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

• ClinicalTrials.gov Identifier: NCT00385307
• Recruitment Status: Completed
• First Posted: October 9, 2006
• Last Update Posted: March 25, 2009
• Sponsor: Sanofi
• Information provided by: Sanofi

Tracking Information

• First Submitted Date: October 6, 2006
• First Posted Date: October 9, 2006
• Last Update Posted Date: March 25, 2009
• Study Start Date: September 2006
• Actual Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 6, 2006): Change from baseline in total score of a depression rating scale at 8 weeks
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: October 6, 2006): Safety assessments
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS)
• 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
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Major Depressive Disorder
• Intervention: Drug: amibegron (SR58611A)
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 13, 2008): 680
• Original Enrollment (submitted: October 6, 2006): 660
• Actual Study Completion Date: November 2007
• Actual Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00385307
• Other Study ID Numbers: EFC6607
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: ICD Study Director, sanofi-aventis
• Original Responsible Party: Not Provided
• Current Study Sponsor: Sanofi
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: ICD CSD; Sanofi

• PRS Account: Sanofi
• Verification Date: March 2009