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OpenTrials
Completed

NCT Number: NCT00825058

Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine

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.

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Key information

Conditions

Major Depressive Disorders 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, Sofia, Bulgaria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients suffering from a recurrent major depressive episode of at least moderate intensity (DSM-IV)
  • 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

Treatment and study plan

amibegron (SR58611A)

Drug

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

Placebo

Drug

oral administration 12 hours intervals

paroxetine

Drug

oral 20 mg/day

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Double-Blind, Multicenter Study Evaluating the Efficacy and Safety of One Fixed Dose of SR58611A (700 mg/Day) Versus Placebo and Paroxetine (20 mg/Day) in Patients With a Recurrent Major Depressive Episode.

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Jan 19, 2009
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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