Back to resultsEfficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS)
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
amibegron (SR58611A)
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Clinical Trials, Major Depressive Disorder
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
Sites / Locations
- Sanofi-Aventis Administrative Office
Outcomes
Primary Outcome Measures
Change from baseline in total score of a depression rating scale at 8 weeks
Secondary Outcome Measures
Safety assessments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00385307
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, Clinical Trials, Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
680 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
amibegron (SR58611A)
Primary Outcome Measure Information:
Title
Change from baseline in total score of a depression rating scale at 8 weeks
Secondary Outcome Measure Information:
Title
Safety assessments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS)
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