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

Phase 3

Completed

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

• Registration Number: NCT00531622
• Lead Sponsor: Sanofi

Brief Summary

The main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in combination with escitalopram 10mg once daily compared to saredutant placebo in combination with escitalopram 10mg once daily in patients with major depressive disorder. This study also includes a double-placebo group (saredutant placebo in combination with escitalopram placebo).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-18
• Study First Submitted QC: 2007-09-18
• Study First Posted: 2007-09-19
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2016-04
• Disposition First Submitted: 2016-04-25
• Disposition First Submitted QC: 2016-04-25
• Last Update Submitted: 2016-04-25
• Disposition First Posted: 2016-05-24
• Last Update Posted: 2016-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 643

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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saredudant/Escitalopram	saredutant (SR48968)	Saredutant 100 mg and Escitalopram 10 mg once daily for a maximum of 8 weeks
Saredudant/Escitalopram	escitalopram	Saredutant 100 mg and Escitalopram 10 mg once daily for a maximum of 8 weeks
Placebo and Escitalopram	escitalopram	Placebo for saredutant and Escitalopram 10 mg once daily for a maximum of 8 weeks
Placebo and Escitalopram	placebo	Placebo for saredutant and Escitalopram 10 mg once daily for a maximum of 8 weeks
Placebo	placebo	Placebo for saredutant and Placebo for Escitalopram once daily for one week during the screening phase and for a maximum of 8 weeks during the active phase

Primary Outcome Measures

Name	Time	Method
Change from baseline to Day 56 in Hamilton depression rating scale (HAM-D) total score	Baseline, Day 56
Change from Baseline to Day 56 in the CGI-S Severity of Illness score	Baseline, Day 56

Secondary Outcome Measures

Name	Time	Method
Change from baseline to Day 56 in the Clinical Global Impression (CGI) severity of illness score	Baseline, Day 56
Change from baseline to Day 56 in HAM-D depressed mood item scores.	Baseline, Day 56
Percentage of patients demonstrating a treatment response	Day 56	response is defined as a reduction of at least 50% in HAM-D total score between baseline and any post-baseline assessment

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇸🇪 Bromma, Sweden