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Completed

NCT Number: NCT01034995

A Trial Evaluating the Efficacy and Tolerability of SSR125543 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

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Key information

Conditions

Major Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Investigational Site Number 056002, Asse, Belgium

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About this study

This duration of this trial is 11 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SSR125543

Drug

Pharmaceutical form: capsule

Route of administration: oral

Escitalopram

Drug

Pharmaceutical form: encapsulated tablets

Route of administration: oral

Placebo

Drug

Pharmaceutical form: capsule

Route of administration: oral

Primary outcomes

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

    Time frame: 8 weeks

Secondary outcomes

  1. Change from baseline in HAM-D depressed mood item

    Time frame: 8 weeks

  2. Change from baseline in HAM-D responders (50% improvement)

    Time frame: 8 weeks

  3. Changes from baseline in the HAM-D core and factor scores

    Time frame: 8 weeks

  4. Changes from baseline in the Montgomery-Asberg depression rating scale (MADRS) total score

    Time frame: 8 weeks

  5. Changes from baseline in the Clinical Global Impression (CGI) Severity of Illness score

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: AGATE

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 18, 2009
Registry last updated
Apr 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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