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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: amibegron (SR58611A)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00385307

EFC6607

Details and patient eligibility

About

To evaluate the efficacy of two fixed doses of SR58611A (175 mg q12 and 350 mg q12) compared to placebo in patients with Major Depressive Disorder (MDD) using paroxetine (20 mg qd) as positive control. In addition, the tolerability and safety of SR58611A in patients with MDD will be evaluated.

Enrollment

680 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient with Major Depressive Disorder diagnosed according to Diagnostic and Statistical Manual of Mental Disorders DSM-IV-TR
Patient meets criteria for a recurrent Major Depressive Episode (MDE)
Patient meets severity assessments of depression specified by the study

Exclusion criteria

Patient is at immediate risk for suicidal behavior
Patient is with a unstable medical condition
Patient with psychotic features, catatonic features, seasonal pattern or postpartum onset
Patient has taken concomitant treatment that may interfere with valid collection or interpretation of study data
Patient has been treated with non-pharmacologic therapy intended to treat depression in the past 6 months
Patient has been treated with paroxetine (Paxil) within the previous 6 months
Patient is pregnant or breastfeeding, or likely to become pregnant during the course of the study