Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder
The study will evaluate the efficacy of agomelatine compared to placebo on the reduction of Obsessive and Compulsive symptoms after 16 weeks of treatment.
Obsessive Compulsive Disorder
Drug: Agomelatine A
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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. A Randomised, Double-blind, Placebo-controlled, Parallel Groups, International Study|
- Y-BOCS total score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Yale-Brown Obsessive Compulsive scale (Y-BOCS) total score. This scale measures the severity of obsessive and compulsive symptoms from baseline to W16.
- NIMH-OC score [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Montgomery and Asberg Depression rating scale (MADRS) Total score. This scale measures the severity of depressive symptoms from baseline to week 16.
|Study Start Date:||May 2010|
|Study Completion Date:||April 2013|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
|Experimental: Agomelatine A||
Drug: Agomelatine A
Agomelatine 25 mg film-coated tablet
Agomelatine 2x25mg film-coated tablet
|Placebo Comparator: Placebo||
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108393
|Department of Psychiatry Chaim Sheba Medical Center|
|Tel Hashomer, Israel|
|Principal Investigator:||Joseph Zohar, Prof.||Department of Psychiatry Chaim Sheba Medical Center|