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In double-blind trials lasting 6 weeks, FDA-approved lurasidone, whether combined with lithium or valproate or as monotherapy, has been effective for treating acute bipolar depression. A manufacturer-supported, open-label, uncontrolled study extends the earlier research by 6 months.
The 817 adult outpatient participants (mean age, 43) had bipolar I disorder and major depression but no psychosis (women, 52%; white, 66%). Roughly 40% of patients were from lurasidone monotherapy studies, and 60% were from adjunctive-therapy studies; all placebo recipients were openly switched to lurasidone. The mean lurasidone dose during the 6-month extension was 64 mg/day (range, 20–120 mg/day).
Of the 559 completers of the 6-month extension, 7% of monotherapy…