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
Price :
$35
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At a glance
- Drugs Agomelatine (Primary) ; Fluoxetine
- Indications Major depressive disorder
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors IRIS; Servier
- 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.