congress for their leadership and efforts in this process.”

Look to Psychiatric News for full coverage of the new law. A summary of the legislation is posted on APA’s website.

(Image: Allison Hancock/shutterstock.com)

Tuesday, April 14, 2015

APA Members Urged to Contact Senators in Support of SGR Reform Bill


Legislation with the best chance in years to repeal the sustainable growth rate (SGR) component of the Medicare physician payment formula is awaiting Senate action this week. APA members are urged to contact their senators and express support for the Medicare and CHIP Reauthorization Act.

A House bill was approved two weeks ago by a wide margin just before Congress broke for its spring recess, but the Senate deferred action until after the break. If the Senate does not act this week, physician Medicare payments could be cut by 21 percent after April 15.

The Medicare and CHIP Reauthorization Act would permanently repeal the complex formula, along with the scheduled 21 percent physician pay cut.

“We support this long-overdue reform of the Medicare payment formula and elimination of the SGR,” said APA President Paul Summergrad, M.D. “The physician payment system needs to be stabilized for the sake of our patients and for our physicians who care for them.”

APA CEO and Medical Director Saul Levin, M.D., M.P.A., noted that APA’s Division of Government Relations has worked diligently over the years with the AMA and other physician organizations for payment reform. “APA strongly supports the bipartisan House-passed legislation and will continue to partner with the AMA and other medical societies to urge all senators to vote yes to send the bill to President Obama, who has already said he would sign it.”

To send a message to your senators, click here.

For the latest information on the legislation, see the Psychiatric News article "SGR Repeal Bill Passes House, Awaits Senate Action." 

(Image: Allison Hancock/shutterstock.com)

Monday, April 13, 2015

CBT Comparable to Light Therapy for Seasonal Affective Disorder, Study Finds


Cognitive behavioral therapy (CBT) is just as effective as light therapy for treating seasonal affective disorder (SAD), according to a study published online in AJP in Advance, “Randomized Trial of Cognitive-Behavioral Therapy Versus Light Therapy for Seasonal Affective Disorder: Acute Outcomes.”

While it is known that many people with SAD respond to light therapy, few studies have examined the effectiveness of other therapies. In the current study, Kelly Rohan, Ph.D., a professor of psychology at the University of Vermont, and colleagues assigned 177 adults with an episode of major depression recurrent with a seasonal pattern to receive six weeks of CBT (two 90 minute sessions per week) or light therapy (30 minute session each morning). Depression severity was measured throughout the study by two different methods: the Structured Interview Guide for the Hamilton Rating Scale for Depression–SAD Version (SIGH-SAD) and Beck Depression Inventory–Second Edition (BDI-II).

The researchers found that both treatments produced a significant and comparable response, with about half of the patients in each treatment arm reaching criteria for remission.

"These findings suggest that CBT-SAD and light therapy are comparably effective treatment modalities for targeting acute SAD," the study authors write. "Accordingly, CBT-SAD should be disseminated into practice and considered as a viable alternative to light therapy in treatment decision making."

To read about how CBT can be effective in the treatment of childhood anxiety disorder, see the Psychiatric News article, “CBT for Child Anxiety May Confer Long-Term Protection From Suicidality.”

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Friday, April 10, 2015

Rates of ADHD Lower in Areas of High Altitude, Study Finds


High altitude may serve as a protective factor against attention-deficit/hyperactivity disorder (ADHD), according to a study in the Journal of Attention Disorders.

Researchers from the Department of Psychiatry at the University of Utah analyzed data from the 2007 National Survey of Children's Health report and 2010 National Survey of Children with Special Health Care Needs report to identify and compare the prevalence of ADHD diagnoses among youth aged 4 to 17 living in the 48 adjoining states and the District Columbia.

The researchers found that states with higher than average elevations were most likely to have lower ADHD diagnosis rates, with every one foot increase in average elevation above sea level decreasing diagnosis rates by 0.001 percent. Nevada, which has an average elevation of 5,517 feet above sea level, had the lowest percentage of ADHD diagnoses at 5.6 percent, followed by Utah at 6.7 percent. ADHD diagnoses were more prevalent in states with average elevations less than 1,000 feet above sea level, with North Carolina—869 feet above sea level—having the highest diagnoses rates at 15.6 percent.

The researchers speculate that the decreased rate of ADHD may be due to higher levels of dopamine produced as a reaction to hypobaric hypoxia—a condition caused by breathing air with less oxygen at higher elevations. Decreased dopamine levels have been associated with ADHD so when levels of the neurotransmitter increase with elevation, the risk for getting the disorder diminishes, the study noted.

Coauthor Perry Renshaw, M.D., Ph.D., M.B.A., a professor of psychiatry at the University of Utah, emphasized that the current findings are not implying that people should start moving to the mountains to decrease the risk for ADHD in children. However, the research results do have potential implications for treating the disorder, which may involve increasing dopaminergic activity.

To read more about other environmental factors that have been suggested to affect rates for ADHD, see the Psychiatric News article "Sunbaked Regions Often Show Lower ADHD Prevalence."

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Thursday, April 9, 2015

APA Commends President Obama’s Call to Ban Reparative Therapy for LGBT Youth


President Obama on Wednesday called for a ban to therapies aimed at “repairing” gay, lesbian, bisexual, and transgender youth in response to the recent death of a transgender youth by suicide following what she reported were efforts by her therapist to convert her back into a boy.

In a White House statement posted on Wednesday alongside a WhiteHouse.gov petition that was started following the death of 17-year-old transgender youth Leelah Alcorn, President Obama's senior adviser Valerie Jarrett wrote, “As part of our dedication to protecting America’s youth, this Administration supports efforts to ban the use of conversion therapy for minors.”

APA has long recognized the dangers of so-called reparative therapies. In a 2000 position statement, the Association reaffirmed its opposition to “any psychiatric treatment, such as ‘reparative’ or ‘conversion’ therapy, that is based on the assumption that homosexuality per se is a mental disorder or is based on the a priori assumption that the patient should change his or her homosexual orientation." APA noted that there were “sparse scientific data about selection criteria, risks versus benefits of the treatment, and long-term outcomes of ‘reparative’ therapies.” Moreover, these therapies are at odds with APA’s position that sexual orientation is not a mental disorder.

“We applaud President Obama for his principled and scientific stand," said APA CEO and Medical Director Saul Levin, M.D., M.P.A. "LGBT individuals deserve treatment, when they seek it, that meets the highest standard of evidence, and APA has long recognized that so-called reparative therapy doesn't meet that standard and can, in fact, be hazardous. We are pleased that the White House shares our concern about this issue, and we support the President's call for a ban on reparative therapy.”

Yesterday, in an early report in the New York Times, the newspaper had stated that President Obama was calling for an end to “psychiatric therapies" aimed at "repairing" gay, lesbian, and transgender youth. APA reacted quickly to the erroneous statement that reparative or conversion therapies are “psychiatric therapies" by contacting The New York Times. The newspaper posted an updated report by mid-evening that dropped the reference to “psychiatric therapies."

(Image: shutterstock.com/Drop of Light)

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