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: July 1, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Stress Disorder, Post Traumatic
Drug: D-Cycloserine
Drug: Alprazolam
Behavioral: Virtual Reality Exposure Therapy
Drug: Placebo
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychophysiological measures [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups ] [ Designated as safety issue: No ]
  • PTSD Symptom Scale Self-Report [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6 and 12 follow-ups ] [ Designated as safety issue: No ]
  • Clinical Global Impressions Scale [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups ] [ Designated as safety issue: No ]
  • Quality of Life Inventory [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups ] [ Designated as safety issue: No ]
  • State-Trait Anxiety Inventory [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups ] [ Designated as safety issue: No ]
  • Beck Depression Inventory [ Time Frame: Measured at pre- and post-treatment and at Months 3, 6, and 12 follow-ups ] [ Designated as safety issue: Yes ]

Enrollment: 156
Study Start Date: September 2006
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Participants will receive VRE therapy and D-cycloserine
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.
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.
Active Comparator: B
Participants will receive VRE therapy and alprazolam
Drug: 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.
Other Name: Xanax
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.
Placebo Comparator: C
Participants will receive VRE therapy and placebo
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356278

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Barbara O. Rothbaum, PhD, ABPP Emory University
  More Information

No publications provided by Emory University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barbara O. Rothbaum, PhD, Professor in Psychiatry and Associate Vice Chair of Clinical Research, 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
Last Updated: July 1, 2014
Health Authority: United States: Federal Government

Keywords provided by Emory University:
D-Cycloserine
Virtual Reality
Exposure Therapy
Veterans
Cognitive Behavior Therapy
Translational Research

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Alprazolam
Cycloserine
Nootropic Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites

ClinicalTrials.gov processed this record on August 27, 2014