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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 is a Phase 2 study that was terminated before completion, run by Duke University. The registered enrollment target is 15 participants.
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.
Interventions
- DRUG Brexpiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-04-25 |
| Est. Completion | 2018-04-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02934932
The ClinicalTrials.gov registry entry for NCT02934932 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Brexpiprazole is the first listed.
NCT02934932 reports 0 study locations.
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.
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