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.
Phase of Trial: Phase III
Latest Information Update: 21 Dec 2017
At a glance
- Drugs Agomelatine; Fluoxetine
- Indications Depression; Major depressive disorder
- Focus Registrational; Therapeutic Use
- Sponsors IRIS
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History