Efficacy and safety of agomelatine oral administration (25 to 50 mg/day) in elderly patients suffering from major depressive disorder: an 8-week, randomised, double-blind, flexible-dose, parallel groups, placebo-controlled, international, multicentre study followed by an extension double-blind treatment period of 16 weeks.

Trial Profile

Efficacy and safety of agomelatine oral administration (25 to 50 mg/day) in elderly patients suffering from major depressive disorder: an 8-week, randomised, double-blind, flexible-dose, parallel groups, placebo-controlled, international, multicentre study followed by an extension double-blind treatment period of 16 weeks.

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Apr 2017

At a glance

  • Drugs Agomelatine (Primary)
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Servier
  • Most Recent Events

    • 05 Apr 2017 Results assessing safety and efficacy of Agomelatine using patient data from two phase III trials (ISRCTN57507360 and see CTP 283683), published in the International Clinical Psychopharmacology
    • 21 Oct 2014 Results of 24 weeks agomelatine treatment presented at the 27th Annual Congress of the European College of Neuropsychopharmacology.
    • 01 Jun 2013 Primary endpoint 'Hamilton-Depression-Rating-Scale' has been met.
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