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

Phase 3

Completed

• Conditions: Depressive Disorder, Major
• Interventions: Drug: saredutant (SR48968); Drug: placebo; Drug: paroxetine

• Registration Number: NCT00629551
• Lead Sponsor: Sanofi

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-26
• Study First Submitted QC: 2008-03-05
• Study First Posted: 2008-03-06
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2016-04
• Disposition First Submitted: 2016-04-26
• Disposition First Submitted QC: 2016-04-26
• Last Update Submitted: 2016-04-26
• Disposition First Posted: 2016-05-26
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 825

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saredutant 30mg and Paroxetine 20mg	saredutant (SR48968)	combined saredutant 30mg and paroxetine 20mg once daily for a maximum of 8 weeks
Saredutant 100mg and Paroxetine 20 mg	saredutant (SR48968)	combined saredutant 100mg and paroxetine 20mg once daily for a maximum of 8 weeks
Paroxetine 20 mg and saredutant placebo	placebo	paroxetine 20mg and saredutant placebo once daily for a maximum of 8 weeks
Placebo	placebo	Saredutant placebo and paroxetine placebo once daily for one week during screening period and maximum of 8 weeks for the active phase
Saredutant 100mg and Paroxetine 20 mg	paroxetine	combined saredutant 100mg and paroxetine 20mg once daily for a maximum of 8 weeks
Saredutant 30mg and Paroxetine 20mg	paroxetine	combined saredutant 30mg and paroxetine 20mg once daily for a maximum of 8 weeks
Paroxetine 20 mg and saredutant placebo	paroxetine	paroxetine 20mg and saredutant placebo once daily for a maximum of 8 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇿🇦 Midrand, South Africa