This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Efficacy and Safety of One Single Dose of SR58611 Compared to Placebo and Paroxetine

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: January 16, 2009
Last updated: March 24, 2009
Last verified: March 2009

Primary objective is to demonstrate the antidepressant efficacy on the Hamilton depression rating scale (HAM-D) of amibegron (SR58611) 700 mg/day compared to placebo in the treatment of patients with a recurrent major depressive episode (MDD).

Secondary objective is to assess the safety profile of amibegron 700 mg/d in comparison to placebo and to assess plasma concentrations of the active metabolite.

Condition Intervention Phase
Major Depressive Disorders Drug: amibegron (SR58611A) Drug: placebo Drug: paroxetine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • change from baseline of the total score of the HAM-D 17 items [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • HAM-D subscores, HAMD responders and remitters, HAM-A total score and subscores [ Time Frame: 6 weeks ]
  • Montgomery-Asberg Depression Rating Scale (MADRS) total score [ Time Frame: 6 weeks ]
  • clinical global impression (CGI) severity and improvement scores [ Time Frame: 6 weeks ]
  • patient global impression (PGI) improvement score [ Time Frame: 6 weeks ]
  • social and occupational functioning assessment scale (SOFAS) score [ Time Frame: 6 weeks ]
  • AEs, Arizona Sexual Experience Scale (ASEX), [ Time Frame: 6 weeks ]
  • laboratory parameters, physical examination findings, ECG parameters, change of vital signs, body weight [ Time Frame: 6 weeks ]

Enrollment: 306
Study Start Date: September 2003
Study Completion Date: December 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: amibegron (SR58611A)
oral administration of 2x 700 mg/day in 12h intervals
Placebo Comparator: 2 Drug: placebo
oral administration in 12h intervals
Active Comparator: 3
Drug: paroxetine
oral administration of 20 mg/day


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00825019

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

Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00825019     History of Changes
Other Study ID Numbers: EFC5379
Study First Received: January 16, 2009
Last Updated: March 24, 2009

Keywords provided by Sanofi:

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents processed this record on August 16, 2017