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

Sponsor ID
382-201-00001
Clinicaltrials.gov ID
NCT05593029
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
382-201-00001
Trial Details
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Age
18 - 65 Years
Therapeutic Area
  • Depression
    • Sex
    Female & Male
    Trial Dates
    Nov 2022 - Nov 2025
    Healthy Volunteers
    No
    • 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
    • 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 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.

    Additional Study Details

    Phase
    Phase 2
    Study Drug
    Drug: SEP-363856
    Type
    Interventional
    Masking
    Single
    Estimated Enrollment
    929
    Additional Study Details

    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

    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.
    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.

    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
    DelSol Research
    Tucson, Arizona, United States, 85715
    Status
    N/A
    Location
    Pillar Clinical Research
    Bentonville, Arkansas, United States, 72712
    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
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