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Trial record 96 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

D-cycloserine and Virtual Reality Exposure to Treat Iraq War Veterans With PTSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00356278
Recruitment Status : Completed
First Posted : July 25, 2006
Results First Posted : November 19, 2014
Last Update Posted : January 8, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Barbara O. Rothbaum, PhD, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Stress Disorder, Post Traumatic
Interventions Drug: D-Cycloserine
Drug: Alprazolam
Behavioral: Virtual Reality Exposure Therapy
Drug: Placebo
Enrollment 156
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title VRE Therapy and D-cycloserine VRE Therapy and Alprazolam VRE Therapy and Placebo
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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.

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.

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.

Period Title: Overall Study
Started 53 50 53
Completed 28 35 34
Not Completed 25 15 19
Reason Not Completed
Withdrawal by Subject             25             15             19
Arm/Group Title VRE Therapy and D-cycloserine VRE Therapy and Alprazolam VRE Therapy and Placebo Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 53 50 53 156
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 50 participants 53 participants 156 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
53
 100.0%
50
 100.0%
53
 100.0%
156
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 50 participants 53 participants 156 participants
Female
4
   7.5%
1
   2.0%
3
   5.7%
8
   5.1%
Male
49
  92.5%
49
  98.0%
50
  94.3%
148
  94.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 53 participants 50 participants 53 participants 156 participants
53 50 53 156
1.Primary Outcome
Title Clinician-Administered PTSD Scale (CAPS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data
Arm/Group Title VRE Therapy and D-cycloserine VRE Therapy and Alprazolam VRE Therapy and Placebo
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 53 50 53
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
85.3
(79.3 to 91.9)
88
(82.3 to 93.6)
82.6
(75.8 to 89.4)
2.Primary Outcome
Title Clinician-Administered PTSD Scale (CAPS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data
Arm/Group Title VRE Therapy and D-cycloserine VRE Therapy and Alprazolam VRE Therapy and Placebo
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 53 50 53
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
65.9
(60.2 to 71.6)
69.6
(63.8 to 75.4)
63.8
(56.7 to 70.9)
3.Primary Outcome
Title Clinician-Administered PTSD Scale (CAPS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data
Arm/Group Title VRE Therapy and D-cycloserine VRE Therapy and Alprazolam VRE Therapy and Placebo
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 53 50 53
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
60.3
(54.4 to 66.2)
66.8
(59.6 to 74.0)
51.5
(43.6 to 59.5)
4.Primary Outcome
Title Clinician-Administered PTSD Scale (CAPS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data
Arm/Group Title VRE Therapy and D-cycloserine VRE Therapy and Alprazolam VRE Therapy and Placebo
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 53 50 53
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
56.0
(50.1 to 62.0)
63.4
(55.4 to 71.4)
46.9
(38.7 to 55.1)
5.Primary Outcome
Title Clinician-Administered PTSD Scale (CAPS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data
Arm/Group Title VRE Therapy and D-cycloserine VRE Therapy and Alprazolam VRE Therapy and Placebo
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 53 50 53
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
48.0
(41.0 to 55.0)
57.2
(50.6 to 63.8)
48.4
(41.0 to 55.8)
6.Secondary Outcome
Title PTSD Symptom Scale Self-Report
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data
Arm/Group Title VRE Therapy and D-cycloserine VRE Therapy and Alprazolam VRE Therapy and Placebo
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 53 50 53
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
32.9
(29.7 to 36.2)
32.4
(26.0 to 38.9)
32.4
(29.1 to 35.7)
7.Secondary Outcome
Title PTSD Symptom Scale Self-Report
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data
Arm/Group Title VRE Therapy and D-cycloserine VRE Therapy and Alprazolam VRE Therapy and Placebo
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 53 50 53
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
27.1
(24.3 to 29.9)
25.6
(22.5 to 28.7)
24.2
(20.2 to 28.1)
8.Secondary Outcome
Title PTSD Symptom Scale Self-Report
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data
Arm/Group Title VRE Therapy and D-cycloserine VRE Therapy and Alprazolam VRE Therapy and Placebo
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 53 50 53
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
25.2
(22.0 to 28.5)
26.1
(22.6 to 29.4)
21.4
(17.1 to 25.6)
9.Secondary Outcome
Title PTSD Symptom Scale Self-Report
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data
Arm/Group Title VRE Therapy and D-cycloserine VRE Therapy and Alprazolam VRE Therapy and Placebo
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 53 50 53
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
24.1
(20.5 to 27.6)
26.3
(22.5 to 30.1)
20.0
(15.9 to 24.0)
10.Secondary Outcome
Title PTSD Symptom Scale Self-Report
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Analyses using all available information with Full Information Maximum Likelihood Estimation (FIML)to handle missing data
Arm/Group Title VRE Therapy and D-cycloserine VRE Therapy and Alprazolam VRE Therapy and Placebo
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 53 50 53
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
22.6
(19.1 to 26.1)
24.2
(20.8 to 27.6)
21.7
(17.9 to 25.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VRE Therapy and D-cycloserine VRE Therapy and Alprazolam VRE Therapy and Placebo
Hide Arm/Group Description

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.

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.

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.

All-Cause Mortality
VRE Therapy and D-cycloserine VRE Therapy and Alprazolam VRE Therapy and Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
VRE Therapy and D-cycloserine VRE Therapy and Alprazolam VRE Therapy and Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/50 (0.00%)   0/53 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
VRE Therapy and D-cycloserine VRE Therapy and Alprazolam VRE Therapy and Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/53 (0.00%)   0/50 (0.00%)   0/53 (0.00%) 
The study had a high dropout rate. 31 participants dropped out before the first treatment session. Although disheartening, the dropout rate is similar to rates in other studies with veterans and active duty personnel.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Barbara O. Rothbaum, PhD, ABPP
Organization: Emory University
Phone: 404-712-8866
Responsible Party: Barbara O. Rothbaum, PhD, 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 Submitted: July 24, 2006
First Posted: July 25, 2006
Results First Submitted: November 7, 2014
Results First Posted: November 19, 2014
Last Update Posted: January 8, 2016