Long Term Safety and Tolerability of SR58611 in Patients With Major Depressive Disorder

Sanofi

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorders

Treatments: Drug: amibegron (SR58611A)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00855530

LTS4848

Details and patient eligibility

About

Primary objective:

• To evaluate the long-term safety and tolerability of SR58611A (amibegron) patients with major depressive disorder (MDD).

Secondary objective:

• To determine plasma concentrations of SR58878 (the active metabolite of SR58611A), for pharmacokinetic population analyses, to evaluate the quality of life (QoL) in patients with MDD, and to evaluate the efficacy of amibegron in patients with MDD.

Enrollment: 527 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• patients as defined by Diagnosis and Statistical Manual of Mental Disorders, recurrent episode for at least 1 month prior to entry into the study, and with a total score of > 18 on the Hamilton Depression Rating Scale (HAM-D) 17-items.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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527 participants in 1 patient group

1

Experimental group

Treatment:

Drug: amibegron (SR58611A)