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History of Changes for Study: NCT00385307
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS)
Latest version (submitted March 24, 2009) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 6, 2006 None (earliest Version on record)
2 April 2, 2007 Study Status
3 October 1, 2007 Recruitment Status, Study Status, Contacts/Locations and Study Design
4 February 14, 2008 Recruitment Status, Study Status and Sponsor/Collaborators
5 September 12, 2008 Study Status, Study Design, Contacts/Locations and Study Identification
6 November 13, 2008 Study Design, Study Status and Contacts/Locations
7 March 24, 2009 Study Status, References and Arms and Interventions
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Study NCT00385307
Submitted Date:  October 6, 2006 (v1)

Open or close this module Study Identification
Unique Protocol ID: EFC6607
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
Secondary IDs: SR58611
Open or close this module Study Status
Record Verification: October 2006
Overall Status: Recruiting
Study Start: September 2006
Primary Completion:
Study Completion:
First Submitted: October 6, 2006
First Submitted that
Met QC Criteria:
October 6, 2006
First Posted: October 9, 2006 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 6, 2006
Last Update Posted: October 9, 2006 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Sanofi
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Major Depressive Disorder
Keywords: Depression
Clinical Trials
Major Depressive Disorder
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 660
Open or close this module Arms and Interventions
Intervention Details:
Drug: SR58611A
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change from baseline in total score of a depression rating scale at 8 weeks
Secondary Outcome Measures:
1. Safety assessments
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Public Registry ICD
Email: GV-Contact-us@sanofi-aventis.com
Locations: United States, New Jersey
Sanofi-Aventis
[Recruiting]
Bridgewater, New Jersey, United States, 08807
Contact:Contact: GV-Contact-us@sanofi-aventis.com
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: Related Info
Available IPD/Information:

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