Efficacy of agomelatine (25 to 50 mg/day) 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 escitalopram (10 to 20mg/day).Twelve-week treatment plus double-blind extension for 12 weeks.
- Conditions
- Major Depressive DisorderMedDRA version: 9.1Level: LLTClassification code 10057840Term: Major depression
- Registration Number
- EUCTR2006-006540-54-FR
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
Outpatients between 18 (or minimum legal age) and 70 years of age (included), male or female, fulfilling DSM-IV criteria for Major Depressive Disorder
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
All types of depression other than Major Depressive Disorder
Severe or uncontrolled organic disease, likely to interfere with the conduct of the study
Women of childbearing potential without effective contraception (oral contraceptive pill, intra-uterine contraceptive device, contraceptive implant or condom) as well as pregnant or breastfeeding women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To show that patients treated with agomelatine have an earlier improvement of subjective sleep than patients treated with escitalopram;Secondary Objective: To study the effects of agomelatine and escitalopram on depression, other sleep patterns, daytime sleepiness, quality of life and to provide additional safety and acceptability data ;Primary end point(s): Global satisfaction on sleep score expressed in terms of change from baseline
- Secondary Outcome Measures
Name Time Method