Wednesday, October 30, 2013

Company Releases Data on FDA-Approved Treatment for Bipolar I Depression

In July, lurasidone—a dopamine receptor 2 (D2) blocker originally approved to treat schizophrenia—was approved by the Food and Drug Administration (FDA) to treat depression associated with bipolar I disorder. Today in AJP In Advance, lurasidone's developers showed in their study titled "Lurasidone Monotherapy in the Treatment of Bipolar I Depression: A Randomized, Double-Blind, Placebo-Controlled Study" how the drug received FDA approval to remedy this difficult-to-treat condition.

Researchers from Sunovion Pharmaceuticals recruited approximately 500 participants with bipolar I depression in their assessment of the drug's efficacy and safety. Participants were given 20mg to 120mg per day of lurasidone or placebo for six weeks. Changes in depression were measured by the Montgomery Asberg Depression Rating Scale (MADRS), and depression severity was measured by the Clinical Global Impression scale for bipolar illness (CGI-BP).

Results showed that lurasidone reduced MADRS scores 31% more than placebo did and decreased CGI-BP scores by more than 38% compared with placebo. In addition, those given lurasidone showed improvements in anxiety symptoms and patient-reported quality of life and functional impairment. The most frequent adverse events reported by participants were nausea, headache, restlessness, and drowsiness. Discontinuation rates due to adverse events were similar among both active and placebo groups.

R.H. Belmaker, M.D., a faculty member in the Bipolar Clinic at Hadassah Medical Center in Israel, commented in an accompanying editorial that "sometimes incremental progress in psychopharmacology can gradually add up after much preclinical work, [and] many clinical trials... The discovery of a D2 blocker with a concomitant receptor profile that…avoids cardiovascular side effects and is also effective in bipolar disorder could be a serious advance of the field. Together with the large number of overlapping genetic linkages between schizophrenia and bipolar disorder, one might envision an impact on the battle over unitary psychosis theory that could even affect DSM-6."

To read more about lurasidone and its FDA approval, see the Psychiatric News article "FDA Approves Antipsychotic to Treat Bipolar Depression.” Also see Belmaker's book review of "The Bipolar Brain: Integrating Neuroimaging and Genetics" in the American Journal of Psychiatry.

(Image: Courtesy of


The content of Psychiatric News does not necessarily reflect the views of APA or the editors. Unless so stated, neither Psychiatric News nor APA guarantees, warrants, or endorses information or advertising in this newspaper. Clinical opinions are not peer reviewed and thus should be independently verified.