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Efficacy and safety of agomelatine (25 mg/day with potential blinded adjustment to 50 mg/day) for 12 weeks in non-depressed out-patients with Generalized Anxiety Disorder. A 12-week randomised, double-blind, placebo-controlled, with escitalopram (10 mg/day with potential blinded adjustment to 20 mg/day) as validator, 3-arm parallel groups, international multicenter study.

Trial Profile

Efficacy and safety of agomelatine (25 mg/day with potential blinded adjustment to 50 mg/day) for 12 weeks in non-depressed out-patients with Generalized Anxiety Disorder. A 12-week randomised, double-blind, placebo-controlled, with escitalopram (10 mg/day with potential blinded adjustment to 20 mg/day) as validator, 3-arm parallel groups, international multicenter study.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Oct 2022

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At a glance

  • Drugs Agomelatine (Primary) ; Escitalopram
  • Indications Generalised anxiety disorder
  • Focus Pharmacogenomic; Registrational; Therapeutic Use

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.
  • 07 Jun 2012 Results reported at the 28th International Congress of Cellegium Internationale Neuro-Psychopharmacologicum.
  • 18 Aug 2011 Additional trial locations identified as reported by ISRCTN: Current Controlled Trials.

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