drugset / Trial / NCT00825058

Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine

NCT00825058

Phase 3 Completed 317 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2003-11
Primary completion
2004-05
Completion
2004-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Paroxetine Small molecule 20 mg Oral
Subject amibegron Small molecule 350 mg Oral