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Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00825058
Recruitment Status : Completed
First Posted : January 19, 2009
Last Update Posted : March 25, 2009
Sponsor:
Information provided by:
Sanofi

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorders Drug: amibegron (SR58611A) Drug: placebo Drug: paroxetine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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.
Study Start Date : November 2003
Actual Primary Completion Date : May 2004
Actual Study Completion Date : October 2004


Arm Intervention/treatment
Experimental: 1 Drug: amibegron (SR58611A)
oral administration 2 X 350mg/day at 12 hours intervals

Placebo Comparator: 2 Drug: placebo
oral administration 12 hours intervals

Active Comparator: 3 Drug: paroxetine
oral 20 mg/day




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

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00825058


Locations
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Bulgaria
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Croatia
Sanofi-Aventis Administrative Office
Zagreb, Croatia
Czech Republic
Sanofi-Aventis Administrative Office
Praha, Czech Republic
Estonia
Sanofi-Aventis Administrative Office
Tallinn, Estonia
France
Sanofi-Aventis Administrative Office
Paris, France
Montenegro
Sanofi-Aventis Administrative Office
Montenegro, Montenegro
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Serbia
Sanofi-Aventis Administrative Office
Belgrade, Serbia
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: ICD CSD Sanofi

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Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00825058     History of Changes
Other Study ID Numbers: EFC5374
First Posted: January 19, 2009    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by Sanofi:
Depression

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Paroxetine
Amibegron
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