Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS)

Major Depressive Disorder Clinical Trial

Official title:

An Eight-Week, Double-Blind, Placebo-Controlled, Multicenter Study With Paroxetine (10 mg qd) as Positive Control, Evaluating the Efficacy, Safety, Tolerability of Two Fixed Doses of SR58611A (175 mg q12/ 350 mg q12) in Outpatients With MDD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00385307
• Other study ID #: EFC6607
• Status: Completed
• Phase: Phase 3
• First received: October 6, 2006
• Last updated: March 24, 2009
• Start date: September 2006
• Est. completion date: November 2007

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient with Major Depressive Disorder diagnosed according to Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR

• Patient meets criteria for a recurrent Major Depressive Episode (MDE)

• Patient meets severity assessments of depression specified by the study

Exclusion Criteria:

• Patient is at immediate risk for suicidal behavior

• Patient is with a unstable medical condition

• Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset

• Patient has taken concomitant treatment that may interfere with valid collection or interpretation of study data

• Patient has been treated with non-pharmacologic therapy intended to treat depression in the past 6 months

• Patient has been treated with paroxetine (Paxil) within the previous 6 months

• Patient is pregnant or breastfeeding, or likely to become pregnant during the course of the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• amibegron (SR58611A)

Locations

Country	Name	City	State
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in total score of a depression rating scale at 8 weeks
Secondary	Safety assessments