A Clinical Trial to Determine the Long-term Safety and Tolerability of an Investigational Drug in People With Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression).

Summary

This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with Major Depressive Episode Associated with Bipolar I Disorder (Bipolar I Depression). Participants in the study will receive the drug being studied. This study is accepting male and female participants between 18 and 65 years old who have completed Study SEP380-301. This study will be conducted in approximately 90 study centers worldwide. The treatment duration for this study is one (1) year.

Timeline

Start

2022-03-17

Primary completion

2023-11-17

Completion

2023-11-17

Outcome

Outcome not reported

Stopped (Enrollment): “Company decided not to move forward with further accrual.”

Drugs

Indications