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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00351169 |
To evaluate the efficacy and safety of quetiapine fumarate sustained release (Seroquel SR) in the treatment of 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 SR Drug: Escitalopram |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Multi-Centre, Double-Blind, Randomised, Parallel Group, Placebo- Controlled and Active Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) as Mono- Therapy in the Treatment of Adult Patients With Major Depressive Disorder |
Estimated Enrollment: | 450 |
Study Start Date: | May 2006 |
Study Completion Date: | June 2007 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Willie Earley, MD | AstraZeneca |
Study ID Numbers: | D1448C00004, AMBER, EUDRACT No: 2005-005052-40 |
Study First Received: | July 11, 2006 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00351169 |
Health Authority: | Mexico: National Institute of Public Health, Health Secretariat |
Major Depressive Disorder MDD |
Quetiapine Depression Mental Disorders Infectious Mononucleosis Mood Disorders Depressive Disorder, Major |
Dexetimide Depressive Disorder Citalopram Serotonin Behavioral Symptoms |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Tranquilizing Agents Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Pathologic Processes Serotonin Agents Therapeutic Uses Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |