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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00319709 |
The purpose of the study is to evaluate the efficacy and safety of SR58611A in elderly patients with depression.The primary objective is to evaluate the efficacy of a 700 mg dose of SR58611A compared to placebo in elderly patients with depression. The secondary objectives are to evaluate the safety of SR58611A and to evaluate the efficacy of SR58611A on disability and quality of life in elderly patients with depression.
Condition | Intervention | Phase |
---|---|---|
Depressive Disorder |
Drug: SR58611A |
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, Double-Blind Placebo Controlled, Multicenter Study Evaluating the Efficacy, Safety, Tolerability of a Fixed Dose of SR58611A (350 mg q12) in Elderly Patients With Major Depressive Disorder (MDD) |
Enrollment: | 288 |
Study Start Date: | April 2006 |
Study Completion Date: | August 2007 |
Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Bulgaria | |
Sanofi-Aventis Administrative Office | |
Sofia, Bulgaria | |
Finland | |
Sanofi-Aventis Administrative Office | |
Helsinki, Finland | |
Romania | |
Sanofi-Aventis Administrative Office | |
Bucuresti, Romania | |
Serbia | |
Sanofi-Aventis Administrative Office | |
Belgrade, Serbia | |
Slovakia | |
Sanofi-Aventis Administrative Office | |
Bratislava, Slovakia |
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC4846, EudraCT 2005-005597-67 |
Study First Received: | April 28, 2006 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00319709 |
Health Authority: | Poland: Ministry of Health; Finland: National Agency for Medicines; Slovakia: State Institute for Drug Control |
depression antidepressive agents controlled clinical trial |
Depression Mental Disorders SR 58611A Mood Disorders |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |
Neurotransmitter Agents Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action Adrenergic Agents |
Adrenergic beta-Agonists Physiological Effects of Drugs Pharmacologic Actions Adrenergic Agonists |