Phase 3
N=156
D-cycloserine and Virtual Reality Exposure to Treat Iraq War Veterans With PTSD
Stress Disorder, Post Traumatic
Bottom Line
View on ClinicalTrials.gov: NCT00356278 ↗Enrolled (actual)
156
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Clinician-Administered PTSD Scale (CAPS) — 85.3; 88; 82.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- D-Cycloserine (Drug); Alprazolam (Drug); Virtual Reality Exposure Therapy (Behavioral); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician-Administered PTSD Scale (CAPS) |
48.0; 57.2; 48.4 | — |
| PRIMARY Clinician-Administered PTSD Scale (CAPS) |
48.0; 57.2; 48.4 | — |
| PRIMARY Clinician-Administered PTSD Scale (CAPS) |
48.0; 57.2; 48.4 | — |
| PRIMARY Clinician-Administered PTSD Scale (CAPS) |
48.0; 57.2; 48.4 | — |
| PRIMARY Clinician-Administered PTSD Scale (CAPS) |
48.0; 57.2; 48.4 | — |
| SECONDARY PTSD Symptom Scale Self-Report |
22.6; 24.2; 21.7 | — |
| SECONDARY PTSD Symptom Scale Self-Report |
22.6; 24.2; 21.7 | — |
| SECONDARY PTSD Symptom Scale Self-Report |
22.6; 24.2; 21.7 | — |
| SECONDARY PTSD Symptom Scale Self-Report |
22.6; 24.2; 21.7 | — |
| SECONDARY PTSD Symptom Scale Self-Report |
22.6; 24.2; 21.7 | — |
Summary
This study will determine whether a combination of virtual reality exposure therapy and D-cycloserine will reduce post-traumatic stress disorder symptoms in Iraq war veterans.
Eligibility Criteria
Inclusion Criteria
- Meets DSM-IV criteria for PTSD due to Iraq military trauma
- Speaks English
- Healthy overall
Exclusion Criteria
- History of mania, schizophrenia, or other psychoses
- Suicidal
- Current alcohol or drug dependence
- Medication free within 2 weeks of study entry for any medication that has been taken less than daily for the past month and medicine free within 4 weeks of study entry for any anxiolytic medication that has been taken daily for the last month or more
- Pregnant
- Special medical conditions, such as kidney insufficiency, chronic diseases, or history of significant head injury
- Stabilized on potentially data obscuring medication such as glucocorticoids
Data sourced from ClinicalTrials.gov (NCT00356278). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.