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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00206128 |
The purpose of this study is to determine that the efficacy of the sustained release (SR) formulation of quetiapine (Seroquel) is not inferior to the immediate release (IR) formulation.
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, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 6-Week Multicenter, Double-Blind, Randomized, Parallel-Group, Phase 3 Study to Evaluate the Feasibility of Switching From Immediate-Release Quetiapine Fumarate (SEROQUEL) to Sustained-Release Quetiapine Fumarate in Outpatients With Schizophrenia (Abbreviated) |
Enrollment: | 454 |
Study Start Date: | November 2004 |
Study Completion Date: | March 2006 |
Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
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 Seroquel Medical Science Director, MD | AstraZeneca |
Study ID Numbers: | D1444C00146 |
Study First Received: | September 13, 2005 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00206128 |
Health Authority: | United States: Food and Drug Administration |
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 |