Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine

March 24, 2009 updated by: Sanofi

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

317

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria
        • Sanofi-Aventis Administrative Office
  • Croatia
      • Zagreb, Croatia
        • Sanofi-Aventis Administrative Office
  • Czech Republic
      • Praha, Czech Republic
        • Sanofi-Aventis Administrative Office
  • Estonia
      • Tallinn, Estonia
        • Sanofi-Aventis Administrative Office
  • France
      • Paris, France
        • Sanofi-Aventis Administrative Office
  • Montenegro
      • Montenegro, Montenegro
        • Sanofi-Aventis Administrative Office
  • Netherlands
      • Gouda, Netherlands
        • Sanofi-Aventis Administrative Office
  • Serbia
      • Belgrade, Serbia
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: amibegron (SR58611A)
oral administration 2 X 350mg/day at 12 hours intervals
Placebo Comparator: 2
Drug: placebo
oral administration 12 hours intervals
Active Comparator: 3
Drug: paroxetine
oral 20 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change from baseline of the total score of the HAM-D 17 items.
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

May 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

January 16, 2009

First Submitted That Met QC Criteria

January 16, 2009

First Posted (Estimate)

January 19, 2009

Study Record Updates

Last Update Posted (Estimate)

March 25, 2009

Last Update Submitted That Met QC Criteria

March 24, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC5374

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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