Efficacy and Safety of SR58611A in Patients With Major Depressive Disorder (PHOENIX)

Sanofi

Status and phase

Completed

Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: SR58611A

Study type

Interventional

Funder types

Industry

Identifiers

NCT00252330

EFC5116

Details and patient eligibility

About

Full description

To evaluate the efficacy of a fixed dose of SR58611A(350 mg q12) compared to placebo in patients with MajorDepressive Disorder (MDD) using escitalopram (10 mgqd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated. The present study is an 8-week, double-blind, placebo- and escitalopram-controlled, randomized, parallel-group study. A 1-week, placebo, single-blind period precedes the 8-week randomized treatment period and an optional 18-week, double-blind extension period follows the randomized treatment period. A Safety Follow up Visit is scheduled 1 week after the acute and extension period, or early termination. Escitalopram, a selective serotonin reuptake inhibitor (SSRI), an approved treatment for MDD, is chosen as a positive control agent in this study. The dose of 10 mg is within the approved dose range with no need for dose adjustment in elderly patients. This trial is designed to formally compare the efficacy, safety, and tolerability of SR58611A to placebo. Escitalopram is used as a positive control.

Enrollment

476 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Main inclusion criteria:

1. Out-patients, 18 year and older.
1. Major Depressive Disorder (MDD) with a recurrentMajor Depressive Episode (MDE) according to DSMIV-TR criteria
1. Duration of current episode is at least of 6 weeksunless severity of symptoms justifies shorter duration.
1. Patients have been treated or hospitalized for aprevious episode, or a previous episode requiredantidepressant treatment(s) at the recommended doselevel for a continuous total duration of at least 2months.

Exclusion criteria

Main exclusion criteria:

1. Patients at immediate risk for suicidal behavior
1. Patients with a MDE with psychotic features, catatonic features, seasonal pattern or postpartum onset
1. The duration of the current depressive episode is greater than 2 years
1. Patients whose current depressive episode is secondary to a general medical condition
1. Patients with a lifetime history of (1) bipolar disorder, (2) psychotic disorder, (3) antisocial personality disorder
1. Patients who have received non-pharmacologic, somatic treatments for psychiatric disease
1. Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within 3 months prior to screening