A Randomized, Double-blind, Two-arm Study Comparing the Efficacy and Safety of Trazodone Contramid OAD and Placebo in the Treatment of Unipolar Major Depressive Disorder.

Trial Profile

A Randomized, Double-blind, Two-arm Study Comparing the Efficacy and Safety of Trazodone Contramid OAD and Placebo in the Treatment of Unipolar Major Depressive Disorder.

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jan 2011

At a glance

  • Drugs Trazodone (Primary)
  • Indications Depression; Depressive disorders; Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Altus Formulation Inc
  • Most Recent Events

    • 20 Jan 2011 Labopharm received Health Canada Approval for Oleptro for the treatment of MDD based on results of this study, according to a Labopharm media release
    • 05 Feb 2010 The US FDA has approved Oleptro (trazodone) for the treatment of major depressive disorder.
    • 05 Aug 2009 An NDA has been submitted to Health Canada based on positive data from this trial and five pivotal pharmacokinetic studies.
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