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Efficacy and safety of 2 doses of agomelatine (10mg, 25mg) given orally in children (from 7 to less than 12 years) and adolescents (from 12 to less than 18 years) with moderate to severe Major Depressive Disorder. A 12-week, randomized, double-blind, active (fluoxetine 10 mg/day with potential adjustment to 20 mg/day) and placebo-controlled, parallel groups, international, multicentre study followed by an optional open-labelled 21-month safety extension period.

Servier Protocol Code: CL3-20098-076 Sponsor: Institut de Recherches Internationales Servier (I.R.I.S) EudraCT Number: 2015-002181-23

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Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00

Results
Interventions / Treatments
  • Major Depressive Disorder
  • AGOMELATINE
  • S020098
Other study id numbers
  • CL3-20098-076