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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00182000
• Other study ID #: 2003-P-001325
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: July 10, 2012
• Start date: November 2003

Study information

• Verified date: July 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

Drug:
• seromycin
100mg tablet administered 1 hour prior to each therapy session

Behavioral:
• Behavior Therapy
10 weekly hour-long behavior therapy sessions

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Hartford Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Clinical Global Impressions Scale (CGI)		Post-treatment (week 5)	No
Secondary	Beck Depression Inventory (BDI)		Post-treatment (week 5)	No
Secondary	Beck Anxiety Inventory (BAI)		Post-treatment (week 5)	No
Secondary	Obsessional Beliefs Questionnaire (OBQ)		Post-treatment (week 5)	No
Secondary	Short-Form Health Survey (SF-36)		Post-treatment (week 5)	No
Secondary	Disability Inventory		Post-treatment (week 5)	No