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Schizophrenia Bulletin 2003 29(1):45-55;
© 2003 by Oxford University Press and the Maryland Psychiatric Research Center (MPRC)
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© Oxford University Press

Neurocognitive Assessment in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project Schizophrenia Trial: Development, Methodology, and Rationale

Richard S.E. Keefe, Ph.D., Richard C. Mohs, Ph.D., Robert M. Bilder, Ph.D., Philip D. Harvey, Ph.D., Michael F. Green, Ph.D., Herbert Y. Meltzer, M.D., James M. Gold, Ph.D. and Mary Sano, Ph.D.
Director, Neurocognitive Assessment Unit, Clinical Antipsychotic Trials of Intervention Effectiveness project; and Associate Professor of Psychiatry and Behavioral Sciences, Duke University Medical Center Durham, NC
Lilly Research Fellow, Eli Lilly and Company, Indianapolis, IN
Chief of Medical Psychology-Neuropsychology, Neuropsychiatric Institute and Hospital, Geffen School of Medicine, University of California Los Angeles
Professor of Psychiatry, Mt. Sinai School of Medicine
Professor in Residence, Department of Psychiatry and Biobehavioral Sciences, University of California Los Angeles, CA
Bixler Professor of Psychiatry, Vanderbilt University School of Medicine Nashville, TN
Associate Professor of Psychiatry, Maryland Psychiatric Research Center, University of Maryland School of Medicine Baltimore, MD
Professor, Department of Psychiatry, Mount Sinai School of Medicine, Bronx Veterans Medical Research Center Bronx, NY

Send reprint requests to Dr. R. Keefe, Box 3270, Duke University Medical Center, Durham, NC 27710; e-mail: rsekeefe{at}acpub.duke.edu

Patients with schizophrenia are severely impaired in crucial aspects of neurocognitive function. This impairment is the strongest clinical correlate of poor long-term outcome and adaptive dysfunction. Reports of neurocognitive enhancement with second generation antipsychotic medications have thus offered promise for improvement in the long-term outcome of patients with schizophrenia. However, the majority of these studies have had serious weaknesses in methodology, such as open-label design, small samples, or inappropriate dosing of medications. More recent studies have addressed these methodological issues but have been of short duration and have largely been sponsored by pharmaceutical companies. The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project is a unique opportunity to address the comparative neurocognitive effectiveness of available antipsychotic medications. This article describes the neurocognitive methods used in the schizophrenia trial of the CATIE project, including the selection and training of neurocognitive raters, patient inclusion criteria for assessment, rationale for the choice of neurocognitive instruments, and methodology for each neurocognitive test.

Keywords: Neurocognitive function / cognition / antipsychotic medications / neuropsychology / schizophrenia / clinical trials


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