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Efficacy and safety of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally for 8 weeks in out-patients with severe Major Depressive Disorder. A randomised double-blind, parallel groups, international study versus fluoxetine (20 mg/day with potential adjustment to 40 mg) with a double-blind extension period of 16 weeks.

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Trial Profile

Efficacy and safety of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally for 8 weeks in out-patients with severe Major Depressive Disorder. A randomised double-blind, parallel groups, international study versus fluoxetine (20 mg/day with potential adjustment to 40 mg) with a double-blind extension period of 16 weeks.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Sep 2021

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At a glance

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

    • Most Recent Events

    • 12 Sep 2009 Primary endpoint 'Hamilton Depression Rating Scale' has been met, according to results presented at the 22nd Annual Congress of the European College of Neuropsychopharmacology.
    • 12 Sep 2009 Results presented at the 22nd Annual Congress of the European College of Neuropsychopharmacology.
    • 12 Sep 2008 New trial record.
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