Virtual Reality & D-cycloserine (DCS) for Posttraumatic Stress Disorder (PTSD) (VR-DCS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00632632
First received: February 29, 2008
Last updated: November 22, 2013
Last verified: April 2013
  Purpose

This study proposes to evaluate the effects of D-cycloserine (DCS) combined with Virtual Reality exposure therapy in a sample of patients who developed posttraumatic stress disorder (PTSD) following either the events of September 11, 2001, or military service in the war in Iraq. In addition, this study hopes to determine whether a common human genetic single nucleotide polymorphism (SNP) in a growth factor, brain derived neurotrophic factor, BDNF (Val66Met), predicts treatment response to PTSD.

Overall, this study aims 1) to determine if subjects administered DCS show a significantly larger decrease in symptoms of PTSD as compared to those administered a placebo, 2) to determine if subjects administered DCS show a decrease in PTSD symptomatology significantly earlier (as measured by weeks) than those administered a placebo, 3) to determine if differences in symptomatology are evident at a 6-month follow-up and indicate long-term differences between groups, and 4) to determine if the BDNF SNP predicts treatment response.


Condition Intervention
Posttraumatic Stress Disorder
Drug: D-Cycloserine
Other: placebo

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: Combined Exposure Therapy and D-Cycloserine vs. Placebo for Posttraumatic Stress Disorder

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • symptoms of Posttraumatic Stress Disorder-Clinician Administered PTSD Scale(CAPS) and PCL [ Time Frame: At initial assessment, during treatment, immediately following treatment, and 6 months after completion of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other measures include BDI, BSI, STAXI-2, Expectancy of Therapeutic Outcomes [ Time Frame: At initial assessment, during treatment, immediately following treatment, and 6 months after completion of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2005
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: D-Cycloserine (DCS) Drug: D-Cycloserine
CBT including prolonged exposure enhanced by virtual reality D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times)
Placebo Comparator: Placebo Other: placebo
Cognitive behavioral treatment including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (10-12 times).

Detailed Description:

Participants with 9/11-related or military service in the Iraq War-related PTSD are assigned to one of two programs, following an initial assessment. Both programs include Virtual Reality Exposure Therapy (VRET) for the treatment of PTSD as well as widely-used standard cognitive-behavioral therapy techniques. The VRET is comprised of ten ninety minute sessions which involve mental imagery as well as virtual reality presentations delivered by a special display worn over the head and eyes. The virtual reality simulations consist of either images of the World Trade Center and the events of September 11, 2001 or multiple scenarios common to military personnel assigned to Iraq. One group of participants will receive the medication cycloserine (seromycin) and one group will receive a placebo drug (like a sugar pill). Participants take a dose of medication only on the days that they come to the laboratory for the Virtual Reality Exposure (VRE) sessions, and 90 minutes prior to the VRE sessions. Some subjects in the study will receive a 100 mg dose of cycloserine, and other subjects in the study will receive the placebo (sugar pill). This will be determined randomly (as by the flip of a coin). Neither the patient nor the treating clinicians will know which pill that patients are receiving; however, this arrangement may be changed if medically necessary. Patients are briefly assessed for well-being at every session, and are reassessed following session three, session six, and session ten for changes in symptomatology. At the completion of treatment and again six months later, the principal investigator or one of her associates will reinterview participants and have them complete some questionnaires.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. English-speaking adults
  2. Between the ages of 18 and 70
  3. Exposed to the WTC Attacks (were in towers or in the immediate area) or veterans of the Iraq War
  4. Diagnosed with PTSD symptoms.

Exclusion Criteria:

  1. Presence of current organic mental disorder
  2. Schizophrenia
  3. Bipolar disorder
  4. Depression with psychotic features
  5. Current substance dependence
  6. Delusional disorder
  7. Active suicidal ideation, intent, or plan
  8. Active homicidal ideation, intent, or plan
  9. Use of pacemaker
  10. Medically unstable
  11. Pregnant or lactating
  12. A history of severe renal disease
  13. History of seizures
  14. Currently taking anticoagulants, ethionamide (Trecator-SC) or isoniazid (INH)
  15. History of allergic reaction to cycloserine.
  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: NCT00632632

Contacts
Contact: Judith Cukor, Ph.D. 212-746-4492 juc2010@med.cornell.edu
Contact: JoAnn Difede, Ph.D. 212-746-3079 jdifede@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Judith Cukor, Ph.D.    212-746-4492    juc2010@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: JoAnn Difede, PhD Weill Medical College of Cornell University
  More Information

Additional Information:
No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00632632     History of Changes
Obsolete Identifiers: NCT00161499
Other Study ID Numbers: 0411007625
Study First Received: February 29, 2008
Last Updated: November 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
World Trade Center Victims
Iraq War Veterans
PTSD

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes
Cycloserine
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antibiotics, Antitubercular
Antimetabolites
Antitubercular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014