Efficacy and safety of agomelatine oral administration (25 to 50 mg/day) in elderly patients suffering from Major Depressive Disorder.A 8-week, randomised, double-blind, flexible-dose, parallel groups, placebo-controlled, international, multicentre study followed by an extension double-blind treatment period of 16 weeks
- Conditions
- Major DepressionMedDRA version: 13.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders
- Registration Number
- EUCTR2009-011795-29-FI
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 210
Inclusion Criteria
Out-patients of both genders - Aged older than 65 years (inclusive) - fulfilling DSM-IV criteria for Major Depressive Disorder, recurrent.
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
Exclusion Criteria
All types of depression other than Major Depressive Disorder Recurrent ; Presence of dementia or MCI ; Severe or uncontrolled organic diseases, likely to interfere with the conduct of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy of agomelatine compared to placebo, in elderly out-patients suffering from Major Depressive Disorder.;Secondary Objective: To provide additional efficacy, safety and pharmacokinetic data. <br>To study the subgroup of patients aged 75 years old and older. <br>;Primary end point(s): HAM-D-17 total score
- Secondary Outcome Measures
Name Time Method