Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder

Sponsor ID
331-201-00289
Clinicaltrials.gov ID
NCT04830215
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
331-201-00289
Trial Details
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Age
18 - 65 Years
Therapeutic Area
  • Depression
    • Sex
    Female & Male
    Trial Dates
    Apr 2021 - May 2022
    Healthy Volunteers
    No
    • Male and female participants (outpatients) between the regional age of majority (18 or 19 years of age) to 65 years of age, inclusive, at the time of informed consent.
    • Primary diagnosis of MDD and in a current non-psychotic major depressive episode (MDE) as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, who have been outpatients for at least 4 weeks, and have an inadequate response, per investigator judgment, to 1 or 2 adequate treatments of ADTs in their current MDE, including current ADT.
    • Participants with a Patient Health Questionnaire 9-item scale (PHQ-9) ≥ 15 at the screening and baseline visits, if separate.
    • Participants currently or previously treated with brexpiprazole including participants who received brexpiprazole in any prior clinical trial.
    • Participants with a concurrent DSM-5 diagnosis of the following will be excluded:
    • Schizophrenia or schizoaffective disorder
    • Bipolar I or bipolar II disorder
    • Post-traumatic stress disorder
    • Dementia
    • Eating disorder
    • Borderline personality disorder
    • Antisocial personality disorder
    • Participants with a suicidality score of 3 based on Inventory of Depressive Symptomatology Self-Report (IDS-SR) suicidality item 18 or participants who, in the opinion of the investigator, presents a serious risk of suicide.

    Study Summary

    The clinical trial will investigate the effect of brexpiprazole on the concept of life engagement in participants with Major Depressive Disorder (MDD) with a current depressive episode.

    Additional Study Details

    Phase
    Phase 4
    Study Drug
    Drug: Brexpiprazole
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    122
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • * Male and female participants (outpatients) between the regional age of majority (18 or 19 years of age) to 65 years of age, inclusive, at the time of informed consent.
    • * Primary diagnosis of MDD and in a current non-psychotic major depressive episode (MDE) as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, who have been outpatients for at least 4 weeks, and have an inadequate response, per investigator judgment, to 1 or 2 adequate treatments of ADTs in their current MDE, including current ADT.

    Exclusion Criteria

    • * Participants currently or previously treated with brexpiprazole including participants who received brexpiprazole in any prior clinical trial.
    • * Participants with a concurrent DSM-5 diagnosis of the following will be excluded:
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Male and female participants (outpatients) between the regional age of majority (18 or 19 years of age) to 65 years of age, inclusive, at the time of informed consent.
    • Primary diagnosis of MDD and in a current non-psychotic major depressive episode (MDE) as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, who have been outpatients for at least 4 weeks, and have an inadequate response, per investigator judgment, to 1 or 2 adequate treatments of ADTs in their current MDE, including current ADT.
    • Participants with a Patient Health Questionnaire 9-item scale (PHQ-9) ≥ 15 at the screening and baseline visits, if separate.
    Exclusion Criteria:
    • Participants currently or previously treated with brexpiprazole including participants who received brexpiprazole in any prior clinical trial.
    • Participants with a concurrent DSM-5 diagnosis of the following will be excluded:
    • Schizophrenia or schizoaffective disorder
    • Bipolar I or bipolar II disorder
    • Post-traumatic stress disorder
    • Dementia
    • Eating disorder
    • Borderline personality disorder
    • Antisocial personality disorder
    • Participants with a suicidality score of 3 based on Inventory of Depressive Symptomatology Self-Report (IDS-SR) suicidality item 18 or participants who, in the opinion of the investigator, presents a serious risk of suicide.

    Study Documents

    Study Protocol
    Available Languages: English
    DOWNLOAD DOCUMENT(S)
    Statistical Analysis Plan
    Available Languages: English
    DOWNLOAD DOCUMENT(S)

    Locations

    Location
    Status
    Location
    Chatham-Kent Clinical Trials Research Centre
    Chatham, Ontario, Canada, N7L 1C1
    Status
    N/A

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