Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00126282
First received: August 2, 2005
Last updated: July 27, 2009
Last verified: May 2008

August 2, 2005
July 27, 2009
December 2003
Not Provided
significant reduction of OCD symptoms after the completion of treatment
Same as current
Complete list of historical versions of study NCT00126282 on ClinicalTrials.gov Archive Site
significant reduction of depressive symptoms after the completion of treatment
Same as current
Not Provided
Not Provided
 
A Medication Trial Combined With Behavior Therapy for Individuals With Obsessive-compulsive Disorder
A Randomized, Double-blind, Placebo-controlled Medication Trial With D-Cycloserine for Individuals With Obsessive-compulsive Disorder Currently Receiving Behavior Therapy

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obsessive-Compulsive Disorder
  • Behavioral: behavior therapy
  • Drug: D-Cycloserine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
December 2007
Not Provided

Inclusion Criteria:

  • Meets diagnosis for obsessive-compulsive disorder

Exclusion Criteria:

  • History of psychotic disorders
  • History of neurological disorders
  • History of bipolar disorders
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00126282
2003-P-0001325
Yes
Sabine Wilhelm, Ph.D., Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Sabine Wilhelm, PhD Massachusetts General Hospital
Principal Investigator: David Tolin, PhD Hartford Institute of Living
Massachusetts General Hospital
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP