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 country306 target enrollmentSeptember 2003

ConditionsMajor Depressive Disorders

Interventionsamibegron (SR58611A)placebo paroxetine

Drugsamibegron (SR58611A)placebo paroxetine

Overview

Phase: Phase 3
Intervention: amibegron (SR58611A)
Conditions: Major Depressive Disorders
Sponsor: Sanofi
Enrollment: 306
Locations: 1
Primary Endpoint: change from baseline of the total score of the HAM-D 17 items
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2003

End Date

December 2004

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Eligibility 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.

Exclusion Criteria

Not provided

Arms & Interventions

1

Intervention: amibegron (SR58611A)

2

Intervention: placebo

3

paroxetine

Intervention: paroxetine

Outcomes

Primary Outcomes

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

Time Frame: 6 weeks

Secondary Outcomes

HAM-D subscores, HAMD responders and remitters, HAM-A total score and subscores(6 weeks)
Montgomery-Asberg Depression Rating Scale (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)
AEs, Arizona Sexual Experience Scale (ASEX),(6 weeks)
laboratory parameters, physical examination findings, ECG parameters, change of vital signs, body weight(6 weeks)