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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Barbara O. Rothbaum, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00356278
First received: July 24, 2006
Last updated: November 17, 2014
Last verified: November 2014
Results First Received: November 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Stress Disorder, Post Traumatic
Interventions: Drug: D-Cycloserine
Drug: Alprazolam
Behavioral: Virtual Reality Exposure Therapy
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    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  
Withdrawal by Subject                 25                 15                 19  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
    VRE Therapy and D-cycloserine     VRE Therapy and Alprazolam     VRE Therapy and Placebo     Total  
Number of Participants  
[units: participants]
  53     50     53     156  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     53     50     53     156  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     4     1     3     8  
Male     49     49     50     148  
Region of Enrollment  
[units: participants]
       
United States     53     50     53     156  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinician-Administered PTSD Scale (CAPS)   [ Time Frame: Baseline ]

2.  Primary:   Clinician-Administered PTSD Scale (CAPS)   [ Time Frame: Posttreatment, 8 weeks ]

3.  Primary:   Clinician-Administered PTSD Scale (CAPS)   [ Time Frame: Month 3 ]

4.  Primary:   Clinician-Administered PTSD Scale (CAPS)   [ Time Frame: Month 6 ]

5.  Primary:   Clinician-Administered PTSD Scale (CAPS)   [ Time Frame: Month 12 ]

6.  Secondary:   PTSD Symptom Scale Self-Report   [ Time Frame: Baseline ]

7.  Secondary:   PTSD Symptom Scale Self-Report   [ Time Frame: Posttreatment, 8 weeks ]

8.  Secondary:   PTSD Symptom Scale Self-Report   [ Time Frame: Month 3 ]

9.  Secondary:   PTSD Symptom Scale Self-Report   [ Time Frame: Month 6 ]

10.  Secondary:   PTSD Symptom Scale Self-Report   [ Time Frame: Month 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: brothba@emory.edu


No publications provided by Emory University

Publications automatically indexed to this study:

Responsible Party: Barbara O. Rothbaum, PhD, Emory University
ClinicalTrials.gov Identifier: NCT00356278     History of Changes
Other Study ID Numbers: IRB00024846, DATR AD-TS, R01 MH070880
Study First Received: July 24, 2006
Results First Received: November 7, 2014
Last Updated: November 17, 2014
Health Authority: United States: Federal Government