Efficacy of agomelatine given orally on improvement of subjective sleep in patients with major depressive disorder: a randomised, double-blind, flexible-dose international multicentre study with parallel groups versus Selective Serotonin Reuptake Inhibitor (SSRI) twelve week treatment plus double-blind extension for 12 weeks

Phase 3

Completed

• Conditions: Major Depressive Disorder; Mental and Behavioural Disorders; Depressive episode

• Registration Number: ISRCTN55250367
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-12
• Study Completion: 2009-04-15
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

1. Aged between 18 to 70 years (included)
2. Male or female
3. Fulfilling Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV) criteria for major depressive disorder

Exclusion Criteria

1. Women of childbearing potential without effective contraception as well as pregnant or breastfeeding women
2. All types of depression other than major depressive disorder, all other psychiatric disorders

Study & Design

• Study Type: Interventional
• Study Design: Not specified