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

Stress Disorder, Post Traumatic Clinical Trial

Official title:

A Cognitive Enhancer May Facilitate Behavioral Exposure Therapy for Veterans With PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00356278
• Other study ID #: IRB00024846
• Secondary ID: DATR AD-TSR01MH0
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 24, 2006
• Last updated: January 6, 2016
• Start date: September 2006
• Est. completion date: June 2014

Study information

• Verified date: January 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Disorder, Post Traumatic
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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.

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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline	No
Primary	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.	Posttreatment, 8 weeks	No
Primary	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.	Month 3	No
Primary	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.	Month 6	No
Primary	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.	Month 12	No
Secondary	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.	Baseline	No
Secondary	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.	Posttreatment, 8 weeks	No
Secondary	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.	Month 3	No
Secondary	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.	Month 6	No
Secondary	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.	Month 12	No