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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014