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

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Amibegron; Paroxetine

Criteria

Inclusion Criteria:

• patients suffering from a recurrent major depressive episode of at least moderate intensity (DSM-IV)

• patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months.

• the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration.