Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04174170|
Recruitment Status : Recruiting
First Posted : November 22, 2019
Last Update Posted : November 15, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Post Traumatic Stress Disorder||Drug: Brexpiprazole Drug: Sertraline Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||585 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 :||October 30, 2019|
|Estimated Primary Completion Date :||July 21, 2023|
|Estimated Study Completion Date :||August 11, 2023|
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.
Up to 3 mg pill
Other Name: Rexulti
Up to 150 mg pill
Other Name: Zoloft
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.
Up to 150 mg pill
Other Name: Zoloft
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.
- Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score [ Time Frame: 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.
- Change in Clinical Global Impression - Severity (CGI-S) score [ Time Frame: 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
- Change in Brief Inventory of Psychosocial Functions (B-IPF) score [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04174170
|Contact: Otsuka Call Center||844-687-8522||OtsukaUS@druginfo.com|
|United States, New York|
|For additional information regarding sites, contact 844-687-8522||Recruiting|
|New York, New York, United States, 10010|
|Responsible Party:||Otsuka Pharmaceutical Development & Commercialization, Inc.|
|Other Study ID Numbers:||
|First Posted:||November 22, 2019 Key Record Dates|
|Last Update Posted:||November 15, 2022|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.|
Clinical Study Report (CSR)
|Time Frame:||Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.|
|Access Criteria:||Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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