A Trial Evaluating the Efficacy and Tolerability of SSR125543 in Outpatients With Major Depressive Disorder (AGATE)

April 13, 2011 updated by: Sanofi

An Eight-week, Multinational, Multicenter, Double-blind, Active- and Placebo-controlled Clinical Trial Evaluating the Efficacy and Tolerability of Three Fixed Doses of SSR125543 (20 mg Daily, 50 mg Daily and 100 mg Daily) in Outpatients With Major Depressive Disorder

Primary Objective:

  • To evaluate the efficacy of three fixed doses of SSR125543 (20 mg daily, 50 mg daily, and 100 mg daily) compared to placebo in outpatients with major depressive disorder, as assessed by the change from baseline (Day -1) to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.

Secondary Objectives:

  • To evaluate the tolerability and safety of SSR125543 in outpatients with major depressive disorder
  • To evaluate plasma concentrations of SSR125543

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This duration of this trial is 11 weeks.

Study Type

Interventional

Enrollment (Anticipated)

580

Phase

  • Phase 2

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

  • Belgium
      • Asse, Belgium, 1730
        • Sanofi-Aventis Investigational Site Number 056002
      • Bruxelles, Belgium, 1180
        • Sanofi-Aventis Investigational Site Number 056003
      • Liège, Belgium, 4000
        • Sanofi-Aventis Investigational Site Number 056001
  • Canada
      • Burlington, Canada, L7R 4E2
        • Sanofi-Aventis Investigational Site Number 124011
      • Chatham, Canada, N7M 1B7
        • Sanofi-Aventis Investigational Site Number 124012
      • Edmonton, Canada, T6L 5X8
        • Sanofi-Aventis Investigational Site Number 124004
      • Gatineau, Canada, J9A 1K7
        • Sanofi-Aventis Investigational Site Number 124003
      • Kelowna, Canada, V1Y 1Z9
        • Sanofi-Aventis Investigational Site Number 124001
      • Mississauga, Canada, L5M 4N4
        • Sanofi-Aventis Investigational Site Number 124006
      • Penticton, Canada, V2A 4M4
        • Sanofi-Aventis Investigational Site Number 124008
      • Sherbrooke, Canada, J1V 4J7
        • Sanofi-Aventis Investigational Site Number 124007
      • Toronto, Canada, M3H 5S4
        • Sanofi-Aventis Investigational Site Number 124009
  • Chile
      • Santiago, Chile, 750-0710
        • Sanofi-Aventis Investigational Site Number 152001
      • Santiago, Chile, 751-0041
        • Sanofi-Aventis Investigational Site Number 152002
      • Santiago, Chile, 756-0356
        • Sanofi-Aventis Investigational Site Number 152003
      • Santiago, Chile, 8053095
        • Sanofi-Aventis Investigational Site Number 152005
      • Santiago, Chile, 890-0085
        • Sanofi-Aventis Investigational Site Number 152006
      • Santiago, Chile
        • Sanofi-Aventis Investigational Site Number 152004
      • Valparaiso, Chile, 236-0002
        • Sanofi-Aventis Investigational Site Number 152007
      • Vina Del Mar, Chile
        • Sanofi-Aventis Investigational Site Number 152008
  • Estonia
      • Tallinn, Estonia, 10613
        • Sanofi-Aventis Investigational Site Number 233001
      • Tallinn, Estonia, 11911
        • Sanofi-Aventis Investigational Site Number 233002
      • Tallinn, Estonia, 13419
        • Sanofi-Aventis Investigational Site Number 233004
      • Tartu, Estonia, 50406
        • Sanofi-Aventis Investigational Site Number 233003
  • Finland
      • Helsinki, Finland, 00260
        • Sanofi-Aventis Investigational Site Number 246001
      • Helsinki, Finland, 00530
        • Sanofi-Aventis Investigational Site Number 246003
      • Järvenpää, Finland, 04400
        • Sanofi-Aventis Investigational Site Number 246005
      • Tampere, Finland, 33200
        • Sanofi-Aventis Investigational Site Number 246002
      • Turku, Finland, 20100
        • Sanofi-Aventis Investigational Site Number 246004
  • France
      • Arcachon, France, 33120
        • Sanofi-Aventis Investigational Site Number 250008
      • Dole, France, 39100
        • Sanofi-Aventis Investigational Site Number 250007
      • Elancourt, France, 78990
        • Sanofi-Aventis Investigational Site Number 250006
      • Grenoble, France, 38043
        • Sanofi-Aventis Investigational Site Number 250001
      • Montpellier Cedex 05, France, 34295
        • Sanofi-Aventis Investigational Site Number 250003
      • Nimes Cedex 9, France, 30029
        • Sanofi-Aventis Investigational Site Number 250005
      • Orvault, France, 44700
        • Sanofi-Aventis Investigational Site Number 250004
      • Toulouse, France, 31000
        • Sanofi-Aventis Investigational Site Number 250002
  • Germany
      • Achim, Germany, 28832
        • Sanofi-Aventis Investigational Site Number 276008
      • Berlin, Germany, 10629
        • Sanofi-Aventis Investigational Site Number 276002
      • Dresden, Germany, 01307
        • Sanofi-Aventis Investigational Site Number 276004
      • Leipzig, Germany, 04107
        • Sanofi-Aventis Investigational Site Number 276005
      • Mannheim, Germany, 68159
        • Sanofi-Aventis Investigational Site Number 276006
      • München, Germany, 80333
        • Sanofi-Aventis Investigational Site Number 276007
      • Schwerin, Germany, 19053
        • Sanofi-Aventis Investigational Site Number 276001
      • Würzburg, Germany, 97070
        • Sanofi-Aventis Investigational Site Number 276003
  • Netherlands
      • Den Haag, Netherlands, 2512 VA
        • Sanofi-Aventis Investigational Site Number 528001
  • Russian Federation
      • Moscow, Russian Federation, 117152
        • Sanofi-Aventis Investigational Site Number 643006
      • Nizhny Novgorod, Russian Federation, 603155
        • Sanofi-Aventis Investigational Site Number 643005
      • Rostov-Na-Donu, Russian Federation, 344010
        • Sanofi-Aventis Investigational Site Number 643008
      • Saint-Petersburg, Russian Federation, 190121
        • Sanofi-Aventis Investigational Site Number 643010
      • Samara, Russian Federation, 443016
        • Sanofi-Aventis Investigational Site Number 643004
      • Smolensk, Russian Federation, 214019
        • Sanofi-Aventis Investigational Site Number 643007
      • St-Petersburg, Russian Federation, 190121
        • Sanofi-Aventis Investigational Site Number 643009
      • St-Petersburg, Russian Federation, 191119
        • Sanofi-Aventis Investigational Site Number 643011
      • St-Petersburg, Russian Federation, 192019
        • Sanofi-Aventis Investigational Site Number 643003
      • St-Petersburg, Russian Federation, 194044
        • Sanofi-Aventis Investigational Site Number 643002
      • St.-Petersburg, Russian Federation, 190005
        • Sanofi-Aventis Investigational Site Number 643001
  • Slovakia
      • Bratislava, Slovakia, 81107
        • Sanofi-Aventis Investigational Site Number 703102
      • Bratislava 2, Slovakia, 82606
        • Sanofi-Aventis Investigational Site Number 703101
      • Michalovce, Slovakia, 07101
        • Sanofi-Aventis Investigational Site Number 703104
      • Rimavska Sobota, Slovakia, 979 12
        • Sanofi-Aventis Investigational Site Number 703105
      • Roznava, Slovakia, 04801
        • Sanofi-Aventis Investigational Site Number 703103
  • South Africa
      • Cape Town, South Africa, 7530
        • Sanofi-Aventis Investigational Site Number 710005
      • Cape Town, South Africa, 7646
        • Sanofi-Aventis Investigational Site Number 710001
      • Centurion, South Africa, 0157
        • Sanofi-Aventis Investigational Site Number 710006
      • Durban, South Africa, 3629
        • Sanofi-Aventis Investigational Site Number 710002
      • Pretoria, South Africa, 0181
        • Sanofi-Aventis Investigational Site Number 710003
      • Somerset West, South Africa, 7130
        • Sanofi-Aventis Investigational Site Number 710004
  • Sweden
      • Linköping, Sweden, 582 16
        • Sanofi-Aventis Investigational Site Number 752004
      • Lund, Sweden, 223 61
        • Sanofi-Aventis Investigational Site Number 752002
      • Malmö, Sweden, 211 52
        • Sanofi-Aventis Investigational Site Number 752003
      • Stockholm, Sweden, 112 34
        • Sanofi-Aventis Investigational Site Number 752005
      • Uppsala, Sweden, 753 10
        • Sanofi-Aventis Investigational Site Number 752001

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 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients with a diagnosis of major depressive disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria (296.3) and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI).

Exclusion criteria:

  • Inpatient hospitalization at screening
  • Symptoms of depression present for <30 days or >2 years
  • Significant suicide risk
  • Mild depression as measured by standard clinical research scales
  • History of failure to respond to antidepressant treatment
  • Other psychiatric conditions that could obscure the results of the study
  • For women of child-bearing potential, the unwillingness to use highly effective means of birth control

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SSR125543 20 mg
1 capsule of SSR125543 20 mg + 1 capsule of placebo
Drug: SSR125543

Pharmaceutical form: capsule

Route of administration: oral
Experimental: SSR125543 50 mg
1 capsule of SSR125543 50 mg + 1 capsule of placebo
Drug: SSR125543

Pharmaceutical form: capsule

Route of administration: oral
Experimental: SSR125543 100 mg
2 capsules of SSR125543 50 mg
Drug: SSR125543

Pharmaceutical form: capsule

Route of administration: oral
Active Comparator: escitalopram 10 mg
1 capsule of escitalopram 10 mg + 1 capsule of placebo
Drug: escitalopram

Pharmaceutical form: encapsulated tablets

Route of administration: oral
Placebo Comparator: placebo
2 capsules of placebo
Drug: placebo

Pharmaceutical form: capsule

Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline (Day -1) to Day 56 in the 17-item HAM-D total score
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in HAM-D depressed mood item
Time Frame: 8 weeks
8 weeks
Change from baseline in HAM-D responders (50% improvement)
Time Frame: 8 weeks
8 weeks
Changes from baseline in the HAM-D core and factor scores
Time Frame: 8 weeks
8 weeks
Changes from baseline in the Montgomery-Asberg depression rating scale (MADRS) total score
Time Frame: 8 weeks
8 weeks
Changes from baseline in the Clinical Global Impression (CGI) Severity of Illness score
Time Frame: 8 weeks
8 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

February 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

December 17, 2009

First Submitted That Met QC Criteria

December 17, 2009

First Posted (Estimate)

December 18, 2009

Study Record Updates

Last Update Posted (Estimate)

April 14, 2011

Last Update Submitted That Met QC Criteria

April 13, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFI5687
  • 2009-010339-42 (Other Identifier: EMEA)

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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