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

Phase 2

Active, not recruiting

• Conditions: Major Depressive Disorder
• Interventions: Drug: SEP-363856; Other: Placebo

• Registration Number: NCT05593029
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief 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 respons

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-20
• Study First Posted: 2022-10-25
• Study Start: 2022-11-09
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-16
• Last Update Posted: 2025-09-17
• Primary Completion: 2025-11-14
• Study Completion: 2025-11-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 900

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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SEP-363856 & ADT (Antidepressant Therapy)	SEP-363856	-
Placebo & ADT (Antidepressant Therapy)	Placebo	-

Primary Outcome Measures

Name	Time	Method
Montgomery Åsberg Depression Rating Scale (MADRS)	From baseline to week 14	Change from the baseline to the Montgomery Åsberg Depression Rating Scale (MADRS) total score.; The Montgomery Åsberg Depression Rating Scale consists of 10 items, each rated from 0 to 6 (for a total score of 0 to 60). A higher score represents a higher severity of the level of depression.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression - Severity of Illness (CGI-S)	From baseline to week 14	Change from baseline in the Clinical Global Impression - Severity of Illness (CGI-S).; Clinical Global Impression - Severity of Illness will be measured on a scale from 1-7 where a higher score represents a higher severity of disease.

Trial Locations

Locations (74)

DelSol Research; 🇺🇸 Tucson, Arizona, United States

ClinExpert Kft.; 🇭🇺 Budapest, Hungary

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Scottsdale Clinical Research; 🇺🇸 Scottsdale, Arizona, 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

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