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

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

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: amibegron (SR58611A) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : September 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Change from baseline in total score of a depression rating scale at 8 weeks

Secondary Outcome Measures :
  1. Safety assessments


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385307


Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00385307     History of Changes
Other Study ID Numbers: EFC6607
First Posted: October 9, 2006    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by Sanofi:
Depression
Clinical Trials
Major Depressive Disorder

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Amibegron
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs