Evaluation of efficacy and clinical benefit of agomelatine (25 to 50 mg/day) over a 6-month treatment period in patients with Major Depressive Disorder.A randomised, double-blind, international multicentre study with parallel groups versus duloxetine (60 mg/day).Twenty-four weeks of treatment.
- Conditions
- Major Depressive DisorderMedDRA version: 11.0Level: LLTClassification code 10057840Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2008-004642-92-PT
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Out-patients of both genders - Aged between 18 (or minimum legal age) and 65 years (inclusive) - 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) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Women of childbearing potential without effective contraception, - Other types of depression than MDD, - Any clinically relevant abnormality detected during the physical examination, ECG or laboratory tests likely to interfere with the study conduct or evaluations.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): HAM-D;Main Objective: Long-term antidepressant efficacy of agomelatine compared to duloxetine. ;Secondary Objective: Global clinical benefit of agomelatine, effect on depressive symptoms, sleep patterns, social functioning and quality of life.<br>To provide additional safety and tolerability data on agomelatine.
- Secondary Outcome Measures
Name Time Method