Efficacy and safety of agomelatine oral administration (25 to 50 mg/day) in elderly patients suffering from major depressive disorder: an 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

Phase 3

Completed

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

• Registration Number: ISRCTN57507360
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

1. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23842010 2. 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28383308

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-30
• Study Completion: 2011-10-31
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1. Out-patients of both genders aged more than 65 years
2. Fulfilling Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for a moderate to severe episode of a recurrent major depressive disorder

Exclusion Criteria

1. All types of depression other than major depressive disorder recurrent
2. Severe or uncontrolled organic diseases, likely to interfere with the conduct of the study
3. Current diagnosis of neurological disorders

Study & Design

• Study Type: Interventional
• Study Design: Not specified