Text Size

Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Servier.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Servier
ClinicalTrials.gov Identifier:
NCT01108393
First received: April 9, 2010
Last updated: December 1, 2010
Last verified: December 2010
History of Changes
  Purpose

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:

U.S. FDA Resources

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.


Estimated Enrollment: 80
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)
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
Placebo

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108393

Contacts
Contact: Joseph Zohar, Prof. +972 3 5303300 jzohar@post.tau.ac.il

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

No publications provided

Responsible Party: Christine Marey, Institut de Recherches Internationales 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: December 1, 2010
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
Agomelatine

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders
S 20098
Hypnotics and Sedatives
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013