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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00256113 |
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 | Intervention | Phase |
---|---|---|
Depressive Disorder |
Drug: Saredutant succinate (SR48968C) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 467 |
Study Start Date: | December 2004 |
Study Completion Date: | December 2006 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
The study is a multicenter, multicountry, randomized, parallel-group, double blind, placebo and paroxetine-controlled study consisting of three segments (A, B, and C). Segment A is a 1-week, placebo, single-blind period and Segment B is an 8-week, double blind period. Patients completing Segment B may be eligible for enrollment into Segment C, a 44-week, double blind extension. All randomized patients must complete a post-study visit 1 week after intake of the last dose of study medication.
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada | |
Sanofi-aventis Administrative Office | |
Laval, Canada | |
Chile | |
Sanofi-aventis Administrative Office | |
Santiago, Chile | |
Croatia | |
Sanofi-aventis Administrative Office | |
Zagreb, Croatia | |
Czech Republic | |
Sanofi-aventis Administrative Office | |
Praha, Czech Republic | |
Estonia | |
Sanofi-aventis Administrative Office | |
Tallinn, Estonia | |
Germany | |
Sanofi-aventis Administrative Office | |
Berlin, Germany | |
Mexico | |
Sanofi-aventis Administrative Office | |
Mexico, Mexico | |
Portugal | |
Sanofi-aventis Administrative Office | |
Porto Salvo, Portugal |
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC5575 |
Study First Received: | November 7, 2005 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00256113 History of Changes |
Health Authority: | Canada: Health Canada; Germany: Ethics Commission; Estonia: The State Agency of Medicine |
depression antidepressive agents controlled clinical trial |
Depression Mental Disorders Mood Disorders Depressive Disorder, Major |
Depressive Disorder Antidepressive Agents Behavioral Symptoms |
Pathologic Processes Disease Depression Mental Disorders |
Mood Disorders Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |