Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder
Recruitment status was Recruiting
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|
|Estimated Study Completion Date:||October 2012|
|Estimated Primary Completion Date:||February 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||
|Contact: Joseph Zohar, Prof.||+972 3 firstname.lastname@example.org|
|Department of Psychiatry Chaim Sheba Medical Center||Recruiting|
|Tel Hashomer, Israel|
|Principal Investigator:||Joseph Zohar, Prof.||Department of Psychiatry Chaim Sheba Medical Center|