Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126282
Status:
COMPLETED
Last Update Posted:
2009-07-29
First Post:
2005-08-02
Brief Title:
A Medication Trial Combined With Behavior Therapy for Individuals With Obsessive-compulsive Disorder
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Medication Trial With D-Cycloserine for Individuals With Obsessive-compulsive Disorder Currently Receiving Behavior Therapy
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None