An Eight-week Study of Saredutant and Paroxetine 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 or 30mg once daily in combination with paroxetine 20mg once daily compared to saredutant placebo in combination with paroxetine 20mg once daily in patients with major depressive disorder. The study also includes a double-placebo group (saredutant placebo in combination with paroxetine placebo).

Official Title
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An Eight-week, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Saredutant (100 mg and 30 mg) Once Daily in Combination With Paroxetine 20 mg Once Daily Compared to Saredutant Placebo in Combination With Paroxetine 20 mg Once Daily in Patients With Major Depressive Disorder

Conditions
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Depressive Disorder, Major

Intervention / Treatment
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* Drug: saredutant (SR48968)
* Drug: paroxetine
* 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

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: Saredutant 100mg and Paroxetine 20 mg<br>combined saredutant 100mg and paroxetine 20mg once daily for a maximum of 8 weeks | Drug: saredutant (SR48968)<br>* oral administration,capsules<br>Drug: paroxetine<br>* oral administration, capsules<br>|
| Experimental: Saredutant 30mg and Paroxetine 20mg<br>combined saredutant 30mg and paroxetine 20mg once daily for a maximum of 8 weeks | Drug: saredutant (SR48968)<br>* oral administration,capsules<br>Drug: paroxetine<br>* oral administration, capsules<br>|
| Active Comparator: Paroxetine 20 mg and saredutant placebo<br>paroxetine 20mg and saredutant placebo once daily for a maximum of 8 weeks | Drug: paroxetine<br>* oral administration, capsules<br>Drug: placebo<br>* oral administration, capsules<br>|
| Placebo Comparator: Placebo<br>Saredutant placebo and paroxetine placebo once daily for one week during screening period and maximum of 8 weeks for 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 in the Hamilton Depression Rating Scale (HAM-D) total score |  | 8 weeks | 
| Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ) total score |  | weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Clinical Global Impression severity of illness score |  | 8 weeks | 
| Change from baseline in the HAM-D depressed mood item scores |  | 8 weeks | 

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