Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD
Study Details
Study Description
Brief Summary
This will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of brexpiprazole + sertraline combination treatment in adult subjects with Post-Traumatic Stress Disorder.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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. |
Drug: Brexpiprazole
Up to 3 mg pill
Other Names:
Drug: Sertraline
Up to 150 mg pill
Other Names:
|
Experimental: Sertraline 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. |
Drug: Sertraline
Up to 150 mg pill
Other Names:
Other: Placebo
Pill
|
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
- 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 statusand symptoms 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
- 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 or 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
Inclusion Criteria:
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Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
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Subjects who have PTSD, diagnosed according to DSM-5, and confirmed by the Mini International Neuropsychiatric Interview (MINI).
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Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms for a minimum of 6 months prior to screening.
Exclusion Criteria:
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The index traumatic event that led to the develop of PTSD took place > 9 years before screening.
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The index traumatic event occurred before age 16.
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Subjects who have experienced a traumatic event within 3 months of screening.
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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 | |
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1 | For additional information regarding sites, contact 844-687-8522 | San Diego | California | United States | 92103 |
Sponsors and Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 331-201-00071