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Efficacy and safety of 2 doses of agomelatine (10 mg/day or 25 mg/day) versus placebo given orally for 12 weeks in non depressed out-patients with Generalized Anxiety Disorder. A 12-week randomised, double-blind, placebo-controlled, 3-arm parallel groups, international multicenter study

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Trial Profile

Efficacy and safety of 2 doses of agomelatine (10 mg/day or 25 mg/day) versus placebo given orally for 12 weeks in non depressed out-patients with Generalized Anxiety Disorder. A 12-week randomised, double-blind, placebo-controlled, 3-arm parallel groups, international multicenter study

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Feb 2021

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At a glance

  • Drugs Agomelatine (Primary)
  • Indications Generalised anxiety disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors IRIS; Servier

    • Most Recent Events

    • 04 Feb 2021 Results of meta-analysis of 3 studies (EudraCT2004-002577-23; ISRCTN03554974; EudraCT2012-001666-15) assessing effects of agomelatine on anxious symptoms and functional impairment, published in the Advances in Therapy.
    • 12 Mar 2017 Results published in the European Neuropsychopharmacology
    • 20 Sep 2016 Primary endpoint has been met. (HAM-A total score)

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