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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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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Dec 2021

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At a glance

  • Drugs Agomelatine (Primary) ; Fluoxetine
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors IRIS

    • Most Recent Events

    • 28 Jun 2021 This trial has been completed in Poland, according to European Clinical Trials Database record.
    • 19 Feb 2021 This trial has been completed in Finland according to European Clinical Trials Database record.
    • 26 Sep 2020 This trial has been completed in Bulgaria, according to European Clinical Trials Database record.
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