Effectiveness of D-Cycloserine as an Aid to Enhance Learning for Individuals With OCD Receiving Behavior Therapy

Phase 3

Completed

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Drug: seromycin; Behavioral: Behavior Therapy

• Registration Number: NCT00182000
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

This study will assess the effectiveness of Seromycin (D-cycloserine) in enhancing the positive effects of behavior therapy for people with Obsessive-Compulsive Disorder (OCD).

Detailed Description

We hope to enroll 50 subjects in a double-blind, placebo-controlled study of D-cycloserine augmentation of behavior therapy for Obsessive-Compulsive Disorder. All subjects will undergo a pre-treatment assessment, and then be randomly assigned to receive Seromycin (100 mg) or placebo one-hour before each of 10 therapy sessions. Subjects will then come in for a treatment planning session and the behavior therapy sessions delivered twice weekly for 5 weeks. Comprehensive assessments of obsessive-compulsive symptoms, mood state, and cognitions will be given at baseline, after 5 treatment sessions, after 10 sessions and 1 month and 6 months post-treatment.

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2008-01
• Results First Submitted: 2012-05-01
• Results First Submitted QC: 2012-06-05
• Status Verified: 2012-07
• Results First Posted: 2012-07-06
• Last Update Submitted: 2012-07-10
• Last Update Posted: 2012-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Structured Clinical Interview for DSM-IV (SCID) diagnosis of Obsessive Compulsive Disorder
• Score of greater than 16 on the Yale-Brown Obsessive Compulsive Scale
• Negative urinary beta-Human Chorionic Gonadotropin (hCG) test

Exclusion Criteria

• Currently taking or have taken an unstable dose of psychotropic medications within 2 months prior to enrollment
• Currently taking medications that may interfere with the study medication
• History of seizure disorder or other serious medical illnesses (e.g., cardiovascular, liver, kidney, respiratory, endocrine, neurologic, or blood-related disease)
• Current diagnosis of tuberculosis
• Other psychiatric diagnoses (e.g., alcohol dependence, bipolar disorder, psychosis, organic mental disorder, or development disorder) that are of greater concern than the obsessive-compulsive disorder diagnosis
• Currently taking medications that may lower seizure threshold (e.g., including clozapine, pethidine, and the following antibiotics in high dosage: penicillins, cephalosporins, amphotericin, and imipenem)
• Poses a serious suicidal or homicidal threat
• Currently undergoing psychotherapy
• Failure to benefit from ten or more sessions of previous Exposure and Response Prevention (ERP) treatment
• Pregnant or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Seromycin	Behavior Therapy	-
Placebo	Behavior Therapy	-
Seromycin	seromycin	-

Primary Outcome Measures

Name	Time	Method
Yale-Brown Obsessive Compulsive Scale (YBOCS)	Post-treatment (week 5)	A clinician-rated measure of obsessive-compulsive disorder severity. Each item is scored on a 0 to 4 range. Total scores are obtained by summing items 1-10 and thus range from 0 to 40 with higher scores indicating greater symptom severity. Results posted below are from the post-treatment evaluation (after 10 treatment sessions).

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impressions Scale (CGI)	Post-treatment (week 5)
Beck Depression Inventory (BDI)	Post-treatment (week 5)
Beck Anxiety Inventory (BAI)	Post-treatment (week 5)
Obsessional Beliefs Questionnaire (OBQ)	Post-treatment (week 5)
Short-Form Health Survey (SF-36)	Post-treatment (week 5)
Disability Inventory	Post-treatment (week 5)