Efficacy & Safety of Quetiapine Fumarate (SEROQUEL) & Placebo in the Treatment of Acutely Ill Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00085891
First received: June 16, 2004
Last updated: March 24, 2009
Last verified: March 2009

June 16, 2004
March 24, 2009
June 2004
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Change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment.
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Complete list of historical versions of study NCT00085891 on ClinicalTrials.gov Archive Site
Evaluation of secondary PANSS efficacy variables and Clinical Global Impression (CGI) variables at all study visits compared to baseline.
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Efficacy & Safety of Quetiapine Fumarate (SEROQUEL) & Placebo in the Treatment of Acutely Ill Patients With Schizophrenia
A 6-Week, Multicenter, Double-Blind, Double-Dummy, Randomized Comparison of the Efficacy and Safety of Sustained-Release Formulation Quetiapine Fumarate (SEROQUEL) and Placebo in the Treatment of Acutely Ill Patients With Schizophrenia

The purpose of this study is to demonstrate superior efficacy of sustained release quetiapine compared to placebo in patients with schizophrenia after receiving treatment for up to 6 weeks.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Schizophrenia
Drug: Quetiapine Fumarate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
535
September 2005
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Inclusion Criteria:

  • Patient is able to provide written informed consent before beginning any study related procedures
  • Patient has a documented clinical diagnosis of schizophrenia
  • Patient is able to understand and comply with the requirements of the study, as judged by a study investigator

Exclusion Criteria:

  • Patients with a history of non-compliance as judged by the study investigator
  • Patients with a known lack of response to previous treatment with quetiapine
  • Patients who have participated in another drug study within 4 weeks prior to enrollment into this study
  • Patients who have previously participated in this study or study D1444C00132
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00085891
D1444C00133
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AstraZeneca
Not Provided
Study Director: AstraZeneca Seroquel Medical Science Director, MD AstraZeneca
AstraZeneca
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP