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

Primary Purpose

Major Depression

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SSR125543
escitalopram
placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Investigational Site Number 056002
  • Sanofi-Aventis Investigational Site Number 056003
  • Sanofi-Aventis Investigational Site Number 056001
  • Sanofi-Aventis Investigational Site Number 124011
  • Sanofi-Aventis Investigational Site Number 124012
  • Sanofi-Aventis Investigational Site Number 124004
  • Sanofi-Aventis Investigational Site Number 124003
  • Sanofi-Aventis Investigational Site Number 124001
  • Sanofi-Aventis Investigational Site Number 124006
  • Sanofi-Aventis Investigational Site Number 124008
  • Sanofi-Aventis Investigational Site Number 124007
  • Sanofi-Aventis Investigational Site Number 124009
  • Sanofi-Aventis Investigational Site Number 152001
  • Sanofi-Aventis Investigational Site Number 152002
  • Sanofi-Aventis Investigational Site Number 152003
  • Sanofi-Aventis Investigational Site Number 152005
  • Sanofi-Aventis Investigational Site Number 152006
  • Sanofi-Aventis Investigational Site Number 152004
  • Sanofi-Aventis Investigational Site Number 152007
  • Sanofi-Aventis Investigational Site Number 152008
  • Sanofi-Aventis Investigational Site Number 233001
  • Sanofi-Aventis Investigational Site Number 233002
  • Sanofi-Aventis Investigational Site Number 233004
  • Sanofi-Aventis Investigational Site Number 233003
  • Sanofi-Aventis Investigational Site Number 246001
  • Sanofi-Aventis Investigational Site Number 246003
  • Sanofi-Aventis Investigational Site Number 246005
  • Sanofi-Aventis Investigational Site Number 246002
  • Sanofi-Aventis Investigational Site Number 246004
  • Sanofi-Aventis Investigational Site Number 250008
  • Sanofi-Aventis Investigational Site Number 250007
  • Sanofi-Aventis Investigational Site Number 250006
  • Sanofi-Aventis Investigational Site Number 250001
  • Sanofi-Aventis Investigational Site Number 250003
  • Sanofi-Aventis Investigational Site Number 250005
  • Sanofi-Aventis Investigational Site Number 250004
  • Sanofi-Aventis Investigational Site Number 250002
  • Sanofi-Aventis Investigational Site Number 276008
  • Sanofi-Aventis Investigational Site Number 276002
  • Sanofi-Aventis Investigational Site Number 276004
  • Sanofi-Aventis Investigational Site Number 276005
  • Sanofi-Aventis Investigational Site Number 276006
  • Sanofi-Aventis Investigational Site Number 276007
  • Sanofi-Aventis Investigational Site Number 276001
  • Sanofi-Aventis Investigational Site Number 276003
  • Sanofi-Aventis Investigational Site Number 528001
  • Sanofi-Aventis Investigational Site Number 643006
  • Sanofi-Aventis Investigational Site Number 643005
  • Sanofi-Aventis Investigational Site Number 643008
  • Sanofi-Aventis Investigational Site Number 643010
  • Sanofi-Aventis Investigational Site Number 643004
  • Sanofi-Aventis Investigational Site Number 643007
  • Sanofi-Aventis Investigational Site Number 643009
  • Sanofi-Aventis Investigational Site Number 643011
  • Sanofi-Aventis Investigational Site Number 643003
  • Sanofi-Aventis Investigational Site Number 643002
  • Sanofi-Aventis Investigational Site Number 643001
  • Sanofi-Aventis Investigational Site Number 703101
  • Sanofi-Aventis Investigational Site Number 703102
  • Sanofi-Aventis Investigational Site Number 703104
  • Sanofi-Aventis Investigational Site Number 703105
  • Sanofi-Aventis Investigational Site Number 703103
  • Sanofi-Aventis Investigational Site Number 710005
  • Sanofi-Aventis Investigational Site Number 710001
  • Sanofi-Aventis Investigational Site Number 710006
  • Sanofi-Aventis Investigational Site Number 710002
  • Sanofi-Aventis Investigational Site Number 710003
  • Sanofi-Aventis Investigational Site Number 710004
  • Sanofi-Aventis Investigational Site Number 752004
  • Sanofi-Aventis Investigational Site Number 752002
  • Sanofi-Aventis Investigational Site Number 752003
  • Sanofi-Aventis Investigational Site Number 752005
  • Sanofi-Aventis Investigational Site Number 752001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

SSR125543 20 mg

SSR125543 50 mg

SSR125543 100 mg

escitalopram 10 mg

placebo

Arm Description

1 capsule of SSR125543 20 mg + 1 capsule of placebo

1 capsule of SSR125543 50 mg + 1 capsule of placebo

2 capsules of SSR125543 50 mg

1 capsule of escitalopram 10 mg + 1 capsule of placebo

2 capsules of placebo

Outcomes

Primary Outcome Measures

Change from baseline (Day -1) to Day 56 in the 17-item HAM-D total score

Secondary Outcome Measures

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

Full Information

First Posted
December 17, 2009
Last Updated
April 13, 2011
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01034995
Brief Title
A Trial Evaluating the Efficacy and Tolerability of SSR125543 in Outpatients With Major Depressive Disorder
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
580 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SSR125543 20 mg
Arm Type
Experimental
Arm Description
1 capsule of SSR125543 20 mg + 1 capsule of placebo
Arm Title
SSR125543 50 mg
Arm Type
Experimental
Arm Description
1 capsule of SSR125543 50 mg + 1 capsule of placebo
Arm Title
SSR125543 100 mg
Arm Type
Experimental
Arm Description
2 capsules of SSR125543 50 mg
Arm Title
escitalopram 10 mg
Arm Type
Active Comparator
Arm Description
1 capsule of escitalopram 10 mg + 1 capsule of placebo
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
2 capsules of placebo
Intervention Type
Drug
Intervention Name(s)
SSR125543
Intervention Description
Pharmaceutical form: capsule Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
escitalopram
Intervention Description
Pharmaceutical form: encapsulated tablets Route of administration: oral
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Pharmaceutical form: capsule Route of administration: oral
Primary Outcome Measure Information:
Title
Change from baseline (Day -1) to Day 56 in the 17-item HAM-D total score
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in HAM-D depressed mood item
Time Frame
8 weeks
Title
Change from baseline in HAM-D responders (50% improvement)
Time Frame
8 weeks
Title
Changes from baseline in the HAM-D core and factor scores
Time Frame
8 weeks
Title
Changes from baseline in the Montgomery-Asberg depression rating scale (MADRS) total score
Time Frame
8 weeks
Title
Changes from baseline in the Clinical Global Impression (CGI) Severity of Illness score
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Investigational Site Number 056002
City
Asse
ZIP/Postal Code
1730
Country
Belgium
Facility Name
Sanofi-Aventis Investigational Site Number 056003
City
Bruxelles
ZIP/Postal Code
1180
Country
Belgium
Facility Name
Sanofi-Aventis Investigational Site Number 056001
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Sanofi-Aventis Investigational Site Number 124011
City
Burlington
ZIP/Postal Code
L7R 4E2
Country
Canada
Facility Name
Sanofi-Aventis Investigational Site Number 124012
City
Chatham
ZIP/Postal Code
N7M 1B7
Country
Canada
Facility Name
Sanofi-Aventis Investigational Site Number 124004
City
Edmonton
ZIP/Postal Code
T6L 5X8
Country
Canada
Facility Name
Sanofi-Aventis Investigational Site Number 124003
City
Gatineau
ZIP/Postal Code
J9A 1K7
Country
Canada
Facility Name
Sanofi-Aventis Investigational Site Number 124001
City
Kelowna
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
Sanofi-Aventis Investigational Site Number 124006
City
Mississauga
ZIP/Postal Code
L5M 4N4
Country
Canada
Facility Name
Sanofi-Aventis Investigational Site Number 124008
City
Penticton
ZIP/Postal Code
V2A 4M4
Country
Canada
Facility Name
Sanofi-Aventis Investigational Site Number 124007
City
Sherbrooke
ZIP/Postal Code
J1V 4J7
Country
Canada
Facility Name
Sanofi-Aventis Investigational Site Number 124009
City
Toronto
ZIP/Postal Code
M3H 5S4
Country
Canada
Facility Name
Sanofi-Aventis Investigational Site Number 152001
City
Santiago
ZIP/Postal Code
750-0710
Country
Chile
Facility Name
Sanofi-Aventis Investigational Site Number 152002
City
Santiago
ZIP/Postal Code
751-0041
Country
Chile
Facility Name
Sanofi-Aventis Investigational Site Number 152003
City
Santiago
ZIP/Postal Code
756-0356
Country
Chile
Facility Name
Sanofi-Aventis Investigational Site Number 152005
City
Santiago
ZIP/Postal Code
8053095
Country
Chile
Facility Name
Sanofi-Aventis Investigational Site Number 152006
City
Santiago
ZIP/Postal Code
890-0085
Country
Chile
Facility Name
Sanofi-Aventis Investigational Site Number 152004
City
Santiago
Country
Chile
Facility Name
Sanofi-Aventis Investigational Site Number 152007
City
Valparaiso
ZIP/Postal Code
236-0002
Country
Chile
Facility Name
Sanofi-Aventis Investigational Site Number 152008
City
Vina Del Mar
Country
Chile
Facility Name
Sanofi-Aventis Investigational Site Number 233001
City
Tallinn
ZIP/Postal Code
10613
Country
Estonia
Facility Name
Sanofi-Aventis Investigational Site Number 233002
City
Tallinn
ZIP/Postal Code
11911
Country
Estonia
Facility Name
Sanofi-Aventis Investigational Site Number 233004
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Sanofi-Aventis Investigational Site Number 233003
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Sanofi-Aventis Investigational Site Number 246001
City
Helsinki
ZIP/Postal Code
00260
Country
Finland
Facility Name
Sanofi-Aventis Investigational Site Number 246003
City
Helsinki
ZIP/Postal Code
00530
Country
Finland
Facility Name
Sanofi-Aventis Investigational Site Number 246005
City
Järvenpää
ZIP/Postal Code
04400
Country
Finland
Facility Name
Sanofi-Aventis Investigational Site Number 246002
City
Tampere
ZIP/Postal Code
33200
Country
Finland
Facility Name
Sanofi-Aventis Investigational Site Number 246004
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
Sanofi-Aventis Investigational Site Number 250008
City
Arcachon
ZIP/Postal Code
33120
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250007
City
Dole
ZIP/Postal Code
39100
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250006
City
Elancourt
ZIP/Postal Code
78990
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250001
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250003
City
Montpellier Cedex 05
ZIP/Postal Code
34295
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250005
City
Nimes Cedex 9
ZIP/Postal Code
30029
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250004
City
Orvault
ZIP/Postal Code
44700
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 250002
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Sanofi-Aventis Investigational Site Number 276008
City
Achim
ZIP/Postal Code
28832
Country
Germany
Facility Name
Sanofi-Aventis Investigational Site Number 276002
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Sanofi-Aventis Investigational Site Number 276004
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Sanofi-Aventis Investigational Site Number 276005
City
Leipzig
ZIP/Postal Code
04107
Country
Germany
Facility Name
Sanofi-Aventis Investigational Site Number 276006
City
Mannheim
ZIP/Postal Code
68159
Country
Germany
Facility Name
Sanofi-Aventis Investigational Site Number 276007
City
München
ZIP/Postal Code
80333
Country
Germany
Facility Name
Sanofi-Aventis Investigational Site Number 276001
City
Schwerin
ZIP/Postal Code
19053
Country
Germany
Facility Name
Sanofi-Aventis Investigational Site Number 276003
City
Würzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
Sanofi-Aventis Investigational Site Number 528001
City
Den Haag
ZIP/Postal Code
2512 VA
Country
Netherlands
Facility Name
Sanofi-Aventis Investigational Site Number 643006
City
Moscow
ZIP/Postal Code
117152
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 643005
City
Nizhny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 643008
City
Rostov-Na-Donu
ZIP/Postal Code
344010
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 643010
City
Saint-Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 643004
City
Samara
ZIP/Postal Code
443016
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 643007
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 643009
City
St-Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 643011
City
St-Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 643003
City
St-Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 643002
City
St-Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 643001
City
St.-Petersburg
ZIP/Postal Code
190005
Country
Russian Federation
Facility Name
Sanofi-Aventis Investigational Site Number 703101
City
Bratislava 2
ZIP/Postal Code
82606
Country
Slovakia
Facility Name
Sanofi-Aventis Investigational Site Number 703102
City
Bratislava
ZIP/Postal Code
81107
Country
Slovakia
Facility Name
Sanofi-Aventis Investigational Site Number 703104
City
Michalovce
ZIP/Postal Code
07101
Country
Slovakia
Facility Name
Sanofi-Aventis Investigational Site Number 703105
City
Rimavska Sobota
ZIP/Postal Code
979 12
Country
Slovakia
Facility Name
Sanofi-Aventis Investigational Site Number 703103
City
Roznava
ZIP/Postal Code
04801
Country
Slovakia
Facility Name
Sanofi-Aventis Investigational Site Number 710005
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Sanofi-Aventis Investigational Site Number 710001
City
Cape Town
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Sanofi-Aventis Investigational Site Number 710006
City
Centurion
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Sanofi-Aventis Investigational Site Number 710002
City
Durban
ZIP/Postal Code
3629
Country
South Africa
Facility Name
Sanofi-Aventis Investigational Site Number 710003
City
Pretoria
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Sanofi-Aventis Investigational Site Number 710004
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Sanofi-Aventis Investigational Site Number 752004
City
Linköping
ZIP/Postal Code
582 16
Country
Sweden
Facility Name
Sanofi-Aventis Investigational Site Number 752002
City
Lund
ZIP/Postal Code
223 61
Country
Sweden
Facility Name
Sanofi-Aventis Investigational Site Number 752003
City
Malmö
ZIP/Postal Code
211 52
Country
Sweden
Facility Name
Sanofi-Aventis Investigational Site Number 752005
City
Stockholm
ZIP/Postal Code
112 34
Country
Sweden
Facility Name
Sanofi-Aventis Investigational Site Number 752001
City
Uppsala
ZIP/Postal Code
753 10
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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