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CompletedNCT00385307Updated Mar 25, 2009

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

A Phase 3 interventional study of amibegron (SR58611A) in Major Depressive Disorder, sponsored by Sanofi. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-03-25.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
680
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Major Depressive Disorder

Keywords

  • Depression
  • Clinical Trials
  • Major Depressive Disorder
03

In context

Depressive Disorder, Major

2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.

This study's enrollment of 680 is above the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
680 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Safety assessments

07

Study locations

1 site
  • Sanofi-Aventis Administrative Office
    Bridgewater, New Jersey 08807, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2006, a primary completion of Nov 2007 and a completion of Nov 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2006
First posted
Oct 9, 2006
Start
Sep 2006
Primary completionActual
Nov 2007
CompletionActual
Nov 2007
Last update
Mar 25, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 25, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00385307
Lead sponsor
Sanofi
First posted
Oct 9, 2006
Start date
Sep 2006
Primary completion
Nov 2007
Completion
Nov 2007
Last update
Mar 25, 2009

Study contacts

ICD CSD
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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