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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.


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Study Phase

Phase 3

Therapeutic Area

Neuropsychiatric Diseases

Active substance/
Medical device

S020098, AGOMELATINE

SponsorInstitut de Recherches Internationales Servier (I.R.I.S)
Active Substance CodeS020098
Protocol CodeCL3-20098-076
EudraCT Code2015-002181-23


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