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

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ClinicalTrials.gov Identifier: NCT00825019
Recruitment Status : Completed
First Posted : January 19, 2009
Last Update Posted : March 25, 2009
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief Summary:

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 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 : September 2003
Actual Primary Completion Date : October 2004
Actual Study Completion Date : December 2004

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Arms and Interventions
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Arm Intervention/treatment
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


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

Eligibility Criteria
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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.
Contacts and Locations
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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): NCT00825019


Locations
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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: ICD CSD Sanofi
More Information
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Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00825019     History of Changes
Other Study ID Numbers: EFC5379
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