A Phase 2/3 interventional study of D-Cycloserine and Alprazolam in Stress Disorder, Post Traumatic, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-01-08.
Sponsored by Emory University · Phase 2/3, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
Participants will receive VRE therapy and D-cycloserine
Drug: D-Cycloserine · Behavioral: Virtual Reality Exposure Therapy
Participants will receive VRE therapy and alprazolam
Drug: Alprazolam · Behavioral: Virtual Reality Exposure Therapy
Participants will receive VRE therapy and placebo
Behavioral: Virtual Reality Exposure Therapy · Drug: Placebo
D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.
Also known as: Xanax
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.
Placebo will be administered in the same manner as the active drugs.
Clinician-Administered PTSD Scale (CAPS)
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
Time frame: Baseline
Clinician-Administered PTSD Scale (CAPS)
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
Time frame: Posttreatment, 8 weeks
Clinician-Administered PTSD Scale (CAPS)
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
Time frame: Month 3
Clinician-Administered PTSD Scale (CAPS)
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
Time frame: Month 6
Clinician-Administered PTSD Scale (CAPS)
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
Time frame: Month 12
PTSD Symptom Scale Self-Report
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.
Time frame: Baseline
PTSD Symptom Scale Self-Report
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.
Time frame: Posttreatment, 8 weeks
PTSD Symptom Scale Self-Report
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.
Time frame: Month 3
PTSD Symptom Scale Self-Report
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.
Time frame: Month 6
PTSD Symptom Scale Self-Report
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.
Time frame: Month 12
Participants were self-referred or referred by professionals. Some patients were referred from both VA personnel and non-VA sources between January 2007-May 2013.
| Milestone | VRE Therapy and D-cycloserine | VRE Therapy and Alprazolam | VRE Therapy and Placebo |
|---|---|---|---|
| Started | 53 | 50 | 53 |
| Completed | 28 | 35 | 34 |
| Not completed | 25 | 15 | 19 |
| Withdrew: Withdrawal by subject | 25 | 15 | 19 |
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
| units on a scale | VRE Therapy and D-cycloserine | VRE Therapy and Alprazolam | VRE Therapy and Placebo |
|---|---|---|---|
| Clinician-Administered PTSD Scale (CAPS) | 85.3 (79.3 to 91.9) | 88 (82.3 to 93.6) | 82.6 (75.8 to 89.4) |
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.
| units on a scale | VRE Therapy and D-cycloserine | VRE Therapy and Alprazolam | VRE Therapy and Placebo |
|---|---|---|---|
| PTSD Symptom Scale Self-Report | 32.9 (29.7 to 36.2) | 32.4 (26.0 to 38.9) | 32.4 (29.1 to 35.7) |
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
| units on a scale | VRE Therapy and D-cycloserine | VRE Therapy and Alprazolam | VRE Therapy and Placebo |
|---|---|---|---|
| Clinician-Administered PTSD Scale (CAPS) | 65.9 (60.2 to 71.6) | 69.6 (63.8 to 75.4) | 63.8 (56.7 to 70.9) |
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
| units on a scale | VRE Therapy and D-cycloserine | VRE Therapy and Alprazolam | VRE Therapy and Placebo |
|---|---|---|---|
| Clinician-Administered PTSD Scale (CAPS) | 60.3 (54.4 to 66.2) | 66.8 (59.6 to 74.0) | 51.5 (43.6 to 59.5) |
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
| units on a scale | VRE Therapy and D-cycloserine | VRE Therapy and Alprazolam | VRE Therapy and Placebo |
|---|---|---|---|
| Clinician-Administered PTSD Scale (CAPS) | 56.0 (50.1 to 62.0) | 63.4 (55.4 to 71.4) | 46.9 (38.7 to 55.1) |
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
| units on a scale | VRE Therapy and D-cycloserine | VRE Therapy and Alprazolam | VRE Therapy and Placebo |
|---|---|---|---|
| Clinician-Administered PTSD Scale (CAPS) | 48.0 (41.0 to 55.0) | 57.2 (50.6 to 63.8) | 48.4 (41.0 to 55.8) |
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.
| units on a scale | VRE Therapy and D-cycloserine | VRE Therapy and Alprazolam | VRE Therapy and Placebo |
|---|---|---|---|
| PTSD Symptom Scale Self-Report | 27.1 (24.3 to 29.9) | 25.6 (22.5 to 28.7) | 24.2 (20.2 to 28.1) |
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.
| units on a scale | VRE Therapy and D-cycloserine | VRE Therapy and Alprazolam | VRE Therapy and Placebo |
|---|---|---|---|
| PTSD Symptom Scale Self-Report | 25.2 (22.0 to 28.5) | 26.1 (22.6 to 29.4) | 21.4 (17.1 to 25.6) |
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.
| units on a scale | VRE Therapy and D-cycloserine | VRE Therapy and Alprazolam | VRE Therapy and Placebo |
|---|---|---|---|
| PTSD Symptom Scale Self-Report | 24.1 (20.5 to 27.6) | 26.3 (22.5 to 30.1) | 20.0 (15.9 to 24.0) |
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.
| units on a scale | VRE Therapy and D-cycloserine | VRE Therapy and Alprazolam | VRE Therapy and Placebo |
|---|---|---|---|
| PTSD Symptom Scale Self-Report | 22.6 (19.1 to 26.1) | 24.2 (20.8 to 27.6) | 21.7 (17.9 to 25.4) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VRE Therapy and D-cycloserine | — | 0/53 (0%) | 0/53 (0%) |
| VRE Therapy and Alprazolam | — | 0/50 (0%) | 0/50 (0%) |
| VRE Therapy and Placebo | — | 0/53 (0%) | 0/53 (0%) |
| Age, Categorical(Participants) | VRE Therapy and D-cycloserine | VRE Therapy and Alprazolam | VRE Therapy and Placebo | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 53 | 50 | 53 | 156 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | VRE Therapy and D-cycloserine | VRE Therapy and Alprazolam | VRE Therapy and Placebo | Total |
|---|---|---|---|---|
| Female | 4 | 1 | 3 | 8 |
| Male | 49 | 49 | 50 | 148 |
| Region of Enrollment(participants) | VRE Therapy and D-cycloserine | VRE Therapy and Alprazolam | VRE Therapy and Placebo | Total |
|---|---|---|---|---|
| United States | 53 | 50 | 53 | 156 |
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Stress Disorders, Post-Traumatic→
Emory University