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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Major Depression

Treatments: Drug: placebo; Drug: SSR125543; Drug: escitalopram

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

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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