Efficacy and Safety of One Single Dose of SR58611 Compared to Placebo and Paroxetine

Summary

Primary objective is to demonstrate the antidepressant efficacy on the Hamilton depression rating scale (HAM-D) of amibegron (SR58611) 700 mg/day compared to placebo in the treatment of patients with a recurrent major depressive episode (MDD). Secondary objective is to assess the safety profile of amibegron 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.

Timeline

Start

2003-09

Primary completion

2004-10

Completion

2004-12

Drugs

Indications