Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00825058

Purpose

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

MedlinePlus related topics: Depression

Drug Information available for: Paroxetine Paroxetine hydrochloride SR 58611A Paroxetine Mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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.

Further study details as provided by Sanofi-Aventis:

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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
HAM-D responders and remitters [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
HAM-A total score and subscores [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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 ]
clinical monitoring of adverse events (AEs) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
laboratory parameters [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
electrocardiogram (ECG) parameters, change in vital signs and body weight [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	317
Study Start Date:	November 2003
Study Completion Date:	October 2004
Primary Completion Date:	May 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: amibegron (SR58611A) oral administration 2 X 350mg/day at 12 hours intervals
2: Placebo Comparator	Drug: placebo oral administration 12 hours intervals
3: Active Comparator	Drug: paroxetine oral 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: NCT00825058

Locations

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-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC5374
Study First Received:	January 16, 2009
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00825058 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Sanofi-Aventis:

Depression

Study placed in the following topic categories:

Neurotransmitter Agents
Depression
Adrenergic beta-Agonists
Adrenergic Agents
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Paroxetine
Serotonin Uptake Inhibitors

Adrenergic Agonists
Recurrence
Serotonin
Behavioral Symptoms
Mental Disorders
SR 58611A
Mood Disorders
Antidepressive Agents, Second-Generation
Antidepressive Agents

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Adrenergic Agents
Adrenergic beta-Agonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Paroxetine
Serotonin Uptake Inhibitors

Adrenergic Agonists
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
SR 58611A
Mood Disorders
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on May 07, 2009