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.
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 24 Jan 2011
Price :
$35
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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.