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Efficacy and safety of 3 doses (0.25, 0.5 and 1mg/day) of agomelatine sublingual administration over an 8-week treatment period, in out-patients with Major Depressive Disorder. An 8-week randomised, double-blind, fixed dose, international multicentre, placebo-controlled study with parallel groups, followed by an extension double-blind treatment period of 16 weeks.

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Trial Profile

Efficacy and safety of 3 doses (0.25, 0.5 and 1mg/day) of agomelatine sublingual administration over an 8-week treatment period, in out-patients with Major Depressive Disorder. An 8-week randomised, double-blind, fixed dose, international multicentre, placebo-controlled study with parallel groups, followed by an extension double-blind treatment period of 16 weeks.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Oct 2021

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At a glance

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

Most Recent Events

  • 03 Nov 2012 Planned number of patients changed from 540 to 640 as reported by European Clinical Trials Database.
  • 28 Jun 2012 Actual initiation date changed from 19 Feb 2010 to 12 Jan 2010 and additional locations added as reported by European Clinical Trials Database.
  • 28 Jun 2012 Actual end date (12 Jan 2012) added as reported by European Clinical Trials Database.

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