Effects of agomelatine (25 to 50 mg/day) on sleep EEG parameters compared to escitalopram in patients with Major Depressive Disorder.A 6-week randomised, double-blind parallel groups study versus comparator, followed by a double-blind optional treatment extension period up to 6 months.
Phase 1
- Conditions
- Major Depressive DisorderMedDRA version: 8.1Level: LLTClassification code 10057840Term: Major depression
- Registration Number
- EUCTR2006-004716-48-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
- 130
Inclusion Criteria
- Outpatients of both genders,
- Aged between 18 and 60 years,
- Fulfilling DSM-IV-TR 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) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Women of childbearing potential without effective contraception,
- Positive plasma beta hCG for women
- All types of depression other than Major Depressive Disorder,
- Contraindication to escitalopram.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate that depressed patients treated with agomelatine present a greater improvement in sleep efficiency than patients treated with escitalopram.;Secondary Objective: To show that agomelatine improves other objective sleep parameters, improves subjective sleep, restores a more physiological sleep architecture and does not impair daytime performance in depressed patients.;Primary end point(s): Sleep efficiency index<br>
- Secondary Outcome Measures
Name Time Method