Efficacy and safety of agomelatine given orally compared to placebo, in addition to a mood stabiliser in bipolar I patients with a current major depressive episode. An eight week randomised, double-blind, controlled, parallel group study followed by a double-blind extension treatment period up to one year

Trial Profile

Efficacy and safety of agomelatine given orally compared to placebo, in addition to a mood stabiliser in bipolar I patients with a current major depressive episode. An eight week randomised, double-blind, controlled, parallel group study followed by a double-blind extension treatment period up to one year

Completed
Phase of Trial: Phase III

Latest Information Update: 10 Aug 2017

At a glance

  • Drugs Agomelatine (Primary)
  • Indications Bipolar I disorders
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 31 Dec 2008 Status is now completed, according to ISRCTN: Current Controlled Trials.
    • 17 Nov 2006 New trial record.
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