Efficacy of agomelatine 25 mg/day (with possible increase to 50 mg/day after 8 weeks of treatment) given orally during 16 weeks in patients with Obsessive-Compulsive Disorder. A randomised, double-blind, placebo-controlled, parallel groups, international study. - ND
- Conditions
- Obsessive-compulsive disorderMedDRA version: 12.1Level: LLTClassification code 10029898Term: Obsessive-compulsive disorder
- Registration Number
- EUCTR2009-016713-20-IT
- Lead Sponsor
- INSTITUT DE RECHERCHES INTERNATIONALES SERVIER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
Out patients, male or female, aged between 18 (or legal age for majority in the country) and 65 years inclusive, - Primary diagnosis of Obsessive Compulsive Disorder according to DSM-IV-TR, - Y-BOCS total score ≥ 20, - Requiring a treatment.
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) no
F.1.3.1 Number of subjects for this age range
- Women of childbearing potential without effective contraception as well as pregnant or breastfeeding women, - Exclusive hoarders, - Early onset OCD: diagnosed by a psychiatrist and treated before the age of 12, - Severe or uncontrolled organic diseases, likely to interfere with the conduct of the study, - Mental retardation or any pervasive developmental disorder, - Hepatic impairment, - Current diagnosis of neurological disorders.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of agomelatine compared to placebo on the reduction of Obsessive and Compulsive (OC) symptoms by using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) after 16 weeks of treatment in patients fulfilling DSM-IV-TR criteria for OCD.;Secondary Objective: To evaluate agomelatine effects on: - the severity of OC symptoms by using the NIMH-OC, the CGI and OC-Visual Analog Scales - The severity of depressive and anxious symptoms using MADRS and HAM-A, - Sleep using the Leeds Sleep Evaluation Questionnaire, - Global social functioning using the Sheehan Disability Scale - Safety parameters.;Primary end point(s): Y-BOCS
- Secondary Outcome Measures
Name Time Method