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

Browse trials for

• Stress Disorders, Traumatic 1,147
• Stress Disorders, Post-Traumatic 2,239

Keywords

• PTSD

Stress Disorders, Traumatic

1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.

This study's enrollment of 591 is above the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.

Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.

Study arms

• Placebo comparator
  Placebo

  All enrolled participants received brexpiprazole-matched placebo tablets and sertraline-matched placebo tablets during the 1-week placebo run-in period.

  Other: Placebo

• Experimental
  Brexpiprazole (2 mg) + Sertraline

  Randomized participants received brexpiprazole 2 milligrams (mg), orally, once daily (QD) in combination with sertraline, 150 mg, orally, QD from Week 1 to Week 12 of the double-blind treatment (DBT) period.

  Drug: Sertraline · Drug: Brexpiprazole

• Experimental
  Brexpiprazole (3 mg) + Sertraline

  Randomized participants received brexpiprazole 3 mg, orally, QD in combination with sertraline, 150 mg, orally, QD from Week 1 to Week 12 of the DBT period.

  Drug: Brexpiprazole · Drug: Sertraline

• Experimental
  Sertraline + Placebo

  Randomized participants received sertraline 150 mg, orally, QD, in combination with sertraline matching placebo, orally, QD from Week 1 to Week 12 of the DBT period.

  Drug: Sertraline · Other: Placebo

Interventions

• DrugBrexpiprazole

  3 mg pill

  Also known as: Rexulti

• DrugSertraline

  150 mg pill

  Also known as: Zoloft

• OtherPlacebo

  Pill

• DrugBrexpiprazole

  2 mg pill

  Also known as: Rexulti

Primary outcomes

1. Change From Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Score

   CAPS-5 was a structured interview designed to assess PTSD diagnostic status and 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 categories: Category B: Intrusion symptoms (5 items); Category C: Avoidance symptoms (2 items); Category D: Cognition and mood symptoms (7 items); Category E: Arousal and 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, to yield 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 effect of treatment, trial site, visit week, and an interaction term of treatment by visit week, and included the interaction term of baseline values by visit week as a covariate.

   Time frame: Baseline (Week 1), Week 10

Secondary outcomes

1. Change in Clinical Global Impression - Severity (CGI-S) Score

   The CGI-S is a standardized, clinician-administered global rating scale that measures disease severity. To assess CGI-S, 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 to 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 effect of treatment, trial site, visit week, and an interaction term of treatment by visit week, and included the interaction term of baseline values by visit week as a covariate.

   Time frame: Baseline (Week 1), Week 10

2. Change in Brief Inventory of Psychosocial Functions (B-IPF) Score

   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. The B-IPF 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 effect of treatment, trial site, visit week, and an interaction term of treatment by visit week, and included the interaction term of baseline values by visit week as a covariate.

   Time frame: Baseline, Week 12

Baseline characteristics

Study documents

• Study protocol · Jan 4, 2023
• Statistical analysis plan · May 24, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

Supporting information: Study protocol, Csr