Efficacy and Safety of SR58611A co-Administered With Escitalopram in Adults With Major Depressive Disorder

Study Overview
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Brief Summary
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The primary objective of the study is to compare, after 8 weeks, the efficacy of SR58611A vs. placebo in patients with Major Depressive Disorder who are on concomitant treatment with escitalopram. The secondary objective of this study is to document clinical safety and tolerability of SR58611A in association with escitalopram.

Official Title
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A Multi-National, Multi-Center, DB, Placebo-Controlled, Parallel Group, Fixed Dose Efficacy & Safety Study of SR58611A 350 mg Twice Daily vs. Placebo in Adults With Major Depressive Disorder on Concomitant Treatment With Escitalopram 10mg/d

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: SR58611A
* Drug: escitalopram
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatients or outpatients with Major Depressive Disorder characterized by a recurrent Major Depressive Episode with Montgomery and Asberg Depression Rating Scale (MADRS) total score => 30 Exclusion Criteria: Patient is at immediate risk for suicidal behavior Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset Patients with a current depressive episode secondary to a general medical disorder Patients with a lifetime history or presence of bipolar disorder, psychotic disorder, panic disorder and antisocial personality disorder Patients with severe or unstable concomitant medical conditions Pregnant, breastfeeding, or likely to become pregnant during the study Treated with escitalopram within 6 months before the study, or who have had an adverse reaction to escitalopram The investigator will evaluate whether there are other reasons why a patient may not participate.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>SR58611A 350mg twice daily with escitalopram 10mg once daily | Drug: SR58611A<br>* oral administration<br>Drug: escitalopram<br>* oral administration<br>|
| Active Comparator: Group 2<br>placebo with escitalopram 10mg once daily | Drug: escitalopram<br>* oral administration<br>|
| Placebo Comparator: Group 3<br>placebo | Drug: placebo<br>* oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Hamilton Depression Rating scale (HAM-D) total score |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed of response based on HAM-D and change in Clinical Global Impression (CGI) severity score |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mental Disorder, Mood Disorder, Depressive Disorder