Efficacy and safety of 2 doses of S 90098 (1 and 2mg/day), sublingual formulation for 8 weeks 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 for 16 weeks. - FIGARO
- Conditions
- Major Depressive DisorderMedDRA version: 9.1Level: LLTClassification code 10057840Term: Major depression
- Registration Number
- EUCTR2007-003312-65-CZ
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
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
- Secondary Outcome Measures
Name Time Method