A Study Evaluating the Safety and Tolerability of Abrupt Discontinuation of Saredutant in Patients With Depression
The primary objective is to evaluate the safety and tolerability of abrupt discontinuation of saredutant over 1 week in outpatients with depression who completed 8 weeks of treatment with saredutant 100 mg once daily.
The secondary objective is to evaluate the safety and tolerability of 8 weeks of open-label treatment with saredutant 100 mg once daily in outpatients with depression.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A 1-week, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of Abrupt Discontinuation of Saredutant in Outpatients With Depression Who Completed 8 Weeks of Treatment With Saredutant 100 mg Once Daily|
- The primary endpoint is the change from baseline (Day 56) to Day 63 in the post-baseline average daily number of discontinuation-emergent signs or symptoms from the 17-item Discontinuation-Emergent Signs and Symptoms checklist.
- The main secondary endpoints are the change from baseline in the maximum number of post-baseline discontinuation-emergent signs or symptoms and the proportions of patients with any newly-occurring post-baseline discontinuation-emergent signs and symptoms
|Study Start Date:||January 2007|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429260
|United States, Pennsylvania|
|Malvern, Pennsylvania, United States, 19355|
|Study Director:||Clinical Sciences & Operations||Sanofi|