Effects of agomelatine on sleep electroencephalogram parameters compared to selective serotonin reuptake inhibitors in patients with major depressive disorder: a six-week randomised, double-blind parallel group study versus comparator, followed by a double-blind optional treatment extension period up to six months

Not Applicable

Completed

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

• Registration Number: ISRCTN44737909
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21829106

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-22
• Study Completion: 2008-09-30
• Last Update Posted: 21 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1. Aged between 18 and 60 years
2. Male or female
3. Fulfilling Diagnostic and Statistical Manual of mental disorders fourth edition (DSM-IV-TR) 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effects of agomelatine on sleep Electroencephalogram (EEG) parameters, corresponding to sleep efficiency index, compared to SSRI in patients with major depressive disorder.

Secondary Outcome Measures

Name	Time	Method
1. Other sleep parameters<br>2. Subjective sleep parameters<br>3. Daytime performance <br>4. Evaluation of depression with the Hamilton rating scale for Depression (HAM-D) scale<br>5. Safety measured with adverse events, laboratory parameters, and Electrocardiogram (ECG) parameters