Efficacy and Safety of One Single Dose of SR58611 Compared to Placebo and Paroxetine

Study Overview
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Brief Summary
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Primary objective is to demonstrate the antidepressant efficacy on the Hamilton depression rating scale (HAM-D) of amibegron (SR58611) 700 mg/day compared to placebo in the treatment of patients with a recurrent major depressive episode (MDD). Secondary objective is to assess the safety profile of amibegron 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.

Official Title
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A Double-Blind, Multicenter Study Evaluating the Efficacy and Safety of One Fixed Dose of SR58611A (700 mg/Day) Versus Placebo and Paroxetine (20 mg/Day) in Patients With a Recurrent Major Depressive Episode.

Conditions
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Major Depressive Disorders

Intervention / Treatment
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* Drug: amibegron (SR58611A)
* Drug: placebo
* Drug: paroxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients suffering from a recurrent major depressive episode of at least moderate intensity (DSM-IV) patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months. the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration.

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: 1<br> | Drug: amibegron (SR58611A)<br>* oral administration of 2x 700 mg/day in 12h intervals<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* oral administration in 12h intervals<br>|
| Active Comparator: 3<br>paroxetine | Drug: paroxetine<br>* oral administration of 20 mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline of the total score of the HAM-D 17 items |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAM-D subscores, HAMD responders and remitters, HAM-A total score and subscores |  | 6 weeks | 
| Montgomery-Asberg Depression Rating Scale (MADRS) total score |  | 6 weeks | 
| clinical global impression (CGI) severity and improvement scores |  | 6 weeks | 
| patient global impression (PGI) improvement score |  | 6 weeks | 
| social and occupational functioning assessment scale (SOFAS) score |  | 6 weeks | 
| AEs, Arizona Sexual Experience Scale (ASEX), |  | 6 weeks | 
| laboratory parameters, physical examination findings, ECG parameters, change of vital signs, body weight |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression