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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00825019
First received: January 16, 2009
Last updated: March 24, 2009
Last verified: March 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Depression
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HAM-D subscores, HAMD responders and remitters, HAM-A total score and subscores [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Montgomery-Asberg Depression Rating Scale (MADRS) total score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • clinical global impression (CGI) severity and improvement scores [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • patient global impression (PGI) improvement score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • social and occupational functioning assessment scale (SOFAS) score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • AEs, Arizona Sexual Experience Scale (ASEX), [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • laboratory parameters, physical examination findings, ECG parameters, change of vital signs, body weight [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

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
paroxetine
 Drug: paroxetine
oral administration of 20 mg/day

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825019

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

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00825019     History of Changes
Other Study ID Numbers: EFC5379
Study First Received: January 16, 2009
Last Updated: March 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Paroxetine
SR 58611A
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on May 19, 2013