A Fifty-two-week Study to Evaluate the Safety of Saredutant in Adult and Elderly Patients With Depression
The purpose of the study is to evaluate the long-term safety of saredutant (or SR48968C) in adult and elderly patients with depression.The primary objective is to evaluate the long-term safety and tolerability of a 100 mg dose of saredutant in adult and elderly patients with depression. The secondary objective is to evaluate blood levels of saredutant.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Fifty-two-week, Multicenter, Open-label Study Evaluating the Long-term Safety and Tolerability of Saredutant in Adult and Elderly Patients With Major Depressive Disorder|
- The primary outcome is the proportion of patients experiencing at least one treatment-emergent adverse event.
- The main secondary outcomes are incidences of potentially clinically significant abnormalities and the changes from baseline in the values for clinical laboratories, vital signs, and electrocardiogram parameters.
|Study Start Date:||May 2005|
|Study Completion Date:||April 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
The study is a multicenter, US, open-label study consisting of two segments (A and B). Segment A is a minimum 1-week (maximum 4-week) screening period and Segment B is a 52-week, open-label period. All treated patients must complete a post-study telephone visit and a post-study office visit 3 days and 1 week, respectively, after intake of the last dose of study medication.