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

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Sanofi

Status and phase

Completed
Phase 2

Conditions

Major Depression

Treatments

Drug: placebo
Drug: escitalopram
Drug: SSR125543

Study type

Interventional

Funder types

Industry

Identifiers

NCT01034995
DFI5687
2009-010339-42 (Other Identifier)

Details and patient eligibility

About

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

Full description

This duration of this trial is 11 weeks.

Enrollment

580 estimated patients

Sex

All

Ages

18 to 64 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

580 participants in 5 patient groups, including a placebo group

SSR125543 20 mg
Experimental group
Description:
1 capsule of SSR125543 20 mg + 1 capsule of placebo
Treatment:
Drug: SSR125543
SSR125543 50 mg
Experimental group
Description:
1 capsule of SSR125543 50 mg + 1 capsule of placebo
Treatment:
Drug: SSR125543
SSR125543 100 mg
Experimental group
Description:
2 capsules of SSR125543 50 mg
Treatment:
Drug: SSR125543
escitalopram 10 mg
Active Comparator group
Description:
1 capsule of escitalopram 10 mg + 1 capsule of placebo
Treatment:
Drug: escitalopram
placebo
Placebo Comparator group
Description:
2 capsules of placebo
Treatment:
Drug: placebo

Trial contacts and locations

73

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Data sourced from clinicaltrials.gov

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