A Clinical Study of an Investigational Drug for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder.
Summary
A clinical trial to study the efficacy and safety of an investigational drug in people with major depressive episodes associated with with Bipolar I disorder (bipolar I depression) Participants in the study will either receive the drug being studied or a placebo. The study will be conducted in approximately 90 sites in North America, Europe, Latin America and Japan. It will be have both male and female participants ages 18-65. Participation in the study will be approximately 10 weeks.
Timeline
- Start
- 2021-12-21
- Primary completion
- 2023-10-18
- Completion
- 2023-10-18
Outcome
Mixed primary results
Stopped (Enrollment): “Company decided not to move forward with further accrual.”
registry analysis (superiority test); Placebo vs SEP-4199 CR 200 mg; p = 0.1718; Mean Difference (Final Values) -3.94 (95% CI -9.64 to 1.75); Mixed Models Analysis NCT05169710 ↗
registry analysis (superiority test); Placebo vs SEP-4199 CR 400 mg; p = 0.028600; Mean Difference (Final Values) -6.34 (95% CI -11.99 to -0.68); Mixed Models Analysis NCT05169710 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SEP-4199 | Unknown | 200 mg | — |
| Subject | SEP-4199 | Unknown | 400 mg | — |