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

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:

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

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 (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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 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

ClinicalTrials.gov processed this record on September 30, 2016