Official Title: “A Cognitive Enhancer May Facilitate Behavioral Exposure Therapy for Veterans With PTSD”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: August 2011

Post-traumatic stress disorder (PTSD) is a type of anxiety disorder affecting people who have witnessed or experienced a traumatic event. Veterans of war are at an increased risk for developing PTSD because of their experiences with war and combat. Symptoms of PTSD often include flashbacks or nightmares, depression, anxiety or uneasiness, and feeling emotionally numb or distant toward others. Fortunately, PTSD can be treated, usually with some combination of anti-depressants, anti-anxiety medication, and therapy. Virtual reality exposure (VRE) therapy is a new type of treatment that helps people to overcome anxiety about trauma by facing situations with the use of virtual reality. D-cycloserine is a medication that has been found to enhance the effects of psychotherapy in recent studies.

This study will determine the effectiveness of VRE therapy plus D-cycloserine at reducing PTSD symptoms in Iraq war veterans.

During this study, all participants will undergo one educational session and five VRE sessions. The first session will involve gathering information, learning common reactions to trauma, and participating in a breathing relaxation approach. The following five sessions will involve reviewing memories of Iraq and watching virtual Iraq sequences. Each participant will wear a head-mounted display during which they will view scenario settings such as cities, humvee convoys, and scenes related to combat. Participants will be randomly assigned to receive D-cycloserine, alprazolam (anti-anxiety drug), or placebo one half-hour before each VRE session.

Prior to the first treatment session, participants will undergo a startle reaction procedure. This will entail hearing sudden tones that last a fraction of a second, and viewing virtual reality scenes. Three small electrodes, attached to each participant's face, will measure the number of eye blinks during the procedure. At several times throughout the study, heart rate and skin conductance will also be measured with electrodes.

Collection of saliva samples and measurement of blood pressure will also occur several times during this study. Before, during, and immediately after treatment, participants will complete questionnaires. Participants will be contacted 3, 6, and 12 months after treatment to assess symptoms and to schedule a time for an interview, additional questionnaires, and the virtual reality-based assessment.

Intervention(s) in this Clinical Trial

• Drug: D-Cycloserine
  • D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
• Drug: Alprazolam
  • Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
• Behavioral: Virtual Reality Exposure Therapy
  • VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.
• Drug: Placebo
  • Placebo will be administered in the same manner as the active drugs.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Participants will receive VRE therapy and D-cycloserine
• Active Comparator: B
  • Participants will receive VRE therapy and alprazolam
• Placebo Comparator: C
  • Participants will receive VRE therapy and placebo

Primary Measures

• Clinician-Administered PTSD Scale (CAPS)
  • Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups
    Safety Issue?: No

Secondary Measures

• Psychophysiological measures
  • Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups
    Safety Issue?: No
• PTSD Symptom Scale Self-Report
  • Time Frame: Measured at pre- and post-treatment and at Months 3, 6 and 12 follow-ups
    Safety Issue?: No
• Clinical Global Impressions Scale
  • Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups
    Safety Issue?: No
• Quality of Life Inventory
  • Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups
    Safety Issue?: No
• State-Trait Anxiety Inventory
  • Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups
    Safety Issue?: No
• Beck Depression Inventory
  • Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Mental Health (NIMH)

Overall Clinical Trial Officials and Contacts

Barbara O. Rothbaum, PhD, ABPP Principal Investigator Emory University  

Overall Contact: Cathrine Arndt Jordan, MS 404-712-8300 carndt@emory.edu

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00356278

Study ID Number: R01 MH070880

ClinicalTrials.gov Identifier: NCT00356278

Health Authority: United States: Federal Government