Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder

Sponsor

Institut de Recherches Internationales Servier (Other)

Overall Status

Completed

CT.gov ID

NCT01108393

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 1, 2010

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Y-BOCS total score [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

NIMH-OC score [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.
MADRS total score [16 weeks]
Montgomery and Asberg Depression rating scale (MADRS) Total score. This scale measures the severity of depressive symptoms from baseline to week 16.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.