A Phase 3 Trial of Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD
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|ClinicalTrials.gov Identifier: NCT04124614|
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
|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 :||577 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 3, Multicenter, Randomized, Double-blind Trial of Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder|
|Estimated Study Start Date :||October 23, 2019|
|Estimated Primary Completion Date :||November 2, 2021|
|Estimated Study Completion Date :||November 2, 2021|
Experimental: Brexpiprazole + Sertraline
3 pills: 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: 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 symptoms severity as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
- 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 or Psychosocial Functions (B-IPF) score [ Time Frame: Up to 12 weeks ]Patient-reported questionnaire consisting of 7 questions which measure PTSD-specific psychosocial function, with a lower score representing a worse outcome.
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): NCT04124614
|United States, California|
|Clinical Innovations, Inc. DBA Citrials||Recruiting|
|Bellflower, California, United States, 90706|
|Contact: Carol Anduiza 562-748-4999 firstname.lastname@example.org|
|Artemis Institute for Clinical Research||Recruiting|
|San Diego, California, United States, 92103|
|Contact: Sarah Mireles 858-278-3647 email@example.com|
|United States, New York|
|Finger Lakes Clinical Research||Recruiting|
|Rochester, New York, United States, 14618|
|Contact: Sarah Northrup 585-241-9670 firstname.lastname@example.org|
|United States, Texas|
|Grayline Research Center||Recruiting|
|Wichita Falls, Texas, United States, 76309|
|Contact: Jennifer Sharer 940-322-1131 email@example.com|