NCT05593029

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

A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Flexible Doses of SEP-363856 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 929 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	SEP-363856	Tablet
OTHER	Placebo	Placebo

Timeline

• Start date: 2022-11-09
• Primary completion: 2025-11-06
• Completion: 2025-11-13
• First posted: 2022-10-25
• Last updated: 2026-02-18

Locations

77 sites across 7 countries: United States, Bulgaria, Canada, Czechia, Germany, Hungary, Poland

Regulatory

• FDA-regulated drug study