Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder

Inclusion Criteria: * Patients with diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria. * Current episode ≥4 weeks. * CGI-Severity score ≥4 at Screening and Baseline. Exclusion Criteria: * History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder. * Any other current Axis I disorder other than MDD which is the focus of treatment. * Substance or alcohol abuse in the last 30 days, dependence in the last 6 months. * Concomitant psychotropic medication, including herbal preparations and melatonin. * Psychotherapy of any type. * Prior exposure to agomelatine. * Female patients of childbearing potential who are not using effective contraception. Other protocol-defined inclusion/exclusion criteria may apply