Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder

Institut de Recherches Internationales Servier74 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Obsessive Compulsive Disorder

Interventions

Agomelatine ADRUG

Agomelatine 25 mg film-coated tablet Agomelatine 2x25mg film-coated tablet

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Psychiatry Chaim Sheba Medical Center

Tel Litwinsky, Israel

Outcomes

Primary Outcomes

Y-BOCS total score

Yale-Brown Obsessive Compulsive scale (Y-BOCS) total score. This scale measures the severity of obsessive and compulsive symptoms from baseline to W16.

Time frame: 16 weeks

Secondary Outcomes

NIMH-OC score

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.

Time frame: 16 weeks

MADRS total score

Montgomery and Asberg Depression rating scale (MADRS) Total score. This scale measures the severity of depressive symptoms from baseline to week 16.

Time frame: 16 weeks

Data from ClinicalTrials.gov

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