Effectiveness of D-Cycloserine as an Aid to Enhance Learning for Individuals With OCD Receiving Behavior Therapy
This study has been completed.
Sponsor:
Massachusetts General Hospital
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
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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 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 Anxiety Disorders Mental 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 May 19, 2013