Imaginal Exposure & D-Cycloserine (DCS) for Posttraumatic Stress Disorder (PTSD)
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|ClinicalTrials.gov Identifier: NCT00875342|
Recruitment Status : Recruiting
First Posted : April 3, 2009
Last Update Posted : February 15, 2019
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.
Patients living in areas that are not geographically proximal to the Weill-Cornell Medical Center New York City campus will receive cognitive behavioral therapy using telemedicine (videoconferencing technology).
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, 4) to determine if the BDNF SNP predicts treatment response, 5)to determine if it is feasible and acceptable to provide imaginal exposure (IE) therapy for PTSD using videoconferencing technology.
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder||Drug: DCS Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||D-cycloserine Enhanced Imaginal ExposureTherapy for Posttraumatic Stress Disorder (PTSD)|
|Actual Study Start Date :||May 2008|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
1. Cognitive behavioral treatment with exposure therapy plus D-Cycloserine (100 mg on days of therapy session (approximately 9 times)
|Placebo Comparator: Placebo||
2. Cognitive behavioral treatment with exposure therapy plus a placebo(sugar pill) (Placebo given on days of therapy session (9 times)
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875342
|Contact: Judith Cukor, Ph. D.||212 746 firstname.lastname@example.org|
|Contact: JoAnn Difede, Ph. D.||212 746 email@example.com|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10065|
|Contact: Judith Cukor, Ph. D. 212-746-4492 firstname.lastname@example.org|
|Principal Investigator:||JoAnn Difede, PhD||Weill Medical College of Cornell University|