Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD

Sponsor ID
331-201-00071
Clinicaltrials.gov ID
NCT04124614
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
331-201-00071
Trial Details
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Age
18 - 65 Years
Therapeutic Area
  • PTSD
    • Sex
    Female & Male
    Trial Dates
    Oct 2019 - Jul 2023
    Healthy Volunteers
    No
    • Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
    • Participants who have PTSD, diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), and confirmed by the Mini International Neuropsychiatric Interview (MINI).
    • Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms for a minimum of 6 months prior to screening.
    • The index traumatic event that led to the develop of PTSD took place \> 9 years before screening.
    • The index traumatic event occurred before age 16.
    • Participants who have experienced a traumatic event within 3 months of screening.
    • Participants who are receiving disability payments because of PTSD or any other psychiatric disorder; unless the disability payments will not be impacted by potential improvements demonstrated in the trial.

    Study Summary

    This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of brexpiprazole + sertraline combination treatment in adult participants with Post-Traumatic Stress Disorder.

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: Brexpiprazole
    Type
    Interventional
    Masking
    Double
    Estimated Enrollment
    450
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • * Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
    • * Participants who have PTSD, diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), and confirmed by the Mini International Neuropsychiatric Interview (MINI).

    Exclusion Criteria

    • * The index traumatic event that led to the develop of PTSD took place \> 9 years before screening.
    • * The index traumatic event occurred before age 16.
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
    • Participants who have PTSD, diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5), and confirmed by the Mini International Neuropsychiatric Interview (MINI).
    • Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms for a minimum of 6 months prior to screening.
    Exclusion Criteria:
    • The index traumatic event that led to the develop of PTSD took place \> 9 years before screening.
    • The index traumatic event occurred before age 16.
    • Participants who have experienced a traumatic event within 3 months of screening.
    • Participants who are receiving disability payments because of PTSD or any other psychiatric disorder; unless the disability payments will not be impacted by potential improvements demonstrated in the trial.

    Study Documents

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

    Locations

    Location
    Status
    Location
    For additional information regarding sites, contact 844-687-8522
    San Diego, California, United States, 92103
    Status
    N/A

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