| Title: | 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) |
| Sponsor: | Sunovion Pharmaceuticals Inc.; Sponsor in Japan: Sumitomo in Dainippon Pharma Co. Ltd. |
| Study Phase: | 3 |
| Study Sites: | Up to 90 sites in Europe (EUR), Japan (JP), and the United States (US) |
| Indication: | Major depressive episode associated with bipolar I disorder (bipolar I depression) |
| Primary Objective: | 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). |
| Study Page: | More details and Enroll Now for Study |
