Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine

Phase 3

Completed

• Conditions: Major Depressive Disorders
• Interventions: Drug: amibegron (SR58611A); Drug: placebo; Drug: paroxetine

• Registration Number: NCT00825058
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Primary Completion: 2004-05
• Study Completion: 2004-10
• Study First Submitted: 2009-01-16
• Study First Submitted QC: 2009-01-16
• Study First Posted: 2009-01-19
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-24
• Last Update Posted: 2009-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	amibegron (SR58611A)	-
2	placebo	-
3	paroxetine	-

Primary Outcome Measures

Name	Time	Method
change from baseline of the total score of the HAM-D 17 items.	6 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇷🇸 Belgrade, Serbia