Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder
- Conditions
- Post Traumatic Stress Disorder
- Interventions
- Registration Number
- NCT04174170
- 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 participants with post-traumatic stress disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 591
- Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
- Participants who have post-traumatic stress disorder (PTSD), diagnosed according to 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 development 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brexpiprazole + Sertraline Brexpiprazole 3 pills: Fixed dose of up to 3 milligrams (mg) /day may be administered of brexpiprazole, dose up to 150 mg/day may be administered of sertraline. Doses to be taken simultaneously. Assignment to these options may change during the treatment period. Brexpiprazole + Sertraline Sertraline 3 pills: Fixed dose of up to 3 milligrams (mg) /day may be administered of brexpiprazole, dose up to 150 mg/day may be administered of sertraline. Doses to be taken simultaneously. Assignment to these options may change during the treatment period. Sertraline 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. Sertraline Placebo 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. Placebo 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Change in Brief Inventory of Psychosocial Functions (B-IPF) score Up to 12 weeks Participant-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.
Trial Locations
- Locations (1)
For additional information regarding sites, contact 844-687-8522
🇺🇸New York, New York, United States