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Efficacy and safety of three dose regimens of agomelatine (10, 25, 25 - 50 mg) versus placebo given once a day for 6 weeks in out-patients suffering from moderate to severe major depressive disorder: a 6-week randomised, double-blind, placebo-controlled, parallel groups study followed by a double-blind optional 18-week extension period.

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Trial Profile

Efficacy and safety of three dose regimens of agomelatine (10, 25, 25 - 50 mg) versus placebo given once a day for 6 weeks in out-patients suffering from moderate to severe major depressive disorder: a 6-week randomised, double-blind, placebo-controlled, parallel groups study followed by a double-blind optional 18-week extension period.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Oct 2022

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At a glance

  • Drugs Agomelatine (Primary)
  • Indications Major depressive disorder
  • Focus Pharmacogenomic; Therapeutic Use
  • Sponsors Servier

Most Recent Events

  • 21 Oct 2014 Primary endpoint (Hamilton Depression Rating Scale score at week 6) has been met according to results presented at the 27th Annual Congress of the European College of Neuropsychopharmacology.
  • 21 Oct 2014 Results presented at the 27th Annual Congress of the European College of Neuropsychopharmacology.
  • 31 Jan 2014 Results published in the European Neuropsychopharmacology.

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