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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Medication Trial With D-Cycloserine for Individuals With OCD Currently Receiving Behavior Therapy

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Drug: seromycin
* Behavioral: Behavior Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Seromycin<br> | Drug: seromycin<br>* 100mg tablet administered 1 hour prior to each therapy session<br>* Other names: D-Cycloserine;Behavioral: Behavior Therapy<br>* 10 weekly hour-long behavior therapy sessions<br>|
| Placebo Comparator: Placebo<br> | Behavioral: Behavior Therapy<br>* 10 weekly hour-long behavior therapy sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Post-treatment (week 5) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impressions Scale (CGI) |  | Post-treatment (week 5) | 
| Beck Depression Inventory (BDI) |  | Post-treatment (week 5) | 
| Beck Anxiety Inventory (BAI) |  | Post-treatment (week 5) | 
| Obsessional Beliefs Questionnaire (OBQ) |  | Post-treatment (week 5) | 
| Short-Form Health Survey (SF-36) |  | Post-treatment (week 5) | 
| Disability Inventory |  | Post-treatment (week 5) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCD