Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder
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|ClinicalTrials.gov Identifier: NCT01108393|
Recruitment Status : Completed
First Posted : April 22, 2010
Last Update Posted : April 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obsessive Compulsive Disorder||Drug: Agomelatine A Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||April 2013|
|Experimental: Agomelatine A||
Drug: Agomelatine A
Agomelatine 25 mg film-coated tablet
Agomelatine 2x25mg film-coated tablet
|Placebo Comparator: Placebo||
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108393
|Department of Psychiatry Chaim Sheba Medical Center|
|Tel Hashomer, Israel|
|Principal Investigator:||Joseph Zohar, Prof.||Department of Psychiatry Chaim Sheba Medical Center|