Efficacy and safety of three dose regimens of agomelatine versus placebo given once a day for 6 weeks in out-patients suffering from moderate to severe major depressive disorder

Phase 3

Completed

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

• Registration Number: ISRCTN10845256
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26708320

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-18
• Study Completion: 2012-04-07
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

1. Out-patients of both genders aged between 18 (or legal age) and 65 years of age
2. Fulfilling Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria for major depressive disorder (MDD) of moderate or severe intensity

Exclusion Criteria

1. Women of childbearing potential without effective contraception
2. Other types of depression than MDD
3. Severe or uncontrolled organic diseases, likely to interfere with the conduct of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified