Efficacy of Agomelatine in Patients With Obsessive-Compulsive Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Obsessive Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Agomelatine A

Group Type EXPERIMENTAL

Agomelatine A

Intervention Type DRUG

Agomelatine 25 mg film-coated tablet

Agomelatine 2x25mg film-coated tablet

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Agomelatine A

Agomelatine 25 mg film-coated tablet

Agomelatine 2x25mg film-coated tablet

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No