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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.
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