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

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT05593029

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

929

Starts

2022-11-09

Expected to finish

2025-11-13

Last updated by the study team

2026-02-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode
• Subjects with a lifetime history of schizophrenia spectrum or other psychotic disorder, bipolar or related disorder, major or mild neurocognitive disorder, neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent/ follow study directions/ or otherwise safely participate in the study, borderline or antisocial personality disorder.
• Subjects with a current diagnosis of post-traumatic stress disorder, obsessive compulsive disorder, panic disorder, or eating disorder (including anorexia nervosa or bulimia).
• 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.

Where it is running

• Scottsdale Clinical Research — Scottsdale, Arizona, United States
• DelSol Research — Tucson, Arizona, United States
• Pillar Clinical Research — Bentonville, Arkansas, United States
• ProScience Research Group — Culver City, California, United States
• Wr-Pri, Llc — Encino, California, United States
• Collaborative NeuroScience Research , LLC — Garden Grove, California, United States
• Alliance Research — Long Beach, California, United States
• ATP Clinical Research, Inc. — Orange, California, United States
• Anderson Clinical Research — Redlands, California, United States
• California Mental Behavioral Health — Santee, California, United States
• Schuster Medical Research Institute SMRI — Sherman Oaks, California, United States
• Viking Clinical Research — Temecula, California, United States
• Collaborative Neuroscience Research LLC — Torrance, California, United States
• Sunwise Clinical Research with is in Lafayette, CA — Walnut Creek, California, United States
• Institute of Living Hartford Hospital — Hartford, Connecticut, United States
• Clinical Neuroscience Solutions Inc. — Jacksonville, Florida, United States
• K2 Medical Research — Maitland, Florida, United States
• Central Miami Medical Institute — Miami, Florida, United States
• Clinical Neuroscience Solutions Inc. dba CNS Healthcare — Orlando, Florida, United States
• Combined Research Orlando Phase I-IV — Orlando, Florida, United States
• K2 Medical Research — Tampa, Florida, United States
• Interventional Psychiatry of Tampa Bay — Tampa, Florida, United States
• Advanced Discovery Research LLC — Atlanta, Georgia, United States
• Renew Health Clinical Research — Snellville, Georgia, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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