A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder

Phase 2 Completed 929 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.

RandomizedParallel-groupSingle-blindTreatment

Summary

Demonstrate ability of SEP-363856 to be superior to placebo as an adjunctive therapy to ADT in change from baseline in depressive symptoms (MADRS \& CGI-S) in MDD patients who had an inadequate response to prior ADT therapy.

Timeline

Start: 2022-11-09
Primary completion: 2025-11-06
Completion: 2025-11-13

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ulotaront	Small molecule	—	—

A Trial of the Safety and Efficacy of SEP-363856 in the Treatment of Adults With Major Depressive Disorder

Summary

Timeline

Drugs

Indications