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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00388973 |
The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve elderly patients with major depressive disorder.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Condition | Intervention | Phase |
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Major Depressive Disorder |
Drug: Quetiapine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR) in the Treatment of Elderly Patients With Major Depressive Disorder |
Estimated Enrollment: | 300 |
Study Start Date: | September 2006 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 66 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Catherine Datto, MD | AstraZeneca |
Responsible Party: | AstraZeneca Pharmaceuticals ( Martin Brecher, Seroquel Medical Science Director ) |
Study ID Numbers: | D1448C00014, EUDRACT No: 2006-001196-38 |
Study First Received: | October 16, 2006 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00388973 |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Finland: National Agency for Medicines; Estonia: The State Agency of Medicine; Lithuania: State Medicine Control Agency - Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: Ministry of Health |
Major Depressive Disorder MDD |
Quetiapine Depression Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |
Tranquilizing Agents Pathologic Processes Disease Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |