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NCT04174170 · ClinicalTrials.gov registry record · Phase 3
Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 591
- Enrollment target
NCT04174170: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT04174170 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 591 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04174170, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 591 participants
- Enrollment target
Study 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 subjects with post-traumatic stress disorder.
Primary Outcome
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
Interventions
- OTHER Placebo
- DRUG Sertraline
- DRUG Brexpiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 591 participants |
| Start Date | 2019-10-30 |
| Est. Completion | 2023-08-15 |
| Phase | Phase 3 |
What the finished NCT04174170 record still lists
NCT04174170 is an interventional study that assigns participants to a tested intervention. The registered 591 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04174170 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04174170 about?
NCT04174170 is a clinical study titled "Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder". 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 subjects with post-traumatic stress disorder.
What is the current status of trial NCT04174170?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 591 participants. The study started on 2019-10-30. Estimated completion is 2023-08-15.
What interventions are being tested in trial NCT04174170?
The interventions under investigation include: Placebo (OTHER), Sertraline (DRUG), Brexpiprazole (DRUG).
Who is sponsoring clinical trial NCT04174170?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04174170's enrollment target sits among peer trials
591 643rd of 2000 higher than 1,358 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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