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

• Status: Not yet recruiting
• Trial end date: 2025-01-21
• Target enrollment: 0
• Participant gender: All

Summary

This is 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 (MDD)

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborators: Sumitomo Pharma Co., Ltd.; Sunovion

Criteria

Inclusion Criteria:

• Male and Female subjects between 18-65 years of age, with a primary diagnosis of major depressive disorder and in a current major depressive episode

• Current major depressive episode must be at least 8 weeks and no longer than 2 years in duration

• History of an inadequate response to at least 1 and no more than 3 antidepressant treatments in the current major depressive episode

Exclusion Criteria:

• Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode

• Subjects with a current diagnosis of a cognitive, psychotic, bipolar, eating, obsessive-compulsive, panic, post-traumatic stress, or personality disorder

• Sexually active subjects, who could become pregnant, not agreeing to practice 2 sponsor approved methods of birth control or remain abstinent during the trial and for 30 days (females) or 90 days (males) after last dose of study drug.