Trial Profile

A 12-Month Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Effectiveness of SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated With Bipolar I Disorder (Bipolar I Depression)

Status: Discontinued

Phase of Trial: Phase III

Latest Information Update: 26 Feb 2025

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At a glance

01 Dec 2023 Status changed from recruiting to discontinued.
18 Mar 2022 Planned End Date changed from 31 May 2026 to 31 May 2029.
18 Mar 2022 Planned primary completion date changed from 31 May 2026 to 31 May 2029.

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