drugset / Trial / NCT01965366

Dexamethasone Plus Virtual Reality Exposure Therapy for PTSD

NCT01965366 ↗

Phase 4 Completed 27 enrolled Emory University
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2013-10
Primary completion
2017-03
Completion
2017-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator DEX Unknown 0.5 mg —