Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine

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ClinicalTrials.gov Identifier: NCT00825058

Recruitment Status : Completed

First Posted : January 19, 2009

Last Update Posted : March 25, 2009

Sponsor:

Information provided by:

Sanofi

Study Description

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

Study Design

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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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Depression

Drug Information available for: Paroxetine Paroxetine hydrochloride Paroxetine hydrochloride hemihydrate Paroxetine Mesylate

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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 [ Time Frame: 6 weeks ]
HAM-D responders and remitters [ Time Frame: 6 weeks ]
HAM-A total score and subscores [ Time Frame: 6 weeks ]
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 ]
clinical monitoring of adverse events (AEs) [ Time Frame: 6 weeks ]
laboratory parameters [ Time Frame: 6 weeks ]
electrocardiogram (ECG) parameters, change in vital signs and body weight [ Time Frame: 6 weeks ]

Eligibility Criteria

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

Contacts and Locations

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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

More Information

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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

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