Efficacy and safety of 3 doses (0.25, 0.5 and 1mg/day) of agomelatine sublingual administration over an 8-week treatment period, in out-patients with Major Depressive Disorder. An 8-week randomised, double-blind, fixed dose, international multicentre, placebo-controlled study with parallel groups, followed by an extension double-blind treatment period of 16 weeks.
- Conditions
- Major Depressive DisorderMedDRA version: 13.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders
- Registration Number
- EUCTR2009-014045-92-EE
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 640
Outpatients, male or female, aged between 18 and 70 years (inclusive), fulfilling DSM-IV criteria for Major Depressive Disorder, single or recurrent episode
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
ASAT or ALAT or Alkaline Phosphatase (ALP) values = 3 times the upper reference range (ULN) or total bilirubin = 2 times ULN
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the antidepressant efficacy of 3 doses of S 90098 compared to placebo in out-patients suffering from Major Depressive Disorder;Secondary Objective: To provide pharmacokinetic, efficacy and safety data;Primary end point(s): HAM-D 17-item scale<br>
- Secondary Outcome Measures
Name Time Method