A Trial Evaluating the Efficacy and Tolerability of SSR125543 in Outpatients With Major Depressive Disorder
NCT ID: NCT01034995
Last Updated: 2011-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
580 participants
INTERVENTIONAL
2010-02-28
2011-03-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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SSR125543 20 mg
1 capsule of SSR125543 20 mg + 1 capsule of placebo
SSR125543
Pharmaceutical form: capsule
Route of administration: oral
SSR125543 50 mg
1 capsule of SSR125543 50 mg + 1 capsule of placebo
SSR125543
Pharmaceutical form: capsule
Route of administration: oral
SSR125543 100 mg
2 capsules of SSR125543 50 mg
SSR125543
Pharmaceutical form: capsule
Route of administration: oral
escitalopram 10 mg
1 capsule of escitalopram 10 mg + 1 capsule of placebo
escitalopram
Pharmaceutical form: encapsulated tablets
Route of administration: oral
placebo
2 capsules of placebo
placebo
Pharmaceutical form: capsule
Route of administration: oral
Interventions
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SSR125543
Pharmaceutical form: capsule
Route of administration: oral
escitalopram
Pharmaceutical form: encapsulated tablets
Route of administration: oral
placebo
Pharmaceutical form: capsule
Route of administration: oral
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
64 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Investigational Site Number 056002
Asse, , Belgium
Sanofi-Aventis Investigational Site Number 056003
Brussels, , Belgium
Sanofi-Aventis Investigational Site Number 056001
Liège, , Belgium
Sanofi-Aventis Investigational Site Number 124011
Burlington, , Canada
Sanofi-Aventis Investigational Site Number 124012
Chatham, , Canada
Sanofi-Aventis Investigational Site Number 124004
Edmonton, , Canada
Sanofi-Aventis Investigational Site Number 124003
Gatineau, , Canada
Sanofi-Aventis Investigational Site Number 124001
Kelowna, , Canada
Sanofi-Aventis Investigational Site Number 124006
Mississauga, , Canada
Sanofi-Aventis Investigational Site Number 124008
Penticton, , Canada
Sanofi-Aventis Investigational Site Number 124007
Sherbrooke, , Canada
Sanofi-Aventis Investigational Site Number 124009
Toronto, , Canada
Sanofi-Aventis Investigational Site Number 152001
Santiago, , Chile
Sanofi-Aventis Investigational Site Number 152002
Santiago, , Chile
Sanofi-Aventis Investigational Site Number 152003
Santiago, , Chile
Sanofi-Aventis Investigational Site Number 152005
Santiago, , Chile
Sanofi-Aventis Investigational Site Number 152006
Santiago, , Chile
Sanofi-Aventis Investigational Site Number 152004
Santiago, , Chile
Sanofi-Aventis Investigational Site Number 152007
Valparaíso, , Chile
Sanofi-Aventis Investigational Site Number 152008
Viña del Mar, , Chile
Sanofi-Aventis Investigational Site Number 233001
Tallinn, , Estonia
Sanofi-Aventis Investigational Site Number 233002
Tallinn, , Estonia
Sanofi-Aventis Investigational Site Number 233004
Tallinn, , Estonia
Sanofi-Aventis Investigational Site Number 233003
Tartu, , Estonia
Sanofi-Aventis Investigational Site Number 246001
Helsinki, , Finland
Sanofi-Aventis Investigational Site Number 246003
Helsinki, , Finland
Sanofi-Aventis Investigational Site Number 246005
Järvenpää, , Finland
Sanofi-Aventis Investigational Site Number 246002
Tampere, , Finland
Sanofi-Aventis Investigational Site Number 246004
Turku, , Finland
Sanofi-Aventis Investigational Site Number 250008
Arcachon, , France
Sanofi-Aventis Investigational Site Number 250007
Dole, , France
Sanofi-Aventis Investigational Site Number 250006
Élancourt, , France
Sanofi-Aventis Investigational Site Number 250001
Grenoble, , France
Sanofi-Aventis Investigational Site Number 250003
Montpellier, , France
Sanofi-Aventis Investigational Site Number 250005
Nîmes, , France
Sanofi-Aventis Investigational Site Number 250004
Orvault, , France
Sanofi-Aventis Investigational Site Number 250002
Toulouse, , France
Sanofi-Aventis Investigational Site Number 276008
Achim, , Germany
Sanofi-Aventis Investigational Site Number 276002
Berlin, , Germany
Sanofi-Aventis Investigational Site Number 276004
Dresden, , Germany
Sanofi-Aventis Investigational Site Number 276005
Leipzig, , Germany
Sanofi-Aventis Investigational Site Number 276006
Mannheim, , Germany
Sanofi-Aventis Investigational Site Number 276007
München, , Germany
Sanofi-Aventis Investigational Site Number 276001
Schwerin, , Germany
Sanofi-Aventis Investigational Site Number 276003
Würzburg, , Germany
Sanofi-Aventis Investigational Site Number 528001
The Hague, , Netherlands
Sanofi-Aventis Investigational Site Number 643006
Moscow, , Russia
Sanofi-Aventis Investigational Site Number 643005
Nizhny Novgorod, , Russia
Sanofi-Aventis Investigational Site Number 643008
Rostov-on-Don, , Russia
Sanofi-Aventis Investigational Site Number 643001
Saint Petersburg, , Russia
Sanofi-Aventis Investigational Site Number 643009
Saint Petersburg, , Russia
Sanofi-Aventis Investigational Site Number 643010
Saint Petersburg, , Russia
Sanofi-Aventis Investigational Site Number 643011
Saint Petersburg, , Russia
Sanofi-Aventis Investigational Site Number 643003
Saint Petersburg, , Russia
Sanofi-Aventis Investigational Site Number 643002
Saint Petersburg, , Russia
Sanofi-Aventis Investigational Site Number 643004
Samara, , Russia
Sanofi-Aventis Investigational Site Number 643007
Smolensk, , Russia
Sanofi-Aventis Investigational Site Number 703102
Bratislava, , Slovakia
Sanofi-Aventis Investigational Site Number 703101
Bratislava, , Slovakia
Sanofi-Aventis Investigational Site Number 703104
Michalovce, , Slovakia
Sanofi-Aventis Investigational Site Number 703105
Rimavská Sobota, , Slovakia
Sanofi-Aventis Investigational Site Number 703103
Rožňava, , Slovakia
Sanofi-Aventis Investigational Site Number 710005
Cape Town, , South Africa
Sanofi-Aventis Investigational Site Number 710001
Cape Town, , South Africa
Sanofi-Aventis Investigational Site Number 710006
Centurion, , South Africa
Sanofi-Aventis Investigational Site Number 710002
Durban, , South Africa
Sanofi-Aventis Investigational Site Number 710003
Pretoria, , South Africa
Sanofi-Aventis Investigational Site Number 710004
Somerset West, , South Africa
Sanofi-Aventis Investigational Site Number 752004
Linköping, , Sweden
Sanofi-Aventis Investigational Site Number 752002
Lund, , Sweden
Sanofi-Aventis Investigational Site Number 752003
Malmo, , Sweden
Sanofi-Aventis Investigational Site Number 752005
Stockholm, , Sweden
Sanofi-Aventis Investigational Site Number 752001
Uppsala, , Sweden
Countries
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Other Identifiers
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2009-010339-42
Identifier Type: OTHER
Identifier Source: secondary_id
DFI5687
Identifier Type: -
Identifier Source: org_study_id
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