Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)

Inclusion Criteria: Key Inclusion Criteria Cohort I:

• Documentation of completion of a Novartis AGO178C Double-blind Study in MDD patients.
• Male and female adults, 18 through 71 years of age, inclusive (i.e., same age range asfor Double-blind Study, but with upper age limit increased by 1-year to accommodatepatients whose age increased during the Double-blind Study).
• Female patients should continue to use effective contraception as defined indouble-blind study protocol. Inclusion Criteria: Key Inclusion criteria Cohort II:
• Male and female adults, 18 through 70 years of age, inclusive.
• 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: Key Exclusion Criteria Cohort I:

• Concomitant use of fluvoxamine.
• Any significant medical condition that emerged during Double-blind Phase of a previousstudy, which may interfere with study participation and/or study assessments asassessed by the investigator. Exclusion Criteria: Key Exclusion criteria Cohort II:
• History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eatingdisorder (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.
• Prior exposure to agomelatine.
• Female patients of childbearing potential who are not using effective contraception. Other protocol-defined inclusion/exclusion criteria may apply.