An Eight-week Study of Saredutant and Escitalopram as Combination Treatment for Major Depressive Disorder

Study Overview
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Brief Summary
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The main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in combination with escitalopram 10mg once daily compared to saredutant placebo in combination with escitalopram 10mg once daily in patients with major depressive disorder. This study also includes a double-placebo group (saredutant placebo in combination with escitalopram placebo).

Official Title
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An Eight-week, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Saredutant 100 mg Once Daily in Combination With Escitalopram 10 mg Once Daily in Patients With Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: saredutant (SR48968)
* Drug: escitalopram
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients with recurrent Major Depressive Disorder Exclusion Criteria: Symptoms of current depressive episode for less than 30 days or more than 2 years Mild depression, as measured by standard clinical research scales Significant suicide risk Lack of sexual activity (including masturbation) Other psychiatric conditions that would obscure the results of the study History of failure to respond to antidepressant treatment Pregnancy or breast-feeding 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: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Saredudant/Escitalopram<br>Saredutant 100 mg and Escitalopram 10 mg once daily for a maximum of 8 weeks | Drug: saredutant (SR48968)<br>* oral administration, capsules<br>Drug: escitalopram<br>* oral administration, capsules<br>|
| Active Comparator: Placebo and Escitalopram<br>Placebo for saredutant and Escitalopram 10 mg once daily for a maximum of 8 weeks | Drug: escitalopram<br>* oral administration, capsules<br>Drug: placebo<br>* oral administration, capsules<br>|
| Placebo Comparator: Placebo<br>Placebo for saredutant and Placebo for Escitalopram once daily for one week during the screening phase and for a maximum of 8 weeks during the active phase | Drug: placebo<br>* oral administration, capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Day 56 in Hamilton depression rating scale (HAM-D) total score |  | Baseline, Day 56 | 
| Change from Baseline to Day 56 in the CGI-S Severity of Illness score |  | Baseline, Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Day 56 in the Clinical Global Impression (CGI) severity of illness score |  | Baseline, Day 56 | 
| Change from baseline to Day 56 in HAM-D depressed mood item scores. |  | Baseline, Day 56 | 
| Percentage of patients demonstrating a treatment response | response is defined as a reduction of at least 50% in HAM-D total score between baseline and any post-baseline assessment | Day 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Major Depressive Episode, Antidepressant