Efficacy of Agomelatine in Patients with Obsessive-compulsive Disorder
- Conditions
- Obsessive-compulsive disorderMedDRA version: 14.1 Level: PT Classification code 10029898 Term: Obsessive-compulsive disorder System Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2009-016713-20-GB
- Lead Sponsor
- Institut de recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- 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 80
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 breathfeeding 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.;<br> Secondary Objective: To evaluate agomelatine effects on:<br> - the severity of OC symptoms by using the NIMH-OC, the CGI and OC-Visual Analog Scales<br> - the severity of depressive and anxious symptoms using MADRS and HAM-A<br> - sleep using the Leeds Sleep Evaluation Questionnaire <br> - global social functioning using the Sheehan Disability Scale <br> - safety parameters<br> ;Primary end point(s): Y-BOCS total score;Timepoint(s) of evaluation of this end point: 16 weeks
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: 16 weeks;Secondary end point(s): NIMH-OC score - MADRS total score