Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD

Phase 3

Completed

• Conditions: Post Traumatic Stress Disorder
• Interventions: Drug: Brexpiprazole; Other: Placebo; Drug: Sertraline

• Registration Number: NCT04124614
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

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 participants with Post-Traumatic Stress Disorder.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-10
• Study First Posted: 2019-10-11
• Study Start: 2019-10-17
• Primary Completion: 2023-07-19
• Study Completion: 2023-08-08
• Status Verified: 2024-07
• Disposition First Submitted: 2024-07-17
• Disposition First Posted: 2024-07-18
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.
• Participants who have PTSD, diagnosed according to the 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.

Exclusion Criteria

• The index traumatic event that led to the develop 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
Sertraline	Placebo	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.
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.
Brexpiprazole + Sertraline	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. Doses to be taken simultaneously. Assignment to these options may change during the treatment period.
Sertraline	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.
Brexpiprazole + Sertraline	Brexpiprazole	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. 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 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

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 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.

Trial Locations

Locations (1)

For additional information regarding sites, contact 844-687-8522; 🇺🇸 San Diego, California, United States