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

NCT ID: NCT00182000

Last Updated: 2012-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30

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.

Conditions

Obsessive-Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Seromycin

Group Type: ACTIVE_COMPARATOR

seromycin

Intervention Type: DRUG

100mg tablet administered 1 hour prior to each therapy session

Behavior Therapy

Intervention Type: BEHAVIORAL

10 weekly hour-long behavior therapy sessions

Placebo

Group Type: PLACEBO_COMPARATOR

Behavior Therapy

Intervention Type: BEHAVIORAL

10 weekly hour-long behavior therapy sessions

Interventions

seromycin

100mg tablet administered 1 hour prior to each therapy session

Intervention Type: DRUG

Behavior Therapy

10 weekly hour-long behavior therapy sessions

Intervention Type: BEHAVIORAL

Other Intervention Names

D-Cycloserine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hartford Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sabine Wilhelm

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sabine Wilhelm, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Other Identifiers

2003-P-001325

Identifier Type: -

Identifier Source: org_study_id