Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Servier
ClinicalTrials.gov Identifier:
NCT01108393
First received: April 9, 2010
Last updated: February 12, 2014
Last verified: February 2014
  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:


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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Israel
Department of Psychiatry Chaim Sheba Medical Center
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: 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
Agomelatine

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

ClinicalTrials.gov processed this record on October 23, 2014