This study compares two types of treatment for Post-traumatic Stress Disorder. Both treatments include Virtual Reality Exposure Therapy as well as standard cognitive-behavioral therapy techniques. One treatment also includes 100 mg of D-Cycloserine; the other treatment does not involve any medication, and includes a placebo pill only.

Condition	Intervention	Phase
Post-Traumatic Stress Disorder	Drug: D-Cycloserine	Phase II Phase III

Further Study Details: 

Primary Outcomes: Clinician-administered measures and patient self-report forms (the CAPS, and PCL) will be collected at the following intervals: initial assessment; post-treatment sessions 3, 6, and 10; outcome assessment; 6-month follow-up assessment.
Secondary Outcomes: Other measures include: BDI, BSI, STAXI, Expectancy Outcome measure.
Expected Total Enrollment:  10

Participants with 9/11-related PTSD or subsyndromal-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 simulation consists of images of the World Trade Center and the events of September 11, 2001. 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 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.

Ages Eligible for Study:  18 Years   -   70 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• English speaking only
• Between 18 and 70 years old
• Diagnosis of current PTSD and subsyndromal PTSD related to the WTC attacks

Exclusion Criteria:

• Presence of current organic mental disorder
• Schizophrenia; Bipolar Disorder
• Depression with psychotic features
• Current substance abuse
• Delusional disorder
• Active Suicidal intent or plan
• Active homicidal ideation, intent or plan
• Use of pacemaker
• Renal disease
• Taking oral anticoagulant medication
• Taking ethionamide or isoniazid
• History of Seizures
• History of hypersensitivity to cycloserine

Please refer to this study by ClinicalTrials.gov identifier  NCT00161499

JoAnn Difede, PhD      212-746-3079    jdifede@med.cornell.edu
Judith Cukor, PhD      212-746-4492    juc2010@med.cornell.edu

New York
      Weill Cornell Medical College/New York Presbyterian Hospital, New York City,  New York,  10021,  United States; Recruiting

Study chairs or principal investigators

JoAnn Difede PhD,  Principal Investigator,  Weill Cornell Medical College/New York Presbyterian Hospital   

Study ID Numbers:  DCS Study
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00161499
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13