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Information × Registration Number 0120U104533, R & D request Title Efficacy and safety of 2 doses of agomelatine (10 mg, 25 mg) when administered orally in children (7 to less than 12 years) and adolescents (12 to less than 18 years) suffering from moderate and severe major depressive disorder. A 12-week randomized, double-blind, active (fluoxetine 10 mg / day with adjustable dose up to 20 mg / day) and placebo-controlled, in parallel groups, international, multicenter study followed by an optional extended safety period Head Skripnikov Andrii M., Доктор медичних наук Registration Date 23-10-2020 Organization Ukrainian medical stomatological Academy popup.description1 A 12-week randomized, double-blind, active (fluoxetine 10 mg / day with adjustable dose up to 20 mg / day) and placebo-controlled, in parallel groups, international, multicenter study followed by an optional extended safety period popup.nrat_date 2024-12-10 Close