Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT00825058

Collaborator

(none)

317

Enrollment

Locations

Arms

Duration (Months)

39.6

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

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

Study Type:

Interventional

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 :

Nov 1, 2003

Actual Primary Completion Date :

May 1, 2004

Actual Study Completion Date :

Oct 1, 2004

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

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. [6 weeks]

Secondary Outcome Measures

HAM-D subscores [6 weeks]
HAM-D responders and remitters [6 weeks]
HAM-A total score and subscores [6 weeks]
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]
clinical monitoring of adverse events (AEs) [6 weeks]
laboratory parameters [6 weeks]
electrocardiogram (ECG) parameters, change in vital signs and 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	Country
1	Sanofi-Aventis Administrative Office	Sofia	Bulgaria
2	Sanofi-Aventis Administrative Office	Zagreb	Croatia
3	Sanofi-Aventis Administrative Office	Praha	Czech Republic
4	Sanofi-Aventis Administrative Office	Tallinn	Estonia
5	Sanofi-Aventis Administrative Office	Paris	France
6	Sanofi-Aventis Administrative Office	Montenegro	Montenegro
7	Sanofi-Aventis Administrative Office	Gouda	Netherlands
8	Sanofi-Aventis Administrative Office	Belgrade	Serbia