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NCT02934932 · ClinicalTrials.gov registry record · Phase 2
A Pilot Dose-Response Biomarker Study of Brexpiprazole Treatment in PTSD
A Phase 2 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT02934932: Clinical Trial Phase 2 study, sponsored by Duke University.
NCT02934932 is a Phase 2 study that was terminated before completion, run by Duke University. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02934932, a Phase 2 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
Determine if brexpiprazole treatment will be associated with a dose-dependent reduction in resting pupil diameter as a reflection of locus coeruleus (LC) norepinephrine (NE) neuron target engagement in a group of subjects with PTSD. All subjects will be evaluated by physical examination, ECG, standard blood chemistry, hematologic labs, toxicology testing, and urinalysis. Results of these studies must demonstrate a lack of clinically significant abnormalities prior to enrollment. Subjects will need to satisfy DSM-5 criteria for PTSD and receive a CAPS-5 score of 40 or greater on testing for study enrollment. Resting pupil diameter during pupillometric evaluation after two weeks on each treatment will serve as the primary outcome measure. This will be compared in the treatment groups using mixed effects repeated measures models to evaluate if there is a significant difference in pupil size among the treatments studied. As a secondary analysis this approach will be used to evaluate whether there is treatment effect on total CAPS-5 score. Lastly, the investigators will compute correlations between pupil size and CAPS-5 scores.
Primary Outcome
Evaluate the effects of two doses of brexpiprazole on locus coeruleus (LC) norepinephrine (NE) neuron activity.
Interventions
- DRUG Brexpiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-04-25 |
| Est. Completion | 2018-04-30 |
| Phase | Phase 2 |
Why NCT02934932 stopped before completion
NCT02934932 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Brexpiprazole is the first listed.
NCT02934932 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02934932 about?
NCT02934932 is a clinical study titled "A Pilot Dose-Response Biomarker Study of Brexpiprazole Treatment in PTSD". Determine if brexpiprazole treatment will be associated with a dose-dependent reduction in resting pupil diameter as a reflection of locus coeruleus (LC) norepinephrine (NE) neuron target engagement in a group of subjects with PTSD. All subjects will be evaluated by physical examination, ECG, standa...
What is the current status of trial NCT02934932?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2017-04-25. Estimated completion is 2018-04-30.
What interventions are being tested in trial NCT02934932?
The interventions under investigation include: Brexpiprazole (DRUG).
Who is sponsoring clinical trial NCT02934932?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02934932's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 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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