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

Major Depression Clinical Trial

— AGATE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01034995
• Other study ID #: DFI5687
• Secondary ID: 2009-010339-42
• Status: Completed
• Phase: Phase 2
• First received: December 17, 2009
• Last updated: April 13, 2011
• Start date: February 2010
• Est. completion date: March 2011

Study information

• Verified date: April 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

Description:

This duration of this trial is 11 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 580
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Belgium	Sanofi-Aventis Investigational Site Number 056002	Asse
Belgium	Sanofi-Aventis Investigational Site Number 056003	Bruxelles
Belgium	Sanofi-Aventis Investigational Site Number 056001	Liège
Canada	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
Chile	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 152004	Santiago
Chile	Sanofi-Aventis Investigational Site Number 152005	Santiago
Chile	Sanofi-Aventis Investigational Site Number 152006	Santiago
Chile	Sanofi-Aventis Investigational Site Number 152007	Valparaiso
Chile	Sanofi-Aventis Investigational Site Number 152008	Vina Del Mar
Estonia	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
Finland	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
France	Sanofi-Aventis Investigational Site Number 250008	Arcachon
France	Sanofi-Aventis Investigational Site Number 250007	Dole
France	Sanofi-Aventis Investigational Site Number 250006	Elancourt
France	Sanofi-Aventis Investigational Site Number 250001	Grenoble
France	Sanofi-Aventis Investigational Site Number 250003	Montpellier Cedex 05
France	Sanofi-Aventis Investigational Site Number 250005	Nimes Cedex 9
France	Sanofi-Aventis Investigational Site Number 250004	Orvault
France	Sanofi-Aventis Investigational Site Number 250002	Toulouse
Germany	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
Netherlands	Sanofi-Aventis Investigational Site Number 528001	Den Haag
Russian Federation	Sanofi-Aventis Investigational Site Number 643006	Moscow
Russian Federation	Sanofi-Aventis Investigational Site Number 643005	Nizhny Novgorod
Russian Federation	Sanofi-Aventis Investigational Site Number 643008	Rostov-Na-Donu
Russian Federation	Sanofi-Aventis Investigational Site Number 643010	Saint-Petersburg
Russian Federation	Sanofi-Aventis Investigational Site Number 643004	Samara
Russian Federation	Sanofi-Aventis Investigational Site Number 643007	Smolensk
Russian Federation	Sanofi-Aventis Investigational Site Number 643002	St-Petersburg
Russian Federation	Sanofi-Aventis Investigational Site Number 643003	St-Petersburg
Russian Federation	Sanofi-Aventis Investigational Site Number 643009	St-Petersburg
Russian Federation	Sanofi-Aventis Investigational Site Number 643011	St-Petersburg
Russian Federation	Sanofi-Aventis Investigational Site Number 643001	St.-Petersburg
Slovakia	Sanofi-Aventis Investigational Site Number 703102	Bratislava
Slovakia	Sanofi-Aventis Investigational Site Number 703101	Bratislava 2
Slovakia	Sanofi-Aventis Investigational Site Number 703104	Michalovce
Slovakia	Sanofi-Aventis Investigational Site Number 703105	Rimavska Sobota
Slovakia	Sanofi-Aventis Investigational Site Number 703103	Roznava
South Africa	Sanofi-Aventis Investigational Site Number 710001	Cape Town
South Africa	Sanofi-Aventis Investigational Site Number 710005	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
Sweden	Sanofi-Aventis Investigational Site Number 752004	Linköping
Sweden	Sanofi-Aventis Investigational Site Number 752002	Lund
Sweden	Sanofi-Aventis Investigational Site Number 752003	Malmö
Sweden	Sanofi-Aventis Investigational Site Number 752005	Stockholm
Sweden	Sanofi-Aventis Investigational Site Number 752001	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Belgium,  Canada,  Chile,  Estonia,  Finland,  France,  Germany,  Netherlands,  Russian Federation,  Slovakia,  South Africa,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline (Day -1) to Day 56 in the 17-item HAM-D total score		8 weeks	No
Secondary	Change from baseline in HAM-D depressed mood item		8 weeks	No
Secondary	Change from baseline in HAM-D responders (50% improvement)		8 weeks	No
Secondary	Changes from baseline in the HAM-D core and factor scores		8 weeks	No
Secondary	Changes from baseline in the Montgomery-Asberg depression rating scale (MADRS) total score		8 weeks	No
Secondary	Changes from baseline in the Clinical Global Impression (CGI) Severity of Illness score		8 weeks	No