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

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
seromycin
Behavior Therapy
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring OCD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Seromycin

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Clinical Global Impressions Scale (CGI)
    Beck Depression Inventory (BDI)
    Beck Anxiety Inventory (BAI)
    Obsessional Beliefs Questionnaire (OBQ)
    Short-Form Health Survey (SF-36)
    Disability Inventory

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    July 10, 2012
    Sponsor
    Massachusetts General Hospital
    Collaborators
    Hartford Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00182000
    Brief Title
    Effectiveness of D-Cycloserine as an Aid to Enhance Learning for Individuals With OCD Receiving Behavior Therapy
    Official Title
    A Randomized, Double-Blind, Placebo-Controlled Medication Trial With D-Cycloserine for Individuals With OCD Currently Receiving Behavior Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2003 (undefined)
    Primary Completion Date
    January 2008 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital
    Collaborators
    Hartford Hospital

    4. Oversight

    5. Study Description

    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obsessive-Compulsive Disorder
    Keywords
    OCD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    33 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Seromycin
    Arm Type
    Active Comparator
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    seromycin
    Other Intervention Name(s)
    D-Cycloserine
    Intervention Description
    100mg tablet administered 1 hour prior to each therapy session
    Intervention Type
    Behavioral
    Intervention Name(s)
    Behavior Therapy
    Intervention Description
    10 weekly hour-long behavior therapy sessions
    Primary Outcome Measure Information:
    Title
    Yale-Brown Obsessive Compulsive Scale (YBOCS)
    Description
    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).
    Time Frame
    Post-treatment (week 5)
    Secondary Outcome Measure Information:
    Title
    Clinical Global Impressions Scale (CGI)
    Time Frame
    Post-treatment (week 5)
    Title
    Beck Depression Inventory (BDI)
    Time Frame
    Post-treatment (week 5)
    Title
    Beck Anxiety Inventory (BAI)
    Time Frame
    Post-treatment (week 5)
    Title
    Obsessional Beliefs Questionnaire (OBQ)
    Time Frame
    Post-treatment (week 5)
    Title
    Short-Form Health Survey (SF-36)
    Time Frame
    Post-treatment (week 5)
    Title
    Disability Inventory
    Time Frame
    Post-treatment (week 5)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sabine Wilhelm, Ph.D.
    Organizational Affiliation
    Massachusetts General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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