NCT00775203

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: Phase 3
• Study type: Interventional
• Enrollment: 412 (actual)
• Sponsor: Labopharm Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to demonstrate efficacy, safety and clinical benefit of Trazodone Contramid® OAD (Once A Day) in the treatment of Unipolar Major Depressive Disorder (MDD).

Detailed description

This two-arm, multicentre, randomized, placebo-controlled, double-blind, parallel-design study consisted of a baseline phase (screening and wash-out) and a double-blind randomized phase (randomization to Trazodone Contramid® OAD or placebo). The total study duration including wash-out of prohibited medications was approximately 11 weeks; the total duration of the randomized phase was 8 weeks (titration: 2 weeks + treatment: 6 weeks).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Trazodone Hydrochloride (HCl) Extended-Release Tablets
DRUG	Placebo

Timeline

• Start date: 2007-06-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2008-10-20
• Last updated: 2012-04-27
• Results posted: 2010-04-07

Locations

36 sites across 2 countries: United States, Canada