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| Sponsored by: |
Weill Medical College of Cornell University |
|---|---|
| Information provided by: | Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT00875342 |
Purpose
This study proposes to evaluate the effects of D-cycloserine (DCS) combined with cognitive-behavioral treatment with exposure therapy in a sample of patients who developed posttraumatic stress disorder (PTSD) as a consequence of various traumas (e.g., motor vehicle and accidents, burns and other injuries, combat, World Trade Center attack, etc.). 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 SNP (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: DCS Other: Placebo |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | D-cycloserine Enhanced Imaginal ExposureTherapy for Posttraumatic Stress Disorder (PTSD) |
| Estimated Enrollment: | 114 |
| Study Start Date: | May 2008 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| DCS: Experimental |
Drug: DCS
1. Cognitive behavioral treatment with exposure therapy plus D-Cycloserine (100 mg on days of therapy session (approximately 9 times)
|
| Placebo: Placebo Comparator |
Other: Placebo
2. Cognitive behavioral treatment with exposure therapy plus a placebo(sugar pill) (Placebo given on days of therapy session (9 times)
|
Following an initial assessment evaluating eligibility for the study, eligible participants will be randomly assigned to one of two treatment groups: imaginal exposure (IE) plus DCS (100mg) or IE plus placebo (sugar pill).
DCS is a broad spectrum antibiotic that has recently been implicated as a cognitive enhancer and may enhance the treatment that occurs. The participant, assessor and treating clinicians will be blinded to which pill the participant is receiving. The dose of medication will need to be taken only on the days of therapy sessions during which the exposure occurs (approximately 9 times). Both groups will be treated with a standardized cognitive-behavioral exposure therapy protocol utilizing gold-standard treatment, consisting of 12-14 weekly individual (one-on-one) sessions with a highly qualified clinical psychologist. Treatment interventions include imaginal exposure, graduated in vivo exposure, psycho-education, relaxation training, behavioral activation, and cognitive restructuring. Assessments will occur prior to treatment, following sessions 3, 6 and 10, following completion of treatment, and 6 months after the conclusion of treatment. In addition, all participants will be genotyped once for the BDNF SNP (Val66Met) using a non-invasive saliva sample.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Judith Cukor, Ph. D. | 212 746 4492 | juc2010@med.cornell.edu |
| Contact: JoAnn Difede, Ph. D. | 212 746 3079 | jdifede@med.cornell.edu |
| 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 | |
More Information
| Responsible Party: | Weill Medical College of Cornell University ( JoAnn Difede, Associate Professor of Psychology in Psychiatry ) |
| Study ID Numbers: | 0802009646 |
| Study First Received: | April 2, 2009 |
| Last Updated: | September 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00875342 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Traumatic Event Trauma Survivor Exposure Therapy PTSD DCS |
|
Antimetabolites Cycloserine Anti-Bacterial Agents Anti-Infective Agents Anxiety Disorders Mental Disorders |
Wounds and Injuries Stress Disorders, Post-Traumatic Stress Anti-Infective Agents, Urinary Antitubercular Agents Stress Disorders, Traumatic |
|
Antimetabolites Cycloserine Anti-Infective Agents Disease Molecular Mechanisms of Pharmacological Action Stress Anti-Infective Agents, Urinary Renal Agents Stress Disorders, Traumatic |
Pharmacologic Actions Antibiotics, Antitubercular Anti-Bacterial Agents Pathologic Processes Anxiety Disorders Mental Disorders Therapeutic Uses Stress Disorders, Post-Traumatic Antitubercular Agents |
