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

Phase 3CompletedNCT00182000

Massachusetts General Hospital33 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obsessive-Compulsive Disorder

Interventions

seromycinDRUG

100mg tablet administered 1 hour prior to each therapy session

Behavior TherapyBEHAVIORAL

10 weekly hour-long behavior therapy sessions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Yale-Brown Obsessive Compulsive Scale (YBOCS)

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).