The effect of the addition of D-cycloserine to exposure sessions in the treatment of patients with obsessive-compulsive disorder. A randomized, placebo-controlled trial.

Conditions: Obsessive-Compulsive Disorder
MedDRA version: 9.1Level: LLTClassification code 10029898Term: Obsessive-compulsive disorder

Registration Number: EUCTR2007-000367-18-NL

Lead Sponsor: Meerkanten GGz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Patients with a primary DSM-IV diagnosis of OCD with an age of 18 years and older as established with the Structural Clinical Interview for axis I DSM-IV Disorders (SCID I)
-Obsessive-compulsive complaints has to be such that exposure in vivo is feasible at the outpatient department, in the clinic or the direct environment.
-Patients have to understand the rationale of exposure therapy and there has to be a readiness to participate in exposure sessions.
-If a patient uses medication, dosages have to be stable (no changes in the last 2 months and during the study period).
-Negative pregnancy test (ß-HCG in urine).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Addiction to alcohol or drugs or abuse of these compounds
-A primary diagnosis of a personality disorder
-Psychotic disorder
-Relevant somatic disorders
-Suicidal intentions
-Pregnancy or breastfeeding
-Usage of medication possibly interfering with DCS (isoniazide, protonionamide)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this pilot-study is to establish the potential efficacy of D-cycloserine (DCS), a partial NMDA agonist, in accelerating and/or augmenting the effect of exposure and response prevention (ERP) in the treatment of obsessive-compulsive disorder (OCD).;Secondary Objective: Are the effects of D-cycloserine, if established, maintained in a follow-up period of 3 months?;Primary end point(s): Acceleration of the treatment effect of ERP is taken as the primary outcome measure. <br>The differences in scores on the Y-BOCS (clinical interview) between baseline and at several time points will be taken as the main measurement

Secondary Outcome Measures