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

Phase 3

Completed

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

• 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
• Disposition First Submitted: 2024-07-17
• Status Verified: 2025-05
• Results First Submitted: 2025-05-08
• Results First Submitted QC: 2025-05-28
• Last Update Submitted: 2025-05-28
• Results First Posted: 2025-06-13
• Disposition First Posted: 2025-06-13
• Last Update Posted: 2025-06-13

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	Sertraline	Randomized participants received sertraline, 150 mg, orally, QD along with sertraline matching placebo, orally, QD from Week 1 to Week 12 of the DBT period.
Sertraline + Placebo	Placebo	Randomized participants received sertraline, 150 mg, orally, QD along with sertraline matching placebo, orally, QD from Week 1 to Week 12 of the DBT period.
Placebo	Placebo	All enrolled participants received brexpiprazole-matched placebo tablets and sertraline-matched placebo tablets during the 1-week placebo run-in period.
Brexpiprazole + Sertraline	Brexpiprazole	Randomized participants received brexpiprazole as a flexible dose 2 milligrams (mg) to 3 mg, orally, once daily (QD) along with sertraline, at a fixed dose of 150 mg, orally, QD from Week 1 to Week 12 of the double-blind treatment (DBT) period.
Brexpiprazole + Sertraline	Sertraline	Randomized participants received brexpiprazole as a flexible dose 2 milligrams (mg) to 3 mg, orally, once daily (QD) along with sertraline, at a fixed dose of 150 mg, orally, QD from Week 1 to Week 12 of the double-blind treatment (DBT) period.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Score	Baseline (Week 1), Week 10	CAPS-5 is a structured interview designed to assess PTSD diagnostic status \& symptoms severity as defined by DSM-5. CAPS-5 total score was calculated by summing severity scores for 20 DSM-5 PTSD symptoms (items 1-20) from following categories: Category B: Intrusion symptoms (5 items); Category C: Avoidance symptoms (2 items); Category D: Cognition \& mood symptoms (7 items); Category E: Arousal \& reactivity symptoms (6 items). CAPS-5 total score was imputed by adding all subscores from categories B, C, D, E. Each symptom was scored 0= Absent to 4= Extreme/incapacitating, yielding a score range of 0-80. Higher scores indicate worse outcome. Least squares (LS) mean was determined by Mixed-effect model repeated measures (MMRM) method with fixed class effect terms for treatment, trial site, visit, previous treatment intervention for PTSD (Yes/No), \& an interaction term of treatment by visit, \& include the interaction term of baseline values of CAPS-5 total score by visit as a covariate.

Secondary Outcome Measures

Name	Time	Method
Change in Clinical Global Impression - Severity (CGI-S) Score	Baseline (Week 1), Week 10	The CGI-S is a standardized, clinician-administered global rating scale that measures disease severity. To assess it, the rater or investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" Response choices include: 0 = not assessed; 1 = normal, not ill at all; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants. The score 0 (not assessed) was be set to missing. The CGI-S is therefore a 7-point scale from 1 through 7. A higher score on the CGI-S represents a higher severity of disease. LS mean was determined by MMRM method with fixed class effect terms for treatment, trial site, visit, previous treatment intervention for PTSD (Yes/No), \& an interaction term of treatment by visit, \& include the interaction term of baseline values of CAPS-5 total score by visit as a covariate.
Change in Brief Inventory or Psychosocial Functions (B-IPF) Score	Baseline (Day 1), Week 12	The B-IPF is a short patient-reported questionnaire consisting of 7 questions which measure PTSD-specific psychosocial function on a 7-point Likert scale (0 = not at all to 6 = very much, and a not applicable option) with a recall period of 30 days. It measures the concepts of romantic relationships, parenting, family, friendships and socializing, work, education, and self-care. Total score ranges from 0-100 and is calculated by summing the completed scale items, dividing by the maximum possible score of all items and multiplying by 100. Higher scores indicate greater impairment. LS mean was determined by MMRM method with fixed class effect terms for treatment, trial site, visit, previous treatment intervention for PTSD (Yes/No), \& an interaction term of treatment by visit, \& include the interaction term of baseline values of CAPS-5 total score by visit as a covariate.

Trial Locations

Locations (1)

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