Efficacy and safety of agomelatine oral administration (25 to 50 mg/day) in elderly patients suffering from Major Depressive Disorder.A 8-week, randomised, double-blind, flexible-dose, parallel groups, placebo-controlled, international, multicentre study followed by an extension double-blind treatment period of 16 weeks

• Conditions: Major Depression; MedDRA version: 12.0Level: LLTClassification code 10057840Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2009-011795-29-PT
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-28
• Last Update Posted: 15 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Out-patients of both genders - Aged older than 65 years (inclusive) - fulfilling DSM-IV criteria for Major Depressive Disorder, recurrent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

All types of depression other than Major Depressive Disorder Recurrent ; Presence of dementia or MCI ; Severe or uncontrolled organic diseases, likely to interfere with the conduct of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified