Clinical trial NCT00182000: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Hartford Hospital
First posted: 2005-09-16
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: Post-treatment (week 5)
Secondary outcomes:
measure: Clinical Global Impressions Scale (CGI)
timeFrame: Post-treatment (week 5)
measure: Beck Depression Inventory (BDI)
timeFrame: Post-treatment (week 5)
measure: Beck Anxiety Inventory (BAI)
timeFrame: Post-treatment (week 5)
measure: Obsessional Beliefs Questionnaire (OBQ)
timeFrame: Post-treatment (week 5)
measure: Short-Form Health Survey (SF-36)
timeFrame: Post-treatment (week 5)
measure: Disability Inventory
timeFrame: Post-treatment (week 5)
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Sabine Wilhelm, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: