A Medication Trial Combined With Behavior Therapy for Individuals With Obsessive-compulsive Disorder
Primary Purpose
Obsessive-Compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
behavior therapy
D-Cycloserine
Sponsored by

About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring obsessive-compulsive disorder, behavior therapy, D-Cycloserine, medication, treatment trial, placebo-controlled, double-blind, randomized
Eligibility Criteria
Inclusion Criteria: Meets diagnosis for obsessive-compulsive disorder Exclusion Criteria: History of psychotic disorders History of neurological disorders History of bipolar disorders
Sites / Locations
- Anxiety Disorders Center, The Institute of Living
- Massachusetts General Hospital
Outcomes
Primary Outcome Measures
significant reduction of OCD symptoms after the completion of treatment
Secondary Outcome Measures
significant reduction of depressive symptoms after the completion of treatment
Full Information
NCT ID
NCT00126282
First Posted
August 2, 2005
Last Updated
July 27, 2009
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00126282
Brief Title
A Medication Trial Combined With Behavior Therapy for Individuals With Obsessive-compulsive Disorder
Official Title
A Randomized, Double-blind, Placebo-controlled Medication Trial With D-Cycloserine for Individuals With Obsessive-compulsive Disorder Currently Receiving Behavior Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
obsessive-compulsive disorder, behavior therapy, D-Cycloserine, medication, treatment trial, placebo-controlled, double-blind, randomized
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
behavior therapy
Intervention Type
Drug
Intervention Name(s)
D-Cycloserine
Primary Outcome Measure Information:
Title
significant reduction of OCD symptoms after the completion of treatment
Secondary Outcome Measure Information:
Title
significant reduction of depressive symptoms after the completion of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meets diagnosis for obsessive-compulsive disorder
Exclusion Criteria:
History of psychotic disorders
History of neurological disorders
History of bipolar disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Wilhelm, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Tolin, PhD
Organizational Affiliation
Hartford Institute of Living
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anxiety Disorders Center, The Institute of Living
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Medication Trial Combined With Behavior Therapy for Individuals With Obsessive-compulsive Disorder
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