Efficacy and safety of two doses of S 90098 (1 and 2 mg/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

INTERVENTION: Eight‐week randomised treatment period with agomelatine orodispersible 1 or 2 mg/day versus placebo followed by an extension double‐blind period for 16 weeks. CONDITION: Major depressive disorder ; Mental and Behavioural Disorders ; Recurrent depressive disorder PRIMARY OUTCOME: Hamilton Rating Scale for Depression (HAM‐D), assessed from baseline to week 24 SECONDARY OUTCOME: 1. Safety; 2. Sleep (Leeds Sleep Evaluation Questionnaire [LSEQ]); 3. Long term efficacy; 4. Pharmacokinetic; ; Outcome measures will be assessed from baseline to week 24. INCLUSION CRITERIA: 1. Between 18 (or minimum legal age) and 70 years of age 2. Out‐patients of both genders 3. Fulfilling Diagnostic and Statistical Manual of Mental Disorders ‐ Fourth Edition (DSM‐IV) criteria for major depressive disorder (MDD)