Efficacy and Safety of SR58611A co-Administered With Escitalopram in Adults With Major Depressive Disorder

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: SR58611A; Drug: placebo; Drug: escitalopram

• Registration Number: NCT00432614
• Lead Sponsor: Sanofi

Brief Summary

The primary objective of the study is to compare, after 8 weeks, the efficacy of SR58611A vs. placebo in patients with Major Depressive Disorder who are on concomitant treatment with escitalopram.

The secondary objective of this study is to document clinical safety and tolerability of SR58611A in association with escitalopram.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-02-07
• Study First Submitted QC: 2007-02-07
• Study First Posted: 2007-02-08
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-24
• Last Update Posted: 2009-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 510

Inclusion Criteria

• Inpatients or outpatients with Major Depressive Disorder characterized by a recurrent Major Depressive Episode with Montgomery and Asberg Depression Rating Scale (MADRS) total score => 30

Exclusion Criteria

• Patient is at immediate risk for suicidal behavior
• Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
• Patients with a current depressive episode secondary to a general medical disorder
• Patients with a lifetime history or presence of bipolar disorder, psychotic disorder, panic disorder and antisocial personality disorder
• Patients with severe or unstable concomitant medical conditions
• Pregnant, breastfeeding, or likely to become pregnant during the study
• Treated with escitalopram within 6 months before the study, or who have had an adverse reaction to escitalopram

The investigator will evaluate whether there are other reasons why a patient may not participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	SR58611A	SR58611A 350mg twice daily with escitalopram 10mg once daily
Group 3	placebo	placebo
Group 1	escitalopram	SR58611A 350mg twice daily with escitalopram 10mg once daily
Group 2	escitalopram	placebo with escitalopram 10mg once daily

Primary Outcome Measures

Name	Time	Method
Change from baseline in Hamilton Depression Rating scale (HAM-D) total score	8 weeks

Secondary Outcome Measures

Name	Time	Method
Speed of response based on HAM-D and change in Clinical Global Impression (CGI) severity score	8 weeks

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇹🇷 Istanbul, Turkey