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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 : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Servier

Brief Summary:
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 or disease Intervention/treatment Phase
Obsessive Compulsive Disorder Drug: Agomelatine A Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2010
Primary Completion Date : August 2012
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Agomelatine A Drug: Agomelatine A

Agomelatine 25 mg film-coated tablet

Agomelatine 2x25mg film-coated tablet

Placebo Comparator: Placebo Drug: Placebo
Placebo



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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

Additional Information:
Responsible Party: Servier
ClinicalTrials.gov Identifier: NCT01108393     History of Changes
Other Study ID Numbers: CL2-20098-072
2009-016713-20 ( EudraCT Number )
First Posted: April 22, 2010    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: February 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies in patients:

  • submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
Access Criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
URL: http://clinicaltrials.servier.com

Keywords provided by Servier:
Obsessive Compulsive Disorder
Agomelatine

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