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NCT02934932
A Pilot Dose-Response Biomarker Study of Brexpiprazole Treatment in PTSD
Phase 2 trial testing Brexpiprazole in Post Traumatic Stress Disorder in 15 participants. Terminated before completion.
30 April 2018
Quick facts
| Lead sponsor | Duke University |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 25 April 2017 |
| Primary completion | 30 April 2018 |
| Estimated completion | 30 April 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Brexpiprazole (BREXPIPRAZOLE) — full drug profile →
Conditions studied
- Post Traumatic Stress Disorder — all drugs for Post Traumatic Stress Disorder →
Sponsor
Duke University
Who can join
Adults 18 to 65, any sex, with Post Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Trials testing the same drug.
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Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02934932 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Duke University
- Last refreshed: 5 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02934932.
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