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

Study Overview
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Brief Summary
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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
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This duration of this trial is 11 weeks.

Official Title
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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

Conditions
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Major Depression

Intervention / Treatment
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* Drug: SSR125543
* Drug: escitalopram
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SSR125543 20 mg<br>1 capsule of SSR125543 20 mg + 1 capsule of placebo | Drug: SSR125543<br>* Pharmaceutical form: capsule Route of administration: oral<br>|
| Experimental: SSR125543 50 mg<br>1 capsule of SSR125543 50 mg + 1 capsule of placebo | Drug: SSR125543<br>* Pharmaceutical form: capsule Route of administration: oral<br>|
| Experimental: SSR125543 100 mg<br>2 capsules of SSR125543 50 mg | Drug: SSR125543<br>* Pharmaceutical form: capsule Route of administration: oral<br>|
| Active Comparator: escitalopram 10 mg<br>1 capsule of escitalopram 10 mg + 1 capsule of placebo | Drug: escitalopram<br>* Pharmaceutical form: encapsulated tablets Route of administration: oral<br>|
| Placebo Comparator: placebo<br>2 capsules of placebo | Drug: placebo<br>* Pharmaceutical form: capsule Route of administration: oral<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |