Clinical Trial: Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy of Agomelatine 25mg/Day (With Possible Increase to 50mg/Day After 8 Weeks of Treatment) Given Orally During 16 Weeks in Patients With Obsessive-Compulsive Disorder

Brief Summary: The study will evaluate the efficacy of agomelatine compared to placebo on the reduction of Obsessive and Compulsive symptoms after 16 weeks of treatment.

Detailed Summary:
Sponsor: Servier

Current Primary Outcome: Y-BOCS total score [ Time Frame: 16 weeks ]

Yale-Brown Obsessive Compulsive scale (Y-BOCS) total score. This scale measures the severity of obsessive and compulsive symptoms from baseline to W16.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • NIMH-OC score [ Time Frame: 16 weeks ]
    National Institute for Mental Health- Obsessive Compulsive scale (NIMH-OC) Total Score. This scale measures the severity of obsessive and compulsive symptoms from baseline to week 16.
  • MADRS total score [ Time Frame: 16 weeks ]
    Montgomery and Asberg Depression rating scale (MADRS) Total score. This scale measures the severity of depressive symptoms from baseline to week 16.


Original Secondary Outcome: Same as current

Information By: Servier

Dates:
Date Received: April 9, 2010
Date Started: May 2010
Date Completion:
Last Updated: February 12, 2014
Last Verified: February 2014