||A Multi-region, Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study Evaluating SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated with Bipolar I disorder (Bipolar I Depression)
||Sunovion Pharmaceuticals Inc.; Sponsor in Japan: Sumitomo in Dainippon Pharma Co. Ltd.
||Up to 90 sites in Europe (EUR), Japan (JP), and the United States (US)
||Major depressive episode associated with bipolar I disorder (bipolar I depression)
||The objective of Study SEP380-301 is to evaluate the safety, efficacy, and tolerability of SEP-4199 CR formulation given as monotherapy at fixed doses of 200 mg/day and 400 mg/day compared with placebo in the treatment of subjects with major depressive episode associated with bipolar I disorder (bipolar I depression).
||More details and Enroll Now for Study