Virtual Reality & D-cycloserine (DCS) for Posttraumatic Stress Disorder (PTSD)
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): D-Cycloserine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Cognitive behavioral treatment (CBT) including prolonged exposure enhanced by virtual reality with D-Cycloserine -100 mg on days when receiving exposure with virtual reality (approximately 10-12 times); Cognitive behavioral treatment (CBT) including prolonged exposure enhanced by virtual reality. Placebo given on days when receiving exposure with virtual reality (approximately 10-12 times).
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: World Trade Center Victims; Iraq War Veterans; PTSD