- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00385307
Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS)
March 24, 2009 updated by: Sanofi
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
680
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Bridgewater, New Jersey, United States, 08807
- Sanofi-Aventis Administrative Office
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Change from baseline in total score of a depression rating scale at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
---|
Safety assessments
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
October 6, 2006
First Submitted That Met QC Criteria
October 6, 2006
First Posted (Estimate)
October 9, 2006
Study Record Updates
Last Update Posted (Estimate)
March 25, 2009
Last Update Submitted That Met QC Criteria
March 24, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFC6607
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depressive Disorder
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Fondo de Investigacion SanitariaUnknown
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
AccexibleRecruitingMajor Depressive Disorder (MDD)Spain
Clinical Trials on amibegron (SR58611A)
-
SanofiCompletedMajor Depressive DisordersRussian Federation, Spain, Singapore, Taiwan, Tunisia, Argentina, Chile, Hong Kong, Morocco, South Africa, Greece
-
SanofiCompletedDepressive DisorderRomania, Bulgaria, Serbia, Slovakia, Finland
-
SanofiTerminatedAnxiety DisordersFrance, Russian Federation, Australia, Germany, Spain, Mexico, Hungary, Italy, Chile
-
SanofiCompletedAnxiety DisorderUnited States
-
SanofiCompletedDepressive Disorder | Major DepressionFrance, Poland, Romania, Russian Federation, Bulgaria, Serbia, Slovakia, Czech Republic, Mexico, Argentina, Croatia, Finland, South Africa
-
SanofiCompletedMajor Depressive DisorderUnited States, Canada
-
SanofiCompletedMajor Depressive DisorderUnited States, Canada
-
SanofiTerminatedAnxiety DisordersRomania, Slovakia, Croatia, Austria, Finland
-
SanofiCompletedAnxiety DisordersFrance, Russian Federation, Sweden, Estonia, Argentina, Austria, South Africa
-
SanofiCompletedAnxiety DisordersPoland, Bulgaria, Serbia, Czech Republic, Croatia