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

Study Identifier:
382-201-00001
ClinicalTrials.gov Identifier:
NCT05593029
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Active, Not Recruiting
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Study Details

Medical Condition
  • Depression
Study Drug
  • Drug: SEP-363856
Date
Nov 2022 - Nov 2025
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years
Requirements Information
Inclusion and Exclusion 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 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.

Protocol 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

Study Locations

Location
Status
Location
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Status
N/A
Location
Scottsdale Clinical Research
Scottsdale, Arizona, United States, 85260
Status
N/A
Location
ProScience Research Group
Culver City, California, United States, 90230
Status
N/A
Location
Wr-Pri, Llc
Encino, California, United States, 91316
Status
N/A
Location
Collaborative NeuroScience Research , LLC
Garden Grove, California, United States, 92845
Status
N/A
Location
Alliance Research
Long Beach, California, United States, 90807
Status
N/A
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All rights reserved.

July 2025 01US25EUC0279

Requirements information
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.

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