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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00322595 |
The primary purpose of this study is to evaluate the efficacy of (SEROQUEL SR™ ) quetiapine fumarate sustained-release (SR) compared to placebo in the treatment of anxiety symptoms in patients with generalized anxiety disorder (GAD).
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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Generalized Anxiety Disorder |
Drug: Quetiapine fumarate Drug: Paroxetine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An International, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (Seroquel SR™ ) in the Treatment of Generalized Anxiety Disorder (SILVER) |
Estimated Enrollment: | 800 |
Study Start Date: | May 2006 |
Study Completion Date: | May 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: | Seroquel Medical Science Director | AstraZeneca |
Study ID Numbers: | D1448C00011, 2005-005054-46, Silver |
Study First Received: | May 5, 2006 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00322595 |
Health Authority: | Denmark: Danish Medicines Agency; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Bulgaria: Bulgarian Drug Agency; Canada: Health Canada; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Finland: National Agency for Medicines; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Mexico: Federal Commission for Protection Against Health Risks; Norway: Norwegian Medicines Agency; Romania: National Medicines Agency; Slovakia: State Institute for Drug Control; South Africa: Medicines Control Council; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency |
Anxiety GAD |
Quetiapine Anxiety Disorders Mental Disorders Paroxetine Serotonin |
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 |