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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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Brief Summary

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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

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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

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Obsessive-Compulsive Disorder

Keywords

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OCD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

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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

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D-Cycloserine

Eligibility Criteria

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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

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Hartford Hospital

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sabine Wilhelm

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sabine Wilhelm, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Countries

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United States

Other Identifiers

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2003-P-001325

Identifier Type: -

Identifier Source: org_study_id