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NCT03033069 · ClinicalTrials.gov registry record · Phase 2
A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)
A Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 2
- Development phase
- 336
- Enrollment target
NCT03033069: Completed Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT03033069 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 336 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (153% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03033069, a Phase 2 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 336 participants
- Enrollment target
Study Summary
To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as monotherapy or combination therapy with Zoloft (sertraline) in adults with PTSD.
Primary Outcome
CAPS-5:clinician-rated, structured interview to assess PTSD diagnostic status, symptoms severity as defined by DSM-5. CAPS-5 Past Week version of scale was completed at Baseline and at all visits after Baseline. CAPS-5 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 item
Interventions
- DRUG Sertraline
- DRUG Brexpiprazole
- DRUG Brexpiprazole Matching Placebo
- DRUG Sertraline Matching Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 336 participants |
| Start Date | 2017-01-26 |
| Est. Completion | 2018-11-12 |
| Phase | Phase 2 |
What the finished NCT03033069 record still lists
NCT03033069 is an interventional study that assigns participants to a tested intervention. The registered 336 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (153% higher).
The record links to 0 conditions, and to 4 interventions - of which Sertraline is the first listed.
NCT03033069 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03033069 about?
NCT03033069 is a clinical study titled "A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)". To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as monotherapy or combination therapy with Zoloft (sertraline) in adults with PTSD.
What is the current status of trial NCT03033069?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 336 participants. The study started on 2017-01-26. Estimated completion is 2018-11-12.
What interventions are being tested in trial NCT03033069?
The interventions under investigation include: Sertraline (DRUG), Brexpiprazole (DRUG), Brexpiprazole Matching Placebo (DRUG), Sertraline Matching Placebo (DRUG).
Who is sponsoring clinical trial NCT03033069?
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 NCT03033069's enrollment target sits among peer trials
336 141st of 2000 higher than 1,859 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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