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Trial record 48 of 121 for:    CYCLOSERINE OR SEROMYCIN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00182000
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : July 6, 2012
Last Update Posted : July 16, 2012
Hartford Hospital
Information provided by (Responsible Party):
Sabine Wilhelm, Massachusetts General Hospital

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).

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Drug: seromycin Behavioral: Behavior Therapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2003
Actual Primary Completion Date : January 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Yale-Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: Post-treatment (week 5) ]
    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 :
  1. Clinical Global Impressions Scale (CGI) [ Time Frame: Post-treatment (week 5) ]
  2. Beck Depression Inventory (BDI) [ Time Frame: Post-treatment (week 5) ]
  3. Beck Anxiety Inventory (BAI) [ Time Frame: Post-treatment (week 5) ]
  4. Obsessional Beliefs Questionnaire (OBQ) [ Time Frame: Post-treatment (week 5) ]
  5. Short-Form Health Survey (SF-36) [ Time Frame: Post-treatment (week 5) ]
  6. Disability Inventory [ Time Frame: Post-treatment (week 5) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00182000

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

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Responsible Party: Sabine Wilhelm, Director, Massachusetts General Hospital Identifier: NCT00182000     History of Changes
Other Study ID Numbers: 2003-P-001325
First Posted: September 16, 2005    Key Record Dates
Results First Posted: July 6, 2012
Last Update Posted: July 16, 2012
Last Verified: July 2012

Keywords provided by Sabine Wilhelm, Massachusetts General Hospital:

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