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 toDSM-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 theOpen-Label Extension Phase

Exclusion Criteria:

• History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eatingdisorder, or obsessive compulsive disorder
• Any current Axis I disorder other than major depressive disorder which is the focus oftreatment
• 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