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

December 17, 2009
April 13, 2011
February 2010
March 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01034995 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Trial Evaluating the Efficacy and Tolerability of SSR125543 in Outpatients With Major Depressive Disorder
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

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

This duration of this trial is 11 weeks.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depression
  • Drug: SSR125543

    Pharmaceutical form: capsule

    Route of administration: oral

  • Drug: escitalopram

    Pharmaceutical form: encapsulated tablets

    Route of administration: oral

  • Drug: placebo

    Pharmaceutical form: capsule

    Route of administration: oral

  • Experimental: SSR125543 20 mg
    1 capsule of SSR125543 20 mg + 1 capsule of placebo
    Intervention: Drug: SSR125543
  • Experimental: SSR125543 50 mg
    1 capsule of SSR125543 50 mg + 1 capsule of placebo
    Intervention: Drug: SSR125543
  • Experimental: SSR125543 100 mg
    2 capsules of SSR125543 50 mg
    Intervention: Drug: SSR125543
  • Active Comparator: escitalopram 10 mg
    1 capsule of escitalopram 10 mg + 1 capsule of placebo
    Intervention: Drug: escitalopram
  • Placebo Comparator: placebo
    2 capsules of placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
580
March 2011
March 2011   (final data collection date for primary outcome measure)

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.

Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Chile,   Estonia,   Finland,   France,   Germany,   Netherlands,   Russian Federation,   Slovakia,   South Africa,   Sweden
 
NCT01034995
DFI5687, 2009-010339-42
Yes
Trial Transparency Team, sanofi-aventis
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP