Efficacy and safety of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally for eight weeks in out-patients with severe major depressive disorder: a randomised double-blind, parallel groups, international study versus selective serotonin reuptake inhibitor (SSRI) with a double-blind extension period of 16 weeks.

Trial Profile

Efficacy and safety of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally for eight weeks in out-patients with severe major depressive disorder: a randomised double-blind, parallel groups, international study versus selective serotonin reuptake inhibitor (SSRI) with a double-blind extension period of 16 weeks.

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2013

At a glance

  • Drugs Agomelatine; Fluoxetine
  • Indications Depression; Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors IRIS
  • 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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