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.

Sanofi1 site in 1 country317 target enrollmentNovember 2003

Overview

Phase: Phase 3
Intervention: placebo
Conditions: Major Depressive Disorders
Sponsor: Sanofi
Enrollment: 317
Locations: 1
Primary Endpoint: change from baseline of the total score of the HAM-D 17 items.
Status: Completed
Last Updated: 17 years ago

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.

Registry

clinicaltrials.gov

Start Date

November 2003

End Date

October 2004

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

•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

Intervention: placebo

Intervention: amibegron (SR58611A)

Intervention: paroxetine

change from baseline of the total score of the HAM-D 17 items.

Time Frame: 6 weeks

HAM-D subscores(6 weeks)
HAM-D responders and remitters(6 weeks)
HAM-A total score and subscores(6 weeks)
MADRS total score(6 weeks)
clinical global impression (CGI) severity and improvement scores(6 weeks)
patient global impression (PGI) improvement score(6 weeks)
social and occupational functioning assessment scale (SOFAS) score(6 weeks)
clinical monitoring of adverse events (AEs)(6 weeks)
laboratory parameters(6 weeks)
electrocardiogram (ECG) parameters, change in vital signs and body weight(6 weeks)