D-cycloserine and Virtual Reality Exposure to Treat Iraq War Veterans With PTSD
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ClinicalTrials.gov Identifier: NCT00356278 |
Recruitment Status
:
Completed
First Posted
: July 25, 2006
Results First Posted
: November 19, 2014
Last Update Posted
: January 8, 2016
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Condition or disease | Intervention/treatment | Phase |
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Stress Disorder, Post Traumatic | Drug: D-Cycloserine Drug: Alprazolam Behavioral: Virtual Reality Exposure Therapy Drug: Placebo | Phase 2 Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 156 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Cognitive Enhancer May Facilitate Behavioral Exposure Therapy for Veterans With PTSD |
Study Start Date : | September 2006 |
Actual Primary Completion Date : | June 2014 |
Actual Study Completion Date : | June 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: A
Participants will receive VRE therapy and D-cycloserine
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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.
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.
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Active Comparator: B
Participants will receive VRE therapy and alprazolam
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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.
Other Name: Xanax
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.
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Placebo Comparator: C
Participants will receive VRE therapy and placebo
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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.
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- Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Baseline ]Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
- Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Posttreatment, 8 weeks ]Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
- Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Month 3 ]Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
- Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Month 6 ]Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
- Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Month 12 ]Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
- PTSD Symptom Scale Self-Report [ Time Frame: Baseline ]PTSD Symptom Scale - Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.
- PTSD Symptom Scale Self-Report [ Time Frame: Posttreatment, 8 weeks ]PTSD Symptom Scale - Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.
- PTSD Symptom Scale Self-Report [ Time Frame: Month 3 ]PTSD Symptom Scale - Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.
- PTSD Symptom Scale Self-Report [ Time Frame: Month 6 ]PTSD Symptom Scale - Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.
- PTSD Symptom Scale Self-Report [ Time Frame: Month 12 ]PTSD Symptom Scale - Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.

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Ages Eligible for Study: | 21 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356278
United States, Georgia | |
Emory University | |
Atlanta, Georgia, United States, 30329 |
Principal Investigator: | Barbara O. Rothbaum, PhD, ABPP | Emory University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Barbara O. Rothbaum, PhD, Professor in Psychiatry and Associate Vice Chair of Clinical Research, Emory University |
ClinicalTrials.gov Identifier: | NCT00356278 History of Changes |
Other Study ID Numbers: |
IRB00024846 DATR AD-TS ( Other Identifier: Other ) R01MH070880 ( U.S. NIH Grant/Contract ) |
First Posted: | July 25, 2006 Key Record Dates |
Results First Posted: | November 19, 2014 |
Last Update Posted: | January 8, 2016 |
Last Verified: | January 2016 |
Keywords provided by Barbara O. Rothbaum, PhD, Emory University:
D-Cycloserine Virtual Reality Exposure Therapy |
Veterans Cognitive Behavior Therapy Translational Research |
Additional relevant MeSH terms:
Cycloserine Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Mental Disorders Alprazolam Anti-Infective Agents, Urinary Anti-Infective Agents Renal Agents Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents |