Trial Outcomes & Findings for D-cycloserine and Virtual Reality Exposure to Treat Iraq War Veterans With PTSD (NCT NCT00356278)
NCT ID: NCT00356278
Last Updated: 2016-01-08
Results Overview
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
COMPLETED
PHASE2/PHASE3
156 participants
Baseline
2016-01-08
Participant Flow
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.
Participant milestones
| Measure |
VRE Therapy and D-cycloserine
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.
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.
|
VRE Therapy and Alprazolam
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.
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.
|
VRE Therapy and Placebo
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.
Placebo: Placebo will be administered in the same manner as the active drugs.
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
50
|
53
|
|
Overall Study
COMPLETED
|
28
|
35
|
34
|
|
Overall Study
NOT COMPLETED
|
25
|
15
|
19
|
Reasons for withdrawal
| Measure |
VRE Therapy and D-cycloserine
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.
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.
|
VRE Therapy and Alprazolam
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.
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.
|
VRE Therapy and Placebo
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.
Placebo: Placebo will be administered in the same manner as the active drugs.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
25
|
15
|
19
|
Baseline Characteristics
D-cycloserine and Virtual Reality Exposure to Treat Iraq War Veterans With PTSD
Baseline characteristics by cohort
| Measure |
VRE Therapy and D-cycloserine
n=53 Participants
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.
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.
|
VRE Therapy and Alprazolam
n=50 Participants
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.
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.
|
VRE Therapy and Placebo
n=53 Participants
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.
Placebo: Placebo will be administered in the same manner as the active drugs.
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
156 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=93 Participants
|
49 Participants
n=4 Participants
|
50 Participants
n=27 Participants
|
148 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=93 Participants
|
50 participants
n=4 Participants
|
53 participants
n=27 Participants
|
156 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
Outcome measures
| Measure |
VRE Therapy and D-cycloserine
n=53 Participants
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.
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.
|
VRE Therapy and Alprazolam
n=50 Participants
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.
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.
|
VRE Therapy and Placebo
n=53 Participants
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.
Placebo: Placebo will be administered in the same manner as the active drugs.
|
|---|---|---|---|
|
Clinician-Administered PTSD Scale (CAPS)
|
85.3 units on a scale
Interval 79.3 to 91.9
|
88 units on a scale
Interval 82.3 to 93.6
|
82.6 units on a scale
Interval 75.8 to 89.4
|
PRIMARY outcome
Timeframe: Posttreatment, 8 weeksPopulation: Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
Outcome measures
| Measure |
VRE Therapy and D-cycloserine
n=53 Participants
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.
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.
|
VRE Therapy and Alprazolam
n=50 Participants
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.
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.
|
VRE Therapy and Placebo
n=53 Participants
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.
Placebo: Placebo will be administered in the same manner as the active drugs.
|
|---|---|---|---|
|
Clinician-Administered PTSD Scale (CAPS)
|
65.9 units on a scale
Interval 60.2 to 71.6
|
69.6 units on a scale
Interval 63.8 to 75.4
|
63.8 units on a scale
Interval 56.7 to 70.9
|
PRIMARY outcome
Timeframe: Month 3Population: Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
Outcome measures
| Measure |
VRE Therapy and D-cycloserine
n=53 Participants
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.
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.
|
VRE Therapy and Alprazolam
n=50 Participants
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.
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.
|
VRE Therapy and Placebo
n=53 Participants
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.
Placebo: Placebo will be administered in the same manner as the active drugs.
|
|---|---|---|---|
|
Clinician-Administered PTSD Scale (CAPS)
|
60.3 units on a scale
Interval 54.4 to 66.2
|
66.8 units on a scale
Interval 59.6 to 74.0
|
51.5 units on a scale
Interval 43.6 to 59.5
|
PRIMARY outcome
Timeframe: Month 6Population: Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
Outcome measures
| Measure |
VRE Therapy and D-cycloserine
n=53 Participants
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.
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.
|
VRE Therapy and Alprazolam
n=50 Participants
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.
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.
|
VRE Therapy and Placebo
n=53 Participants
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.
Placebo: Placebo will be administered in the same manner as the active drugs.
|
|---|---|---|---|
|
Clinician-Administered PTSD Scale (CAPS)
|
56.0 units on a scale
Interval 50.1 to 62.0
|
63.4 units on a scale
Interval 55.4 to 71.4
|
46.9 units on a scale
Interval 38.7 to 55.1
|
PRIMARY outcome
Timeframe: Month 12Population: Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data
Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.
Outcome measures
| Measure |
VRE Therapy and D-cycloserine
n=53 Participants
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.
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.
|
VRE Therapy and Alprazolam
n=50 Participants
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.
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.
|
VRE Therapy and Placebo
n=53 Participants
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.
Placebo: Placebo will be administered in the same manner as the active drugs.
|
|---|---|---|---|
|
Clinician-Administered PTSD Scale (CAPS)
|
48.0 units on a scale
Interval 41.0 to 55.0
|
57.2 units on a scale
Interval 50.6 to 63.8
|
48.4 units on a scale
Interval 41.0 to 55.8
|
SECONDARY outcome
Timeframe: BaselinePopulation: Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data
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.
Outcome measures
| Measure |
VRE Therapy and D-cycloserine
n=53 Participants
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.
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.
|
VRE Therapy and Alprazolam
n=50 Participants
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.
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.
|
VRE Therapy and Placebo
n=53 Participants
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.
Placebo: Placebo will be administered in the same manner as the active drugs.
|
|---|---|---|---|
|
PTSD Symptom Scale Self-Report
|
32.9 units on a scale
Interval 29.7 to 36.2
|
32.4 units on a scale
Interval 26.0 to 38.9
|
32.4 units on a scale
Interval 29.1 to 35.7
|
SECONDARY outcome
Timeframe: Posttreatment, 8 weeksPopulation: Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data
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.
Outcome measures
| Measure |
VRE Therapy and D-cycloserine
n=53 Participants
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.
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.
|
VRE Therapy and Alprazolam
n=50 Participants
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.
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.
|
VRE Therapy and Placebo
n=53 Participants
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.
Placebo: Placebo will be administered in the same manner as the active drugs.
|
|---|---|---|---|
|
PTSD Symptom Scale Self-Report
|
27.1 units on a scale
Interval 24.3 to 29.9
|
25.6 units on a scale
Interval 22.5 to 28.7
|
24.2 units on a scale
Interval 20.2 to 28.1
|
SECONDARY outcome
Timeframe: Month 3Population: Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data
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.
Outcome measures
| Measure |
VRE Therapy and D-cycloserine
n=53 Participants
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.
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.
|
VRE Therapy and Alprazolam
n=50 Participants
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.
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.
|
VRE Therapy and Placebo
n=53 Participants
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.
Placebo: Placebo will be administered in the same manner as the active drugs.
|
|---|---|---|---|
|
PTSD Symptom Scale Self-Report
|
25.2 units on a scale
Interval 22.0 to 28.5
|
26.1 units on a scale
Interval 22.6 to 29.4
|
21.4 units on a scale
Interval 17.1 to 25.6
|
SECONDARY outcome
Timeframe: Month 6Population: Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data
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.
Outcome measures
| Measure |
VRE Therapy and D-cycloserine
n=53 Participants
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.
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.
|
VRE Therapy and Alprazolam
n=50 Participants
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.
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.
|
VRE Therapy and Placebo
n=53 Participants
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.
Placebo: Placebo will be administered in the same manner as the active drugs.
|
|---|---|---|---|
|
PTSD Symptom Scale Self-Report
|
24.1 units on a scale
Interval 20.5 to 27.6
|
26.3 units on a scale
Interval 22.5 to 30.1
|
20.0 units on a scale
Interval 15.9 to 24.0
|
SECONDARY outcome
Timeframe: Month 12Population: Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data
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.
Outcome measures
| Measure |
VRE Therapy and D-cycloserine
n=53 Participants
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.
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.
|
VRE Therapy and Alprazolam
n=50 Participants
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.
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.
|
VRE Therapy and Placebo
n=53 Participants
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.
Placebo: Placebo will be administered in the same manner as the active drugs.
|
|---|---|---|---|
|
PTSD Symptom Scale Self-Report
|
22.6 units on a scale
Interval 19.1 to 26.1
|
24.2 units on a scale
Interval 20.8 to 27.6
|
21.7 units on a scale
Interval 17.9 to 25.4
|
Adverse Events
VRE Therapy and D-cycloserine
VRE Therapy and Alprazolam
VRE Therapy and Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place