Efficacy of agomelatine given orally on rest/activity circadian rhythms in outpatients with major depressive disorder: a randomised, double-blind international study with parallel groups versus Selective Serotonin Reuptake Inhibitor (SSRI). Six-week treatment plus optional continuation for 18 weeks.

Phase 3

Completed

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

• Registration Number: ISRCTN49376288
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20193645

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-08
• Study Completion: 2007-09-30
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Male or female
2. Out-patients
3. Aged of 18 to 60 years (inclusive)
4. Fulfilling Diagnostic and Statistical Manual of Mental Disorders - fourth edition (DSM-IV) criteria for major depressive disorder
5. Requiring an antidepressant treatment

Exclusion Criteria

1. Pregnant or breastfeeding, women of childbearing potential without effective contraception
2. All types of depression other than major depressive disorder
3. Severe or uncontrolled disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy assessed by actimetry recording

Secondary Outcome Measures

Name	Time	Method
1. Depression<br>2. Sleep