An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00250601|
Recruitment Status : Completed
First Posted : November 8, 2005
Last Update Posted : February 17, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder||Drug: Saredutant succinate (SR48968C)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||460 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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.|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250601
|United States, New Jersey|
|Bridgewater, New Jersey, United States, 08807|
|Study Director:||Clinical Sciences & Operations||Sanofi|