Efficacy of Agomelatine in Patients with Obsessive-compulsive Disorder

Phase 1

Active, not recruiting

• Conditions: Obsessive-compulsive disorder; MedDRA version: 14.1 Level: PT Classification code 10029898 Term: Obsessive-compulsive disorder System Organ Class: 10037175 - Psychiatric disorders; Therapeutic 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

Study Timeline

• Study Start: 2010-03-17
• Study Completion: 2013-04-25
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

- 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

Exclusion Criteria

- 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