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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

317

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Nov 2003

Shorter than P25 for phase_3

Geographic Reach

8 countries

8 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

11 months study duration

Study Start

First participant enrolled

November 1, 2003

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed

4.3 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2009

Completed

3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2009

Completed

Last Updated

March 25, 2009

Status Verified

March 1, 2009

Enrollment Period

6 months

First QC Date

January 16, 2009

Last Update Submit

March 24, 2009

Conditions

Major Depressive Disorders

Keywords

Depression

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (10)

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
+5 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

Drug: amibegron (SR58611A)

2

PLACEBO COMPARATOR

Drug: placebo

3

ACTIVE COMPARATOR

Drug: paroxetine

Interventions

amibegron (SR58611A)DRUG

oral administration 2 X 350mg/day at 12 hours intervals

placeboDRUG

oral administration 12 hours intervals

paroxetineDRUG

oral 20 mg/day

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.