Clinical trial NCT01034995: A Trial Evaluating the Efficacy and Tolerability of SSR125543 in Outpatients With Major Depressive Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depression
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-12-18
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: This duration of this trial is 11 weeks.

Eligibility 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.

Primary outcomes:
measure: Change from baseline (Day -1) to Day 56 in the 17-item HAM-D total score
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from baseline in HAM-D depressed mood item
timeFrame: 8 weeks
measure: Change from baseline in HAM-D responders (50% improvement)
timeFrame: 8 weeks
measure: Changes from baseline in the HAM-D core and factor scores
timeFrame: 8 weeks
measure: Changes from baseline in the Montgomery-Asberg depression rating scale (MADRS) total score
timeFrame: 8 weeks
measure: Changes from baseline in the Clinical Global Impression (CGI) Severity of Illness score
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Asse
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056002
city: Bruxelles
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056003
city: Liège
country: Belgium
facility: Sanofi-Aventis Investigational Site Number 056001
city: Burlington
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124011
city: Chatham
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124012
city: Edmonton
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124004
city: Gatineau
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124003
city: Kelowna
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124001
city: Mississauga
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124006
city: Penticton
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124008
city: Sherbrooke
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124007
city: Toronto
country: Canada
facility: Sanofi-Aventis Investigational Site Number 124009
city: Santiago
country: Chile
facility: Sanofi-Aventis Investigational Site Number 152001
city: Santiago
country: Chile
facility: Sanofi-Aventis Investigational Site Number 152002
city: Santiago
country: Chile
facility: Sanofi-Aventis Investigational Site Number 152003
city: Santiago
country: Chile
facility: Sanofi-Aventis Investigational Site Number 152005
city: Santiago
country: Chile
facility: Sanofi-Aventis Investigational Site Number 152006
city: Santiago
country: Chile
facility: Sanofi-Aventis Investigational Site Number 152004
city: Valparaiso
country: Chile
facility: Sanofi-Aventis Investigational Site Number 152007
city: Vina Del Mar
country: Chile
facility: Sanofi-Aventis Investigational Site Number 152008
city: Tallinn
country: Estonia
facility: Sanofi-Aventis Investigational Site Number 233001
city: Tallinn
country: Estonia
facility: Sanofi-Aventis Investigational Site Number 233002
city: Tallinn
country: Estonia
facility: Sanofi-Aventis Investigational Site Number 233004
city: Tartu
country: Estonia
facility: Sanofi-Aventis Investigational Site Number 233003
city: Helsinki
country: Finland
facility: Sanofi-Aventis Investigational Site Number 246001
city: Helsinki
country: Finland
facility: Sanofi-Aventis Investigational Site Number 246003
city: Järvenpää
country: Finland
facility: Sanofi-Aventis Investigational Site Number 246005
city: Tampere
country: Finland
facility: Sanofi-Aventis Investigational Site Number 246002
city: Turku
country: Finland
facility: Sanofi-Aventis Investigational Site Number 246004
city: Arcachon
country: France
facility: Sanofi-Aventis Investigational Site Number 250008
city: Dole
country: France
facility: Sanofi-Aventis Investigational Site Number 250007
city: Elancourt
country: France
facility: Sanofi-Aventis Investigational Site Number 250006
city: Grenoble
country: France
facility: Sanofi-Aventis Investigational Site Number 250001
city: Montpellier Cedex 05
country: France
facility: Sanofi-Aventis Investigational Site Number 250003
city: Nimes Cedex 9
country: France
facility: Sanofi-Aventis Investigational Site Number 250005
city: Orvault
country: France
facility: Sanofi-Aventis Investigational Site Number 250004
city: Toulouse
country: France
facility: Sanofi-Aventis Investigational Site Number 250002
city: Achim
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276008
city: Berlin
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276002
city: Dresden
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276004
city: Leipzig
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276005
city: Mannheim
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276006
city: München
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276007
city: Schwerin
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276001
city: Würzburg
country: Germany
facility: Sanofi-Aventis Investigational Site Number 276003
city: Den Haag
country: Netherlands
facility: Sanofi-Aventis Investigational Site Number 528001
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643006
city: Nizhny Novgorod
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643005
city: Rostov-Na-Donu
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643008
city: Saint-Petersburg
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643010
city: Samara
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643004
city: Smolensk
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643007
city: St-Petersburg
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643009
city: St-Petersburg
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643011
city: St-Petersburg
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643003
city: St-Petersburg
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643002
city: St.-Petersburg
country: Russian Federation
facility: Sanofi-Aventis Investigational Site Number 643001
city: Bratislava 2
country: Slovakia
facility: Sanofi-Aventis Investigational Site Number 703101
city: Bratislava
country: Slovakia
facility: Sanofi-Aventis Investigational Site Number 703102
city: Michalovce
country: Slovakia
facility: Sanofi-Aventis Investigational Site Number 703104
city: Rimavska Sobota
country: Slovakia
facility: Sanofi-Aventis Investigational Site Number 703105
city: Roznava
country: Slovakia
facility: Sanofi-Aventis Investigational Site Number 703103
city: Cape Town
country: South Africa
facility: Sanofi-Aventis Investigational Site Number 710005
city: Cape Town
country: South Africa
facility: Sanofi-Aventis Investigational Site Number 710001
city: Centurion
country: South Africa
facility: Sanofi-Aventis Investigational Site Number 710006
city: Durban
country: South Africa
facility: Sanofi-Aventis Investigational Site Number 710002
city: Pretoria
country: South Africa
facility: Sanofi-Aventis Investigational Site Number 710003
city: Somerset West
country: South Africa
facility: Sanofi-Aventis Investigational Site Number 710004
city: Linköping
country: Sweden
facility: Sanofi-Aventis Investigational Site Number 752004
city: Lund
country: Sweden
facility: Sanofi-Aventis Investigational Site Number 752002
city: Malmö
country: Sweden
facility: Sanofi-Aventis Investigational Site Number 752003
city: Stockholm
country: Sweden
facility: Sanofi-Aventis Investigational Site Number 752005
city: Uppsala
country: Sweden
facility: Sanofi-Aventis Investigational Site Number 752001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: