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NCT01965366 · ClinicalTrials.gov registry record · Phase 4
Dexamethasone Plus Virtual Reality Exposure Therapy for PTSD
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 27
- Enrollment target
NCT01965366 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 27 participants.
The verdict
NCT01965366, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 27 participants
- Enrollment target
Study Summary
Evidence from preliminary studies suggests that people with PTSD have heightened fear responses and that cortisol suppression reduces this heightened fear. Research has shown the drug dexamethasone (DEX), a cortisol suppressor, reduces the startle response in civilians with PTSD. This current research proposal represents a blinded, randomized, placebo-controlled efficacy study with the goal of determining whether a drug that suppresses the stress hormone cortisol will increase the efficacy of exposure therapy. Specifically, it is proposed that a dose of DEX, given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions, will significantly enhance the rate of response and possibly the efficacy of treatment. Participants will be treated until they have experienced at least a 70% reduction in PTSD symptoms from baseline or up to 12 sessions or until they and their therapist agree treatment should be terminated, a minimum of 6 sessions to a maximum of 12 sessions. Comprehensive multi-modal outcomes will be assessed by independent assessors blind to subject condition on interviews, self-report measures, and psychophysiological measures. Participants will be assessed pre- and post-treatment and at a follow-up of 3, 6 and 12 months to assess long term effects.
Interventions
- BEHAVIORAL Virtual reality exposure therapy
- DRUG 0.5 mg DEX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2013-10 |
| Est. Completion | 2017-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01965366
The ClinicalTrials.gov registry entry for NCT01965366 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Virtual reality exposure therapy is the first listed.
NCT01965366 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01965366 about?
NCT01965366 is a clinical study titled "Dexamethasone Plus Virtual Reality Exposure Therapy for PTSD". Evidence from preliminary studies suggests that people with PTSD have heightened fear responses and that cortisol suppression reduces this heightened fear. Research has shown the drug dexamethasone (DEX), a cortisol suppressor, reduces the startle response in civilians with PTSD. This current resear...
What is the current status of trial NCT01965366?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 27 participants. The study started on 2013-10. Estimated completion is 2017-06.
What interventions are being tested in trial NCT01965366?
The interventions under investigation include: Virtual reality exposure therapy (BEHAVIORAL), 0.5 mg DEX (DRUG).
Who is sponsoring clinical trial NCT01965366?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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