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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00825019

Collaborator

(none)

306

Enrollment

Location

Arms

Duration (Months)

20.4

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Sep 1, 2003

Actual Primary Completion Date :

Oct 1, 2004

Actual Study Completion Date :

Dec 1, 2004

Arms and Interventions

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

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

Primary Outcome Measures

change from baseline of the total score of the HAM-D 17 items [6 weeks]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey	United States	08807

Sponsors and Collaborators

Sanofi

Investigators

Study Director: ICD CSD, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00825019

Other Study ID Numbers:

EFC5379

First Posted:

Jan 19, 2009

Last Update Posted:

Mar 25, 2009

Last Verified:

Mar 1, 2009

Keywords provided by , ,

Depression

Additional relevant MeSH terms:

Depressive Disorder

Depressive Disorder, Major

Paroxetine

Amibegron

Study Results

No Results Posted as of Mar 25, 2009