Antipsychotic Trials in Schizophrenia: The CATIE Project

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Overview

Antipsychotic medications are a key treatment for schizophrenia and sales of antipsychotic drugs approach $20 billion per year, with fierce marketing between the makers of the drugs. The U.S. National Institute of Mental Health sponsored the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project to provide independent information about the comparative effectiveness of medications. CATIE was the largest, longest and most comprehensive study of schizophrenia to date. Conducted under rigorous double-blind conditions, Antipsychotic Trials in Schizophrenia presents the definitive archival results of this landmark study. The core of the book consists of chapters focused on specific outcomes that set the CATIE findings in a wider context. Also included are chapters on the design, statistical analyses and implications for researchers, clinicians and policy makers. Psychiatrists, psychiatric researchers, mental health policy makers and those working in pharmaceutical companies will all find this to be essential reading.

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Editorial Reviews

Doody's Review Service
Reviewer: Michael Joel Schrift, D.O., M.A.(University of Illinois at Chicago College of Medicine)
Description: This valuable book covers the landmark CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness) trial, "the largest, longest and most comprehensive study of schizophrenia to date." The conclusions for psychiatry and for the treatment of schizophrenia are sad and disappointing: after all these years, the newer and expensive antipsychotic medications are not significantly better than the older and less expensive conventional antipsychotic agents. This book details the design, statistical analyses, and implications of this study on clinicians and researchers. Written and edited by the nationally recognized clinician-researchers involved in the study, this book is a welcome addition to the field.
Purpose: The purpose is to provide the details as well as the implications and ramifications of the findings of this landmark study.
Audience: The intended audience includes researchers, clinicians, policymakers, and hopefully pharmaceutical corporation CEOs.
Features: All of the important aspects of the study are discussed in detail, including the study design and protocol development process, statistical considerations, effectiveness and efficacy, cost-effectiveness and cost-benefit analysis, psychosocial functioning assessments, assessment of neurocognition, family outcomes, extrapyramidal side effects, metabolic side effects, substance use in schizophrenia, violence in schizophrenia, genetic investigations, human subject considerations, population pharmacokinetics, and implications for practice and policy. Each chapter concludes with relevant and timely citations of the scientific literature.
Assessment: This important and timely book contains the "definitive archival results" of this landmark study. At least for me, in terms of the countless me-too drugs designed by the pharmaceutical industry, this book and study demonstrate that the emperor has no clothes. Unfortunately for psychiatry, the efficacy of almost all of our treatments has not improved for all the illnesses that we treat. The side effects and costs have changed, however.
From The Critics
Reviewer: Michael Joel Schrift, D.O., M.A.(University of Illinois at Chicago College of Medicine)
Description: "This valuable book covers the landmark CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness) trial, "the largest, longest and most comprehensive study of schizophrenia to date." The conclusions for psychiatry and for the treatment of schizophrenia are sad and disappointing: after all these years, the newer and expensive antipsychotic medications are not significantly better than the older and less expensive conventional antipsychotic agents. This book details the design, statistical analyses, and implications of this study on clinicians and researchers. Written and edited by the nationally recognized clinician-researchers involved in the study, this book is a welcome addition to the field. "
Purpose: The purpose is to provide the details as well as the implications and ramifications of the findings of this landmark study.
Audience: The intended audience includes researchers, clinicians, policymakers, and hopefully pharmaceutical corporation CEOs.
Features: All of the important aspects of the study are discussed in detail, including the study design and protocol development process, statistical considerations, effectiveness and efficacy, cost-effectiveness and cost-benefit analysis, psychosocial functioning assessments, assessment of neurocognition, family outcomes, extrapyramidal side effects, metabolic side effects, substance use in schizophrenia, violence in schizophrenia, genetic investigations, human subject considerations, population pharmacokinetics, and implications for practice and policy. Each chapter concludes with relevant and timely citations of the scientific literature.
Assessment: "This important and timely book contains the "definitive archival results" of this landmark study. At least for me, in terms of the countless me-too drugs designed by the pharmaceutical industry, this book and study demonstrate that the emperor has no clothes. Unfortunately for psychiatry, the efficacy of almost all of our treatments has not improved for all the illnesses that we treat. The side effects and costs have changed, however. "
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Product Details

  • ISBN-13: 9780521895330
  • Publisher: Cambridge University Press
  • Publication date: 4/1/2010
  • Pages: 330
  • Product dimensions: 6.00 (w) x 9.30 (h) x 0.80 (d)

Meet the Author

Scott Stroup is Professor of Psychiatry at the University of North Carolina, Chapel Hill, USA. He was co-Principal Investigator of the CATIE Schizophrenia Study.

Jeffrey A. Lieberman is Chairman, Department of Psychiatry, College of Physicians and Surgeons, Columbia University, Director, New York State Psychiatric Institute and Director, Lieber Center for Schizophrenia Research Psychiatrist-in-Chief at New York Presbyterian Hospital and Columbia University Medical Center, New York, USA.

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Table of Contents

List of contributors ix

Acknowledgments xi

Introduction xiii

1 Study design and protocol development process T. Scott Stroup Joseph P. McEvoy Jeffrey A. Lieberman 1

2 Statistical considerations Sonia M. Davis Gary G. Koch Robert A. Rosenheck Vicki G. Davis 22

3 Effectiveness and efficacy: staying on treatment and symptom reduction Joseph P. McEvoy T. Scott Stroup Jeffrey A. Lieberman 39

4 Cost-effectiveness and cost-benefit analysis Robert A. Rosenheck Douglas L. Leslie 57

5 Psychosocial functioning in patients with chronic schizophrenia: findings from the NIMH CATIE study Marvin S. Swartz 80

6 Neurocognition Richard S. E. Keefe 97

7 Vocational outcomes Sandra G. Resnick Robert A. Rosenheck 120

8 Family outcomes Deborah A. Perlick Richard Kaczynski Robert A. Rosenheck 133

9 Extrapyramidal side effects Stanley N. Caroff Del D. Miller Robert A. Rosenheck 156

10 Metabolic side effects and risk of cardiovascular disease Jonathan M. Meyer Donald C. Goff Joseph P. McEvoy 173

11 Substance use in persons with schizophrenia: incidence, baseline correlates, and effects on outcome Fred Reimherr Marvin S. Swartz John L. Olsen 189

12 Violence in schizophrenia: prevalence, correlates, and treatment effectiveness Jeffrey Swanson Richard Van Dorn 207

13 Genetic investigations in the Catie sample James J. Crowley Patrick F. Sullivan 237

14 Human subjects considerations T. Scott Stroup Paul Appelbaum 255

15 Population pharmacokinetics of antipsychotics Kristin L. Bigos Robert R. Bies Stephen R. Marder Bruce G. Pollock 267

16 Implications for research design and study implementation T. Scott Stroup Jeffrey A. Lieberman 281

17 Conclusion and implications for practice and policy Robert A. Rosenheck T. Scott Stroup Jeffrey A. Lieberman 288

Index 307

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