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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT01034995
First received: December 17, 2009
Last updated: April 13, 2011
Last verified: April 2011
  Purpose

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

Condition Intervention Phase
Major Depression
Drug: SSR125543
Drug: escitalopram
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline (Day -1) to Day 56 in the 17-item HAM-D total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in HAM-D depressed mood item [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in HAM-D responders (50% improvement) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in the HAM-D core and factor scores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in the Montgomery-Asberg depression rating scale (MADRS) total score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in the Clinical Global Impression (CGI) Severity of Illness score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 580
Study Start Date: February 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Detailed Description:

This duration of this trial is 11 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034995

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

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT01034995     History of Changes
Other Study ID Numbers: DFI5687, 2009-010339-42
Study First Received: December 17, 2009
Last Updated: April 13, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on July 22, 2014