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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Drug: Brexpiprazole
* Drug: Sertraline
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brexpiprazole + Sertraline<br>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<br>* Up to 3 mg pill<br>* Other names: Rexulti;Drug: Sertraline<br>* Up to 150 mg pill<br>* Other names: Zoloft;|
| Experimental: Sertraline<br>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<br>* Up to 150 mg pill<br>* Other names: Zoloft;|
| Other: Placebo<br>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<br>* Pill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score | 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. | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Global Impression - Severity (CGI-S) score | 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 | Up to 12 weeks | 
| Change in Brief Inventory of Psychosocial Functions (B-IPF) score | 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. | Up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD