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Schizophrenia Bulletin 2003 29(1):57-72;
© 2003 by Oxford University Press and the Maryland Psychiatric Research Center (MPRC)
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© Oxford University Press

Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE): Alzheimer's Disease Trial

Lon S. Schneider, M.D., M. Saleem Ismail, M.D., Karen Dagerman, M.S., Sonia Davis, DrPH, Jason Olin, Ph.D., Dennis McManus, Eric Pfeiffer, J. Michael Ryan, David L. Sultzer and Pierre N. Tariot, M.D.
Professor of Psychiatry, Neurology, and Gerontology, Department of Psychiatry and the Behavioral Sciences, Keck School of Medicine, University of Southern California Los Angeles, CA. M
Senior Instructor in Psychiatry, University of Rochester Medical Center Rochester, NY
Project Specialist for CATIE Project, Department of Psychiatry and the Behavioral Sciences, Keck School of Medicine, University of Southern California
Director of Biostatistics, Quintiles, Inc., Morrisville, NC; and Adjunct Assistant Professor, Department of Biostatistics, University of North Carolina Chapel Hill, NC
Chief, Geriatric Psychopharmacology Program, National Institute of Mental Health, National Institutes of Health Bethesda, MD
Professor of Psychiatry, Medicine, and Neurology, University of Rochester School of Medicine, Monroe Community Hospital Rochester, NY

Send reprint requests to Dr. L.S. Schneider, University of Southern California Keck School of Medicine, 1975 Zonal Ave., KAM-400, Los Angeles, CA 90033; e-mail: lschneid{at}usc.edu

This article describes the development of the protocol for the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Alzheimer's disease trial, which was developed in collaboration with the National Institute of Mental Health to assess the effectiveness of atypical antipsychotics for psychosis and/or agitation occurring in outpatients with Alzheimer's disease. The article provides a detailed description of the methodology used in the trial as well as the clinical outcomes and effectiveness measures incorporated into it, discussing the most salient issues encountered in developing the design of the trial, as well as the unique features of the trial.

Keywords: Alzheimer's disease / atypical antipsychotic / psychosis / dementia / effectiveness


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