© 2003 by Oxford University Press and the Maryland Psychiatric Research Center (MPRC)
The National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project: Schizophrenia Trial Design and Protocol Development
Associate Professor, Department of Psychiatry, University of North Carolina School of Medicine Chapel Hill, NC
Associate Professor, Department of Psychiatry, Duke University Durham, NC and Deputy Clinical Director, John Umstead Hospital Butner, NC
Professor, Department of Psychiatry and Behavioral Science, Duke University Durham, NC
Assistant Professor of Psychiatry, The University of Texas Southwestern Medical Center at Dallas TX
Professor, Department of Psychiatry and Behavioral Science, Stanford University School of Medicine Stanford, CA
Director, Psychiatry Research, New Mexico VA Health Care System, and Associate Professor of Psychiatry, University of New Mexico Albuquerque, NM
Chief Clinical Officer of Appalachian Behavioral Healthcare, and Assistant Professor of Psychiatry, Department of Specialty Medicine, Ohio University College of Osteopathic Medicine Athens, OH
Professor of Research Psychiatry and Interim Chair, Department of Psychiatry, University of Southern California Keck School of Medicine Los Angeles, CA
Medical Director, Valley Mental Health, and Director, Psychopharmacology Research Unit, Valley Mental Health Salt Lake City, UT
Thad and Alice Eure Professor of Psychiatry, Pharmacology, and Radiology and Vice-Chairman of Psychiatry, University of North Carolina School of Medicine Chapel Hill, NC
Send reprint requests to Dr. T. S. Stroup, CB# 7160, 10626 Neurosciences Hospital, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7160; e-mail: Scou_Stroup{at}med.unc.edu
The National Institute of Mental Health initiated the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) program to evaluate the effectiveness of antipsychotic drugs in typical settings and populations so that the study results will be maximally useful in routine clinical situations. The CATIE schizophrenia trial blends features of efficacy studies and large, simple trials to create a pragmatic trial that will provide extensive information about antipsychotic drug effectiveness over at least 18 months.
The protocol allows for subjects who receive a study drug that is not effective to receive subsequent treatments within the context of the study. Medication dosages are adjusted within a defined range according to clinical judgment. The primary outcome is all-cause treatment discontinuation because it represents an important clinical endpoint that reflects both clinician and patient judgments about efficacy and tolerability. Secondary outcomes include symptoms, side effects, neurocognitive functioning, and cost-effectiveness.
Approximately 50 clinical sites across the United States are seeking to enroll a total of 1,500 persons with schizophrenia. Phase 1 is a double-blinded randomized clinical trial comparing treatment with the second generation antipsychotics olanzapine, quetiapine, risperidone, and ziprasidone to perphenazine, a midpotency first generation antipsychotic. If the initially assigned medication is not effective, subjects may choose one of the following phase 2 trials: (1) randomization to open-label clozapine or a double-blinded second generation drug that was available but not assigned in phase 1; or (2) double-blinded randomization to ziprasidone or another second generation drug that was available but not assigned in phase 1. If the phase 2 study drug is discontinued, subjects may enter phase 3, in which clinicians help subjects select an open-label treatment based on individuals' experiences in phases 1 and 2.
Keywords: Randomized clinical trial / schizophrenia / antipsychotic drugs / effectiveness / longitudinal
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