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Chapter 1 - Study design and protocol development process

Published online by Cambridge University Press:  03 May 2010

T. Scott Stroup
Affiliation:
Columbia University, New York
Jeffrey A. Lieberman
Affiliation:
Columbia University, New York
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Summary

This chapter describes the development of the study designed to assess the effectiveness of antipsychotic drugs for persons with chronic schizophrenia. The protocol was developed by a team of academic investigators through an inclusive, iterative, and systematic process. The Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) program was designed to address a discrepancy between research demonstrating the efficacy of antipsychotic drugs and disappointing findings regarding their effectiveness and the ostensible superiority of second-generation antipsychotic (SGA) medications relative to first-generation antipsychotic drugs (FGA) medications. Some of the key study design decisions made by the Schizophrenia Protocol Development Committee, with input from various stakeholder groups, and their rationales are reviewed in this chapter. The study design was that of a practical clinical trial intended to evaluate the effectiveness of treatments in everyday settings to generate results intended to inform clinicians, administrators, policy makers, and patients.
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Antipsychotic Trials in Schizophrenia
The CATIE Project
, pp. 1 - 21
Publisher: Cambridge University Press
Print publication year: 2010

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