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NCT04124614 · ClinicalTrials.gov registry record · Phase 3
Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
NCT04124614: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT04124614 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 450 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04124614, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
Study 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.
Primary Outcome
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 categor
Interventions
- OTHER Placebo
- DRUG Sertraline
- DRUG Brexpiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2019-10-17 |
| Est. Completion | 2023-08-08 |
| Phase | Phase 3 |
What the finished NCT04124614 record still lists
NCT04124614 is an interventional study that assigns participants to a tested intervention. The registered 450 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 (42% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04124614 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04124614 about?
NCT04124614 is a clinical study titled "Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD". 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.
What is the current status of trial NCT04124614?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2019-10-17. Estimated completion is 2023-08-08.
What interventions are being tested in trial NCT04124614?
The interventions under investigation include: Placebo (OTHER), Sertraline (DRUG), Brexpiprazole (DRUG).
Who is sponsoring clinical trial NCT04124614?
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 NCT04124614's enrollment target sits among peer trials
450 837th of 2000 higher than 1,137 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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