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Am J Geriatr Psychiatry 9:346-360, November 2001
© 2001 American Association for Geriatric Psychiatry


Special Article

National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE)

Alzheimer Disease Trial Methodology

Lon S. Schneider, M.D., Pierre N. Tariot, M.D., Constantine G. Lyketsos, M.D., M.H.S., Karen S. Dagerman, M.S., Kenneth L. Davis, M.D., Sonia Davis, Dr.P.H., John K. Hsiao, M.D., Dilip V. Jeste, M.D., Ira R. Katz, M.D., Jason T. Olin, Ph.D., Bruce G. Pollock, M.D., Ph.D., Peter V. Rabins, M.D., Robert A. Rosenheck, M.D., Gary W. Small, M.D., Barry Lebowitz, Ph.D., and Jeffery A. Lieberman, M.D.

Received April 16, 2001; revised June 22, 2001; accepted June 25, 2001. From the Clinical Antipsychotic Trials of Intervention Effectiveness Program of the National Institute of Mental Health at the University of North Carolina at Chapel Hill. Address correspondence to Dr. Schneider, Professor of Psychiatry, Neurology, and Gerontology, University of Southern California, Keck School of Medicine, 1975 Zonal Ave, KAM-400, Los Angeles, CA 90033. e-mail: lschneid{at}usc.edu

The authors describe the development of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) protocol for Alzheimer disease (AD), a trial developed in collaboration with the National Institute of Mental Health (NIMH), assessing the effectiveness of atypical antipsychotics for psychosis and agitation occurring in AD outpatients. They provide an overview of the methodology utilized in the trial as well as the clinical-outcomes and effectiveness measures that were implemented.

Key Words: Alzheimer Disease • Clinical Trials • Antipsychotics




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