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OpenTrials
Completed

NCT Number: NCT00385307

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

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

amibegron (SR58611A)

Drug

Primary outcomes

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

Secondary outcomes

  1. Safety assessments

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 9, 2006
Registry last updated
Mar 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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