Clinical trial NCT01965366: Dexamethasone Plus Virtual Reality Exposure Therapy for PTSD
Official title: A Pilot Study of the Effects of Dexamethasone Administration on Virtual Reality Exposure Therapy for PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PTSD
Keywords: Dexamethasone
Virtual Reality
Military
PTSD
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2013-10-18
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Participants will be 60 males and females between ages of 21 and 65.
2. Participants must meet DSM-V criteria for PTSD due to exposure to a trauma while serving in Operation Iraqi Freedom and/or Operation Enduring Freedom-Afghanistan and Operation New Dawn.
3. Patients must be literate in English.
4. Patients must be medically healthy or medically stable such that the stress of VR and DEX are not contraindicated.
5. Participants must comprehend his or her role in the study and the risks involved in order to be entered.

Exclusion Criteria:

1. Patients with a history of mania, schizophrenia, or other psychoses;
2. Patients with prominent suicidal ideation;
3. Patients with current alcohol or drug dependence;
4. Patients unable to tolerate wearing the VR helmet;
5. Patients unwilling to take study medication;
6. Patients on psychotropic medication(s) must have been on a stable dose for at least 2 weeks prior to beginning the study and must agree not to change their current medication regimen throughout the course of the study. The concomitant use of psychotropic medications will be recorded and examined in data analyses.
7. Patients with special medical conditions such as pregnancy, renal insufficiency, or a history of significant head injury
8. Active medical disorders contributing to psychiatric sx e.g. hypo or hyperthyroidism, SLE, advanced cirrhosis, etc. (per clinical judgment of study physician)
9. Patients stabilized on potentially data-obscuring medications (glucocorticoids).

Primary outcomes:
measure: Change in The Clinician Administered PTSD Scale (CAPS)Scores
timeFrame: Baseline and immediate post treatment (up to 12 weeks from baseline)
Secondary outcomes:
measure: Change in The PTSD Symptom Scale Scores
timeFrame: Baseline and immediate post treatment (up to 12 weeks from baseline)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Barbara Rothbaum, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: