Tuesday, May 3, 2016

Antidepressant Brintellix to Be Marketed as Trintellix Beginning in June 2016

Beginning next month, the antidepressant Brintellix (vortioxetine) will be marketed in the United States under the name Trintellix, according to a statement released yesterday by Takeda Pharmaceuticals, which holds the license to market the drug in the United States, and Lundbeck, which manufactures the drug. This brand name change, which has been approved by the Food and Drug Administration, is in an effort to decrease the risk of prescribing and dispensing errors resulting from name confusion with the anti-blood clotting medication Brilinta (ticagrelor).

“Though the original name was fully screened prior to launch, after learning about name confusion issues with Brintellix and Brilinta, we quickly took action to educate health care professionals and pharmacies about the potential for name confusion,” Thomas Harris, vice president of global regulatory affairs at Takeda, said in a statement. “Takeda and Lundbeck then proactively worked with the FDA and decided to change the name of our product as we believe this action will help minimize future risk of patients inadvertently receiving the incorrect medication.”

The companies emphasized that vortioxetine itself—formulation, dosing, and recommended usage—are unchanged. During the transition period this summer, health care providers can still prescribe, and patients will still have access to, the product under its current brand name. To reduce the risk of name confusion during this transition, the FDA recommends prescribers include the generic name of the medication they are ordering.

Last year, the Food and Drug Administration issued a warning to health care professionals and patients concerning reports of confusion between Brintellix and Brilinta because of their similar brand names. At that time, the FDA said there had been no reports that any patients had ingested the wrong medication, but the agency did say there were reports of prescribing and dispensing errors.

For related information, see the Psychiatric News article “Psychopharmacologists Seek New Nomenclature for Psychiatric Drugs.”

(Image: iStock/Oxford)

Monday, May 2, 2016

FDA Approves First Medication for Psychosis Associated With Parkinson’s Disease

The Food and Drug Administration (FDA) on Friday approved Nuplazid (pimavanserin) tablets, the first medication approved in the United States to treat psychosis in patients with Parkinson’s disease.

Although Parkinson’s disease is recognized as a movement disorder, the disease is sometimes preceded and frequently accompanied by other cognitive and psychiatric features. Some studies suggest that up to 50% of all patients with Parkinson’s disease will experience hallucinations or delusions at some time during the course of their illness—believed to be in part due to the elevated dopamine levels produced by common Parkinson’s disease medications.

Efforts to treat PDP with antipsychotics commonly prescribed for schizophrenia to date have proven mostly futile (PDP patients taking clozapine experienced worsening Parkinson’s disease symptoms; PDP patients taking quetiapine experienced fewer side effects, but the medication has yet to be proven to be more effective than placebo in these patients). However, pimavanserin is a selective-serotonin inverse agonist that preferentially targets 5-HT2A receptors, while avoiding activity at dopamine and other receptors commonly targeted by antipsychotics.

The FDA’s decision to approve pimavanserin was based on the results of a trial in which adults with PDP were randomly assigned to take 40 mg of pimavanserin or placebo daily for six weeks. Patients taking pimavanserin experienced fewer and less severe hallucinations and delusions without worsening the primary motor symptoms of Parkinson’s disease. The most common adverse effects reported by patients taking pimavanserin included peripheral edema, nausea, and confusional state, according to Acadia Pharmaceuticals Inc., the manufacturer of the medication.

As with other atypical antipsychotic drugs, the FDA noted that Nuplazid will feature a boxed warning indicating the increased risk of death associated with the use of antipsychotics in patients with dementia-related psychosis. Additionally, Nuplazid is not recommended in patients with severe renal impairment.

“[The] approval of Nuplazid represents a major paradigm shift in the treatment of Parkinson’s disease psychosis,” Michael S. Okun, M.D., medical director of the National Parkinson Foundation, said in a press release. “Through its novel and selective mechanism of action, Nuplazid is a breakthrough treatment that works in a whole new way—treating hallucinations and delusions without blocking dopamine receptors and, therefore, not impairing motor function in Parkinson’s psychosis patients.”

According to Acadia, Nuplazid will be commercially available next month.

For related information, see the Psychiatric News article “Will Nuplazid Offer a ‘New’ Choice for Treating Parkinson’s Disease Psychosis?

Friday, April 29, 2016

CMS Proposes New Rule for Quality Payment Program Under MACRA

The Centers for Medicare and Medicaid Services (CMS) has issued a 962-page proposed rule covering implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The goal, said CMS in a statement, is “a new framework for rewarding health care providers for giving better care, not just more care.”

MACRA replaces the flawed Medicare sustainable growth rate (SGR) formula and modifies and streamlines related quality reporting and electronic health record (EHR) programs. In its place now are two pathways for payment: through the Merit-Based Incentive Payment System (MIPS) or Alternative Payment Models (APMs).

Beginning with reporting in 2017, physicians will receive a composite performance score (CPS) based on how they perform in comparison to an average for other professionals. The CPS will determine maximum payment bonuses and penalties, which will range from 4% in 2019 to 9% starting in 2022. The program measures providers on the basis of quality, resource use, clinical practice improvement, and meaningful use of certified EHR technology (now referred to advancing care information).

Physicians who have sufficient revenue tied to “eligible” APMs can qualify for 5% bonuses and exemption from MIPS reporting requirements. APMs include accountable care organizations, patient-centered medical homes, and bundled payment models.

Aspects of the rule that may be relevant for psychiatry include exemption of “low-volume” providers from MIPS reporting or penalties, the ability of small practices to join together for joint reporting and assessment, flexibility for scoring within MIPS categories, and funding for technical assistance for small practices. There are also advantages for doing MIPS reporting through clinical data registries. APA is now beginning work on the development of a mental health clinical data registry.

“APA supports providing quality care to our patients,” said APA CEO and Medical Director Saul Levin, M.D., M.P.A. “The APA administration will be analyzing the rule and sharing with our membership how it will affect psychiatric care. We will also provide our members with the tools they will need to meet the new requirements.”

CMS will accept comments on the rule until June 27, and a final rule is expected to be issued by November 1.

For more information, see a brief summary of the rule and a fact sheet with links to additional information.

For more in Psychiatric News about MACRA, see “Value-Based Payment Will Change Practice, Reimbursement.

Thursday, April 28, 2016

Study Shows Importance of Monitoring Mental Health of Cancer Patients

Patients with cancer may be at a heightened risk of some mental disorders immediately before and after being diagnosed with cancer, according to a study appearing today in JAMA Oncology. The findings, according to the study authors, support the need to be attentive to the mental health needs of this patient population starting at the time of cancer diagnostic workup.

Psychiatric comorbidities, such as depression, anxiety, and substance use disorder, are common among patients with cancer. While numerous studies have examined the short- and long-term impact of a cancer diagnosis on mental health, less is known of the mental health impact of diagnostic testing leading to a cancer diagnosis.

To investigate risk changes in several mental health disorders from cancer diagnostic workup to postdiagnosis, Donghao Lu, M.D., of the Karolinska Institutet and colleagues conducted a matched cohort study of people in Sweden from January 2001 through December 2010, totaling 304,118 patients with cancer and more than 3 million cancer-free individuals randomly selected for comparison.

On the basis of  information contained in several Swedish health registers, the authors estimated the time-varying hazard ratios (HRs) of the first clinical diagnosis (made during inpatient or outpatient hospital visit) of depression, anxiety, substance abuse, somatoform/conversion disorder, and stress reaction/adjustment disorder from two years before cancer diagnosis, through the time of diagnosis, and until 10 years after diagnosis. The use of psychiatric medications for patients with cancer was also examined to assess milder mental health conditions and symptoms.

The relative rate for all studied mental disorders started to increase from 10 months before cancer diagnosis (HR=1.1) and peaked during the first week after diagnosis (HR=6.7). Although the rate increase dropped rapidly after this period, the rate remained elevated 10 years later. The rate increase immediately before and after cancer diagnosis was greater among women than men. Among patients with cancer, depression had the highest cumulative incidence during the study, followed by anxiety and stress reaction/adjustment disorder.

Additionally, the authors found that there was increased use of psychiatric medications from one month before cancer diagnosis that peaked about three months after cancer diagnosis and remained elevated two years after diagnosis.

“Although our findings highlight the importance of timely psychological intervention throughout the cancer diagnosis, it remains to be explored whether or not such intervention should be specifically tailored for patients with cancer compared with individuals without such life-threatening conditions,” the authors wrote.

For related information, see the Psychiatric News column "Integrated Psychosocial Care for Cancer Patients” by Jesse Fann, M.D., M.P.H., of the University of Washington.

(Image: iStock/KatarzynaBialasiewicz)

Wednesday, April 27, 2016

Mindfulness-Based Cognitive Therapy May Reduce Relapse in MDD Patients

A meta-analysis published today in JAMA Psychiatry suggests that mindfulness-based cognitive therapy (MBCT) may be just as or more effective in preventing or delaying relapse in patients with recurrent major depressive disorder (MDD) than other types of depression therapies, especially in individuals with pronounced residual symptoms.

MBCT combines the concepts of cognitive therapy with meditative practices and attitudes based on the cultivation of mindfulness.

“Relapse prevention in recurrent depression is a significant public health problem, and antidepressants are the current first-line treatment approach,” wrote an international team of study authors. “Identifying an equally efficacious nonpharmacological intervention would be an important development.”

For the study, the researchers performed a systematic review of randomized trials published from November 2010 to November 2014. To meet inclusion, studies were required to have compared the effectiveness of MBCT with at least one non-MBCT treatment, such as antidepressant treatment and cognitive psychological education, to prevent symptom relapse in adults with recurrent MDD who were in full or partial remission.

The effectiveness of MBCT treatment was measured by the absence of relapse to depression within 60 weeks of follow-up, measured by the Structured Clinical Diagnostic Interview. The researchers also examined the impact of sociodemographic factors and psychiatric variables on MBCT effectiveness.

Nine trials met inclusion in the meta-analysis, with a total of 1,258 participants. Of the participants who received MBCT, 38 percent had a depressive relapse within the 60-week follow-up, compared with 49 percent among those who did not receive MBCT. Results also showed MBCT to be more effective in people presenting greater depressive symptoms at baseline, compared with those who did not. There was no statistical correlation between MBCT and age, sex, education, or relationship status.

In an accompanying editorial, Richard Davidson, Ph.D., founder of the Center for Healthy Minds at the University of Wisconsin-Madison, wrote that “the opportunity now is to examine in more detail which types of patients benefit most from MBCT, the mechanisms by which MBCT is producing its beneficial change, and how we can better measure the mediators of therapeutic change.”

For related information, read the Psychiatric News article "Mindfulness Program Found to Help Urban Children Cope With Stress."


Tuesday, April 26, 2016

Meta-Analysis Suggests Nutraceuticals May Be Effective Adjuncts to Antidepressants

Several commercially sold “nutraceutical” compounds—including S-adenosylmethionine (SAMe), methylfolate, omega-3, and vitamin D—may be effective adjuncts to antidepressants for reducing depressive symptoms, according to a meta-analysis published today in AJP in Advance.

Australian and American investigators searched the literature up to December 2015 for clinical trials that examined any adjunctive nutrient-based intervention for depression and identified 40 studies (31 were randomized, double-blind, and placebo-controlled trials) for analysis. Common trial lengths were 4, 6, and 8 weeks, with a mean sample size of 63 participants and a mean age of 44 years for analysis; a variety of antidepressant pharmacotherapies were used in the studies, which primarily used open inclusion of all SSRIs or commonly specified prescription of fluoxetine, citalopram, or escitalopram.

Statistical analysis revealed a positive effect of the adjunctive intervention in 68% of the clinical trials. The authors reported positive results for replicated studies testing S-adenosylmethionine (SAMe), methylfolate, omega-3 (primarily EPA or ethyl-EPA), and vitamin D, with positive isolated studies for creatine, folinic acid, and an amino acid combination. Mixed results were found for zinc, folic acid, vitamin C, and tryptophan, with nonsignificant results for inositol.

“All of the nutraceuticals reviewed in this article have mechanistic antidepressant activity underpinning their use,” the authors wrote. For instance, omega-3 appears to exert “antidepressant activity potentially through modulation of norepinephrine, dopamine, and serotonin reuptake, degradation, synthesis, and receptor binding; through enhancement of glutathione antioxidant capacity; and through enhancement of cell membrane fluidity.” The anti-inflammatory properties of the compounds examined may also contribute to their antidepressant efficacy, the researchers added.

“Nutraceutical applications in psychiatry are advancing, as reflected in recent international collaborative consensus and position statements discussing the potential of nutraceutical use in psychiatry,” the researchers stated. “[M]uch more work is needed, and while an evolving body of research is strengthening the potential of nutraceuticals (and dietary considerations) as an important element in modern psychiatric practice, we are only beginning to study their potential applications.”

For related information, see the Psychiatric News article “Food May Be a Tool to Consider When Helping Psychiatric Patients.”

(Image: iStock/Bet_Noire)

Monday, April 25, 2016

Study Suggests Heavy Cannabis Use Early in Life May Increase Risk of Death

A Swedish study that followed men from the time of military conscription up to age 60 has found that those with a history of heavy cannabis use early in life had a higher risk of death at follow-up than those who never used the drug. The findings were published online Friday in AJP in Advance.

For the longitudinal study, Edison Manrique-Garcia, M.D., Ph.D., of the Karolinska Institutet in Stockholm and colleagues tracked the outcomes of 50,373 men aged 18 to 19, who completed a questionnaire on use of alcohol, tobacco, and other substances at the time of enlisting. Deceased cohort members up to age 60 were identified during the follow-up through the National Cause of Death Register, and overall mortality in the cohort was assessed according to information on the level of cannabis use obtained from the survey at conscription.

A total of 3,918 died during the 42 years of follow-up. Of those who died, 651 (17%) had reported cannabis use at conscription. Subjects with a baseline history of heavy cannabis use had a significantly higher risk of death (hazard ratio=1.4) than those without such a history. The authors found an excess mortality among subjects with psychotic disorders, but the level did not differ between those with a history of cannabis use (ever users: hazard ratio=3.8; heavy users: hazard ratio=3.8) and those without such a history (hazard ratio=3.7). No interaction effect was observed between cannabis use and diagnosis of psychotic disorders with regard to mortality.

“The study is convincing in its finding of increased mortality among those who used cannabis moderately to heavily prior to age 19,” A. Eden Evins, M.D., M.P.H., an associate professor of psychiatry at Harvard Medical School and director of the Massachusetts General Hospital Center for Addiction Medicine, told Psychiatric News. “It will be important now to better understand the causal pathway for the effect of early cannabis use on mortality, particularly whether it is through increased rates of cannabis addiction, which is far more common among those who initiate regular cannabis use in adolescence, other addictions such as alcohol or tobacco, or through other somatic illnesses such as cardiovascular or pulmonary disease,” said Evins, who was not involved in the Swedish study.

For related information, see the Psychiatric News article “Research Identifies Gene Linked to Cannabis-Induced Psychosis.”

(Image: iStock/nicole waring)


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