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.
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
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History