A study to determine the maintenance of efficacy of agomelatine to prevent relapse in out-patients with major depressive disorder. A 8 to 10 weeks open period treatment with agomelatine followed by 24 weeks randomised double-blind period, placebo-controlled, parallel groups and 20 weeks of optional double-blind treatment period.

Not Applicable

Completed

• Conditions: Major depressive disorder; Mental and Behavioural Disorders; Depressive disorder

• Registration Number: ISRCTN53193024
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

2009 results in: https://www.ncbi.nlm.nih.gov/pubmed/19689920 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23151774

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-16
• Study Completion: 2007-06-30
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Aged 18 to 65 years
2. Male or female
3. Out-patients
4. Requiring an antidepressant treatment

Exclusion Criteria

1. All types of depression other than major depressive disorder
2. Severe or uncontrolled organic disease
3. Pregnant or breastfeeding women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy in the prevention of depressive relapse, measured by Hamilton Depression Rating Scale (HAMD) - questionnaire

Secondary Outcome Measures

Name	Time	Method
Safety parameters, meausred by Adverse Event reporting