An 8-week, multicenter, randomized, double-blind, placebo- and paroxetine-controlled study of the efficacy, safety and tolerability of agomelatine 25 or 50 mg given once daily in the treatment of major depressive disorder (MDD) followed by a 52-week open-label treatment with agomelatine 25 or 50 mg.

Trial Profile

An 8-week, multicenter, randomized, double-blind, placebo- and paroxetine-controlled study of the efficacy, safety and tolerability of agomelatine 25 or 50 mg given once daily in the treatment of major depressive disorder (MDD) followed by a 52-week open-label treatment with agomelatine 25 or 50 mg.

Completed
Phase of Trial: Phase III

Latest Information Update: 02 May 2012

At a glance

  • Drugs Agomelatine; Paroxetine
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 18 May 2010 Actual patient number added as 501 as reported by clinicalTrials.gov.
    • 11 May 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 01 Apr 2008 Status changed from recruiting to in progress as reported by ClinicalTrials.gov.
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