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

This study has been completed.
Sponsor:
Collaborator:
Hartford Hospital
Information provided by (Responsible Party):
Sabine Wilhelm, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00182000
First received: September 13, 2005
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

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).


Condition Intervention Phase
Obsessive-Compulsive Disorder
Drug: seromycin
Behavioral: Behavior Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Medication Trial With D-Cycloserine for Individuals With OCD Currently Receiving Behavior Therapy

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Yale-Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: Post-treatment (week 5) ] [ Designated as safety issue: No ]
    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:
  • Clinical Global Impressions Scale (CGI) [ Time Frame: Post-treatment (week 5) ] [ Designated as safety issue: No ]
  • Beck Depression Inventory (BDI) [ Time Frame: Post-treatment (week 5) ] [ Designated as safety issue: No ]
  • Beck Anxiety Inventory (BAI) [ Time Frame: Post-treatment (week 5) ] [ Designated as safety issue: No ]
  • Obsessional Beliefs Questionnaire (OBQ) [ Time Frame: Post-treatment (week 5) ] [ Designated as safety issue: No ]
  • Short-Form Health Survey (SF-36) [ Time Frame: Post-treatment (week 5) ] [ Designated as safety issue: No ]
  • Disability Inventory [ Time Frame: Post-treatment (week 5) ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: November 2003
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Seromycin Drug: seromycin
100mg tablet administered 1 hour prior to each therapy session
Other Name: D-Cycloserine
Behavioral: Behavior Therapy
10 weekly hour-long behavior therapy sessions
Placebo Comparator: Placebo Behavioral: Behavior Therapy
10 weekly hour-long behavior therapy sessions

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182000

Sponsors and Collaborators
Massachusetts General Hospital
Hartford Hospital
Investigators
Principal Investigator: Sabine Wilhelm, Ph.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Sabine Wilhelm, Director, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00182000     History of Changes
Other Study ID Numbers: 2003-P-001325
Study First Received: September 13, 2005
Results First Received: May 1, 2012
Last Updated: July 10, 2012
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
OCD

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014