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| Sponsor: | AstraZeneca |
|---|---|
| Information provided by: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00234377 |
Purpose
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 |
|---|---|---|
|
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 |
| Study Completion Date: | May 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 27 Study Locations| Study Director: | AstraZeneca CNS Medical Science Director, MD | AstraZeneca |
More Information
| Study ID Numbers: | D1444C00147 |
| Study First Received: | October 5, 2005 |
| Last Updated: | March 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00234377 History of Changes |
| Health Authority: | Finland: Finnish Medicines Agency; 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 |
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Schizophrenia |
|
Schizophrenia Quetiapine Tranquilizing Agents Mental Disorders Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions Schizophrenia and Disorders with Psychotic Features |