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

Inclusion Criteria: * Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria * HAM-D17 total score \> or = 22 at Screening and Baseline * CGI-Severity score \> or = 4 at Screening and Baseline * Only patients who complete the core protocol are eligible to participate in the Open-Label Extension Phase Exclusion Criteria: * History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder * Any current Axis I disorder other than major depressive disorder 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 * Female patients of childbearing potential who are not using effective contraception Other protocol-defined inclusion/exclusion criteria may apply