A 52-week, Multi-center, Open-label Study of the Safety and Tolerability of Agomelatine Sublingual Tablets in Patients With Major Depressive Disorder (MDD)
A 52-week, Multi-center, Open-label Study of the Safety and Tolerability of Agomelatine Sublingual Tablets in Patients With Major Depressive Disorder (MDD)
The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine (AGO178) in patients with Major Depressive Disorder over a 52-week open-label phase.
Cohort I is restricted to include patients who have completed a previous Novartis agomelatine (178C) Double-blind study.
Cohort II will include de-novo patients (those who did not participate in a previous agomelatine 178C study) and will only be open for a limited time span ranging from approximately June to Sept 2010, at which point this cohort II will be closed to enrollment.
Inclusion Criteria:
Key Inclusion Criteria Cohort I:
Inclusion Criteria:
Key Inclusion criteria Cohort II:
Exclusion Criteria:
Key Exclusion Criteria Cohort I:
Exclusion Criteria:
Key Exclusion criteria Cohort II:
Other protocol-defined inclusion/exclusion criteria may apply.