Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2004-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

amibegron (SR58611A)

Intervention Type DRUG

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

2

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral administration 12 hours intervals

3

Group Type ACTIVE_COMPARATOR

paroxetine

Intervention Type DRUG

oral 20 mg/day

Interventions

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amibegron (SR58611A)

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

Intervention Type DRUG

placebo

oral administration 12 hours intervals

Intervention Type DRUG

paroxetine

oral 20 mg/day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No