Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (SIRIUS)
NCT ID: NCT00385307
Last Updated: 2009-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
680 participants
INTERVENTIONAL
2006-09-30
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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amibegron (SR58611A)
Eligibility Criteria
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Inclusion Criteria
* Patient meets criteria for a recurrent Major Depressive Episode (MDE)
* Patient meets severity assessments of depression specified by the study
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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ICD CSD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Countries
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Other Identifiers
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EFC6607
Identifier Type: -
Identifier Source: org_study_id
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