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Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04174170
Collaborator
(none)
733
Enrollment
1
Location
3
Arms
50.8
Anticipated Duration (Months)
14.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of fixed-dose brexpiprazole + sertraline combination treatment in adult subjects with post-traumatic stress disorder.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
733 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Multicenter, Randomized, Double-blind Trial of Fixed-Dose Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder
Actual Study Start Date :
Oct 30, 2019
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Jan 23, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Brexpiprazole + Sertraline

3 pills: Fixed dose of up to 3 mg /day may be administered of brexpiprazole, dose up to 150 mg/day may be administered of sertraline, placebo or a combination of these. Doses to be taken simultaneously. Assignment to these options may change during the treatment period.

Drug: Brexpiprazole
Up to 3 mg pill
Other Names:
  • Rexulti

    • Drug: Sertraline
    Up to 150 mg pill
    Other Names:
  • Zoloft

    		•
    Experimental: Sertraline

    3 pills: Fixed dose up to 150 mg/ day may be administered of sertraline, placebo or a combination of these. Doses to be taken simultaneously. Assignment to these options may change during the treatment period.

    Drug: Sertraline
    Up to 150 mg pill
    Other Names:
  • Zoloft

    		•
    Other: Placebo

    3 pills: Brexpiprazole-matched placebo tablets and Sertraline-matched placebo tablets may be administered. Doses to be taken simultaneously. Assignment to these options may change during the treatment period.

    Other: Placebo
    Pill

    Outcome Measures

    Primary Outcome Measures

    1. Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score [Up to 12 weeks]

      CAPS-5 is a structured interview designed to assess PTSD diagnostic status and symptom severity as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The interview consists of 30 items, with a higher score indicating a worse outcome.

    Secondary Outcome Measures

    1. Change in Clinical Global Impression - Severity (CGI-S) score [Up to 12 weeks]

      An observer-rated scale with a total score range of 0 to 7. A higher score represents a worse outcome. Change from baseline to assess efficacy

    2. Change in Brief Inventory of Psychosocial Functions (B-IPF) score [Up to 12 weeks]

      Patient-reported questionnaire consisting of 7 questions, each scored from 0 to 6, which measure PTSD-specific psychosocial function, with a higher score representing a worse outcome.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.

    • Subjects who have PTSD, diagnosed according to 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 development of PTSD took place > 9 years before screening.

    • The index traumatic event occurred before age 16.

    • Subjects who have experienced a traumatic event within 3 months of screening.

    • Subjects 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding sites, contact 844-687-8522 New York New York United States 10010

    Sponsors and Collaborators

    • Otsuka Pharmaceutical Development & Commercialization, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Otsuka Pharmaceutical Development & Commercialization, Inc.
    ClinicalTrials.gov Identifier:
    NCT04174170
    Other Study ID Numbers:
    • 331-201-00072
    First Posted:
    Nov 22, 2019
    Last Update Posted:
    Jul 19, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.
    PTSD
    Additional relevant MeSH terms:
    Stress Disorders, Traumatic
    Stress Disorders, Post-Traumatic
    Sertraline
    Brexpiprazole

    Study Results

    No Results Posted as of Jul 19, 2022