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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00234377 |
The purpose of this study is to document the clinical benefit of quetiapine (Seroquel) sustained release (SR) after switching from another ongoing antipsychotic treatment, regardless of the reason for the switch.
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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Schizophrenia |
Drug: Seroquel SR |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A 12-Week International, Multicenter, Open Label, Non-Comparative Study to Evaluate the Feasibility of Switching Any Antipsychotic Treatment to Sustained-Release Quetiapine Fumarate (SEROQUEL®) in Patients With Schizophrenia |
Estimated Enrollment: | 550 |
Study Start Date: | November 2004 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | AstraZeneca CNS Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | D1444C00147 |
Study First Received: | October 5, 2005 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00234377 |
Health Authority: | Finland: National Agency for Medicines; Australia: Department of Health and Ageing Therapeutic Goods Administration; Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Malaysia: Ministry of Health; South Africa: Medicines Control Council; Spain: Spanish Agency of Medicines; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Schizophrenia |
Schizophrenia Quetiapine Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Tranquilizing Agents Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |