Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: April 9, 2010
Last updated: February 12, 2014
Last verified: February 2014
The study will evaluate the efficacy of agomelatine compared to placebo on the reduction of Obsessive and Compulsive symptoms after 16 weeks of treatment.

Condition Intervention Phase
Obsessive Compulsive Disorder
Drug: Agomelatine A
Drug: Placebo
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Servier:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 74
Study Start Date: May 2010
Study Completion Date: April 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Agomelatine A Drug: Agomelatine A

Agomelatine 25 mg film-coated tablet

Agomelatine 2x25mg film-coated tablet

Placebo Comparator: Placebo Drug: Placebo


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Obsessive Compulsive Disorder (OCD) according to Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR),
  • Y-BOCS total score ≥ 20,
  • duration of OCD symptoms of at least one year.

Exclusion Criteria:

  • Bipolar disorder, Schizophrenic or Psychotic Disorder
  • Severe or uncontrolled organic diseases
  • Neurological disorder
  • Women of childbearing potential who are not using effective contraception
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01108393

Department of Psychiatry Chaim Sheba Medical Center
Tel Hashomer, Israel
Sponsors and Collaborators
Principal Investigator: Joseph Zohar, Prof. Department of Psychiatry Chaim Sheba Medical Center
  More Information

Responsible Party: Servier
ClinicalTrials.gov Identifier: NCT01108393     History of Changes
Other Study ID Numbers: CL2-20098-072  2009-016713-20 
Study First Received: April 9, 2010
Last Updated: February 12, 2014
Health Authority: Italy: Direttore Generale
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Israel: Ministry of Health

Keywords provided by Servier:
Obsessive Compulsive Disorder

Additional relevant MeSH terms:
Compulsive Behavior
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Anxiety Disorders
Impulsive Behavior
Mental Disorders
Personality Disorders
S 20098
Central Nervous System Depressants
Hypnotics and Sedatives
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016