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

Sanofi527 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

527

Conditions

Major Depressive Disorders

Interventions

amibegron (SR58611A)DRUG

oral administration of 300 mg twice daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

Sanofi-Aventis Administrative Office

Buenos Aires, Argentina

Sanofi-Aventis Administrative Office

Santiago, Chile

Sanofi-Aventis Administrative Office

Athens, Greece

Outcomes

Primary Outcomes

Clinical monitoring of adverse events (AEs), laboratory parameters, vital signs, physical examinations, and physician withdrawal checklists

Time frame: 54 weeks

Secondary Outcomes

17-item Hamilton Depression rating Scale, Clinical Global Impression, Sheehan Disability Scale, Qol Enjoyment and satisfaction Questionnaire - Short Form,Medical Outcomes Study Short Form, Endicott Work Productivity Scale.

Time frame: 54 weeks

Data from ClinicalTrials.gov

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