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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00206115 |
The purpose of this 6-week study is to determine whether treatment with Seroquel® Sustained Release (SR) is more effective than placebo in the treatment of acute schizophrenia.
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 |
---|---|---|
Schizophrenic Disorder |
Drug: Seroquel Sustained Release (SR) Drug: Seroquel Immediate Release (IR) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 6-Week, Multicenter, Double-Blind, Double-Dummy, Randomized Comparison of the Efficacy & Safety of Sustained-Release Formulation Quetiapine Fumarate (SEROQUEL) & Placebo in the Treatment of Acutely Ill Patients With Schizophrenia |
Estimated Enrollment: | 535 |
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: | D1444C00132 |
Study First Received: | September 14, 2005 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00206115 |
Health Authority: | United States: Food and Drug Administration; Bulgaria: Bulgarian Drug Agency; Greece: National Organization of Medicines; India: Ministry of Health; Philippines: Bureau of Food and Drugs; Romania: State Institute for Drug Control; Russia: Pharmacological Committee, Ministry of Health; South Africa: Medicines Control Council |
Schizophrenic disorder |
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 |