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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01034995

Acronym

AGATE

Enrollment

580

Registered

2009-12-18

Start date

2010-02-28

Completion date

2011-03-31

Last updated

2011-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depression

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.

Interventions

DRUGSSR125543

Pharmaceutical form: capsule Route of administration: oral

DRUGescitalopram

Pharmaceutical form: encapsulated tablets Route of administration: oral

DRUGplacebo

Pharmaceutical form: capsule Route of administration: oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline (Day -1) to Day 56 in the 17-item HAM-D total score	8 weeks

Secondary

Measure	Time frame
Change from baseline in HAM-D depressed mood item	8 weeks
Change from baseline in HAM-D responders (50% improvement)	8 weeks
Changes from baseline in the HAM-D core and factor scores	8 weeks
Changes from baseline in the Montgomery-Asberg depression rating scale (MADRS) total score	8 weeks
Changes from baseline in the Clinical Global Impression (CGI) Severity of Illness score	8 weeks

Countries

Belgium, Canada, Chile, Estonia, Finland, France, Germany, Netherlands, Russia, Slovakia, South Africa, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026