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

Phase 3

Completed

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

• Registration Number: NCT00825019
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2004-10
• Study Completion: 2004-12
• 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: 306

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇺🇸 Bridgewater, New Jersey, United States