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

Sanofi825 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

825

Conditions

Depressive Disorder, Major

Interventions

saredutant (SR48968)DRUG

oral administration,capsules

paroxetineDRUG

oral administration, capsules

placeboDRUG

oral administration, capsules

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (8)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Santiago, Chile

Sanofi-Aventis Administrative Office

Tallinn, Estonia

Sanofi-Aventis Administrative Office

Berlin, Germany

Outcomes

Primary Outcomes

Change from baseline in the Hamilton Depression Rating Scale (HAM-D) total score

Time frame: 8 weeks

Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ) total score

Time frame: weeks

Secondary Outcomes

Change from baseline in the Clinical Global Impression severity of illness score

Time frame: 8 weeks

Change from baseline in the HAM-D depressed mood item scores

Time frame: 8 weeks

Data from ClinicalTrials.gov

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