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A Medication Trial Combined With Behavior Therapy for Individuals With Obsessive-compulsive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00126282
Recruitment Status : Completed
First Posted : August 3, 2005
Last Update Posted : July 29, 2009
Information provided by:
Massachusetts General Hospital

Brief Summary:
This study examines the efficacy of the medication D-Cycloserine in the reduction of obsessions and compulsions in individuals with obsessive-compulsive disorder (OCD). All study participants will receive Exposure and Response Prevention, a common form of behavior therapy for individuals with OCD. Half (50%) of the participants will be randomly assigned to the placebo condition and the other half (50%) will be randomly assigned to receive D-Cycloserine. Because all participants will receive 10 sessions of behavior therapy, all participants are expected to improve from this treatment.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Behavioral: behavior therapy Drug: D-Cycloserine Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine

Primary Outcome Measures :
  1. significant reduction of OCD symptoms after the completion of treatment

Secondary Outcome Measures :
  1. significant reduction of depressive symptoms after the completion of treatment

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Meets diagnosis for obsessive-compulsive disorder

Exclusion Criteria:

  • History of psychotic disorders
  • History of neurological disorders
  • History of bipolar disorders

Information from the National Library of Medicine

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 identifier (NCT number): NCT00126282

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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
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Sabine Wilhelm, PhD Massachusetts General Hospital
Principal Investigator: David Tolin, PhD Hartford Institute of Living

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Responsible Party: Sabine Wilhelm, Ph.D., Massachusetts General Hospital Identifier: NCT00126282    
Other Study ID Numbers: 2003-P-0001325
First Posted: August 3, 2005    Key Record Dates
Last Update Posted: July 29, 2009
Last Verified: May 2008
Keywords provided by Massachusetts General Hospital:
obsessive-compulsive disorder
behavior therapy
treatment trial
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action