An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression
The purpose of the study is to evaluate the efficacy and safety of saredutant (or SR48968C) in patients with depression.
The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with depression.
The secondary objectives are to evaluate the safety of saredutant, to evaluate the efficacy of saredutant on disability and quality of life in patients with depression, and to evaluate blood levels of saredutant.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||An Eight-Week, Multicenter, Double-blind, Placebo-controlled Study Evaluating the Efficacy, Safety, and Tolerability of One Fixed 100 mg Dose of Saredutant in Patients With Major Depressive Disorder.|
- The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Depression Rating Scale (HAM-D) total score.
- The main secondary outcomes are the changes from baseline to Day 56 of treatment in the HAM-D depressed mood item, the Montgomery Asberg Depression Rating Scale total, and the Clinical Global Impression Severity of Illness scores.
|Study Start Date:||April 2005|
|Study Completion Date:||October 2006|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00250614
|United States, New Jersey|
|Sanofi-Aventis Administrative Office|
|Bridgewater, New Jersey, United States, 08807|
|Study Director:||Lisa ARVANITIS, MD||Sanofi|