Efficacy and Safety of SR58611 Compared to Placebo and Paroxetine

Sanofi

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorders

Treatments: Drug: amibegron (SR58611A); Drug: paroxetine; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00825058

EFC5374

Details and patient eligibility

About

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.

Enrollment: 317 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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317 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: amibegron (SR58611A)

2

Placebo Comparator group

Treatment:

Drug: placebo

3

Active Comparator group

Treatment:

Drug: paroxetine