NCT00825058

Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine

A Double-Blind, Multicenter Study Evaluating the Efficacy and Safety of One Fixed Dose of SR58611A (700 mg/Day) Versus Placebo and Paroxetine (20 mg/Day) in Patients With a Recurrent Major Depressive Episode.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 317 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Primary objective : * To demonstrate the antidepressant efficacy on the Hamilton Depression Rating Scale of SR58611A 700mg/day compared with placebo in the treatment of patients with a recurrent major depressive episode. Secondary objectives: * To assess the safety profile of SR58611A 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.

Conditions

• Major Depressive Disorders

Interventions

Type	Name	Description
DRUG	amibegron (SR58611A)	oral administration 2 X 350mg/day at 12 hours intervals
DRUG	placebo	oral administration 12 hours intervals
DRUG	paroxetine	oral 20 mg/day

Timeline

• Start date: 2003-11-01
• Primary completion: 2004-05-01
• Completion: 2004-10-01
• First posted: 2009-01-19
• Last updated: 2009-03-25

Locations

8 sites across 8 countries: Bulgaria, Croatia, Czechia, Estonia, France, Montenegro, Netherlands, Serbia