ClinicalTrials.gg
Sign In
CompletedNCT00825058Updated Mar 25, 2009

Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine

A Phase 3 interventional study of amibegron (SR58611A) and placebo in Major Depressive Disorders, sponsored by Sanofi. Completed at 8 sites in 8 countries. 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
317
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Primary objective :

  • To demonstrate the antidepressant efficacy on the Hamilton Depression Rating Scale of SR58611A 700mg/day compared with placebo in the treatment of patients with a recurrent major depressive episode.

Secondary objectives:

  • To assess the safety profile of SR58611A 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.
02

Conditions studied

  • Major Depressive Disorders

Keywords

  • Depression
03

In context

Depressive Disorder, Major

3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.

This study's enrollment of 317 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.

Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.

Browse Sanofi studies →

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

Eligibility criteria

Inclusion Criteria:

  • patients suffering from a recurrent major depressive episode of at least moderate intensity ()
  • patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months.
  • the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

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

Study arms

  • Experimental
    1

    Drug: amibegron (SR58611A)

  • Placebo comparator
    2

    Drug: placebo

  • Active comparator
    3

    Drug: paroxetine

Interventions

  • Drugamibegron (SR58611A)

    oral administration 2 X 350mg/day at 12 hours intervals

  • Drugplacebo

    oral administration 12 hours intervals

  • Drugparoxetine

    oral 20 mg/day

06

What researchers measure

Primary outcomes

  1. change from baseline of the total score of the HAM-D 17 items.

    Time frame: 6 weeks

Secondary outcomes

  1. HAM-D subscores

    Time frame: 6 weeks

  2. HAM-D responders and remitters

    Time frame: 6 weeks

  3. HAM-A total score and subscores

    Time frame: 6 weeks

  4. MADRS total score

    Time frame: 6 weeks

  5. clinical global impression (CGI) severity and improvement scores

    Time frame: 6 weeks

  6. patient global impression (PGI) improvement score

    Time frame: 6 weeks

  7. social and occupational functioning assessment scale (SOFAS) score

    Time frame: 6 weeks

  8. clinical monitoring of adverse events (AEs)

    Time frame: 6 weeks

  9. laboratory parameters

    Time frame: 6 weeks

  10. electrocardiogram (ECG) parameters, change in vital signs and body weight

    Time frame: 6 weeks

07

Study locations

8 sites
  • Sanofi-Aventis Administrative Office
    Sofia, Bulgaria
  • Sanofi-Aventis Administrative Office
    Zagreb, Croatia
  • Sanofi-Aventis Administrative Office
    Praha, Czech Republic
  • Sanofi-Aventis Administrative Office
    Tallinn, Estonia
  • Sanofi-Aventis Administrative Office
    Paris, France
  • Sanofi-Aventis Administrative Office
    Montenegro, Montenegro
  • Sanofi-Aventis Administrative Office
    Gouda, Netherlands
  • Sanofi-Aventis Administrative Office
    Belgrade, Serbia
08

Timeline

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

The record gives a start of Nov 2003, a primary completion of May 2004 and a completion of Oct 2004. 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
Jan 16, 2009
First posted
Jan 19, 2009
Start
Nov 2003
Primary completionActual
May 2004
CompletionActual
Oct 2004
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
NCT00825058
Lead sponsor
Sanofi
First posted
Jan 19, 2009
Start date
Nov 2003
Primary completion
May 2004
Completion
Oct 2004
Last update
Mar 25, 2009

Study contacts

ICD CSD
study director · Sanofi

Oversight

Data monitoring committee
No
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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Amibegron

Other studies in this condition

Depressive Disorder, Major →

Other studies from this sponsor

Sanofi →

Start the discussion