Skip to main content
OpenTrials
Completed

NCT Number: NCT01108393

Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder

The study will evaluate the efficacy of agomelatine compared to placebo on the reduction of Obsessive and Compulsive symptoms after 16 weeks of treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obsessive Compulsive Disorder Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Psychiatry Chaim Sheba Medical Center

Tel Litwinsky, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Agomelatine A

Drug

Agomelatine 25 mg film-coated tablet

Agomelatine 2x25mg film-coated tablet

Placebo

Drug

Placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Institut de Recherches Internationales Servier

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Apr 22, 2010
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.