A Medication Trial Combined With Behavior Therapy for Individuals With Obsessive-compulsive Disorder
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|ClinicalTrials.gov Identifier: NCT00126282|
Recruitment Status : Completed
First Posted : August 3, 2005
Last Update Posted : July 29, 2009
|Condition or disease||Intervention/treatment||Phase|
|Obsessive-Compulsive Disorder||Behavioral: behavior therapy Drug: D-Cycloserine||Not Applicable|
The study consists of Behavior Therapy (Exposure and Response Prevention; ERP) for OCD. Specifically, it involves exposure to anxiety-provoking situations and response-prevention of any rituals. ERP has shown to be effective for many individuals with OCD.
All assessments and treatment sessions are at no cost to the patients. 50% of the patients will randomly be assigned to the D-Cycloserine (DCS) condition, and 50% of the patients will be assigned to a placebo condition. D-Cycloserine is FDA-approved for the treatment of Tuberculosis. However, recent research in other anxiety disorders has shown that D-Cycloserine plus Behavior Therapy is more effective than Behavior Therapy alone.
This treatment study has two active conditions. That is, all patients will receive Behavior Therapy and we do expect that everybody will improve from this treatment. However, it may be that those patients in the DCS condition will improve somewhat more than those in the placebo condition.
The treatment will be structured with homework and repeated assessments every 4 weeks. Assessments are extremely important as they guide the treatment and provide the study investigators necessary information about the treatment. The treatment consists of 10 sessions (twice a week) plus post-treatment and follow-up assessments at 1 and 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled Medication Trial With D-Cycloserine for Individuals With Obsessive-compulsive Disorder Currently Receiving Behavior Therapy|
|Study Start Date :||December 2003|
|Actual Study Completion Date :||December 2007|
- significant reduction of OCD symptoms after the completion of treatment
- significant reduction of depressive symptoms after the 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): NCT00126282
|United States, Connecticut|
|Anxiety Disorders Center, The Institute of Living|
|Hartford, Connecticut, United States, 06106|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Sabine Wilhelm, PhD||Massachusetts General Hospital|
|Principal Investigator:||David Tolin, PhD||Hartford Institute of Living|