Long Term Safety and Tolerability of SR58611 in Patients With Major Depressive Disorder
- Registration Number
- NCT00855530
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 527
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 amibegron (SR58611A) -
- Primary Outcome Measures
Name Time Method Clinical monitoring of adverse events (AEs), laboratory parameters, vital signs, physical examinations, and physician withdrawal checklists 54 weeks
- Secondary Outcome Measures
Name Time Method 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. 54 weeks
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇹🇳Megrine, Tunisia