The National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project: Schizophrenia trial design and protocol development

T. Scott Stroup, Joseph Patrick McEvoy, Marvin S. Swartz, Matthew J. Byerly, Ira D. Glick, Jose M. Canive, Mark F. McGee, George M. Simpson, Michael C. Stevens, Jeffrey A. Lieberman

Research output: Contribution to journalReview article

453 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)15-31
Number of pages17
JournalSchizophrenia Bulletin
Volume29
Issue number1
DOIs
StatePublished - Jan 1 2003

Fingerprint

National Institute of Mental Health (U.S.)
Clinical Protocols
Antipsychotic Agents
Schizophrenia
Clinical Trials
olanzapine
Random Allocation
Pharmaceutical Preparations
Pragmatic Clinical Trials
Perphenazine
Risperidone
Clozapine
Program Evaluation
Therapeutics
Cost-Benefit Analysis
Randomized Controlled Trials
Population

Keywords

  • Antipsychotic drugs
  • Effectiveness
  • Longitudinal
  • Randomized clinical trial
  • Schizophrenia

ASJC Scopus subject areas

  • Psychiatry and Mental health

Cite this

The National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project : Schizophrenia trial design and protocol development. / Stroup, T. Scott; McEvoy, Joseph Patrick; Swartz, Marvin S.; Byerly, Matthew J.; Glick, Ira D.; Canive, Jose M.; McGee, Mark F.; Simpson, George M.; Stevens, Michael C.; Lieberman, Jeffrey A.

In: Schizophrenia Bulletin, Vol. 29, No. 1, 01.01.2003, p. 15-31.

Research output: Contribution to journalReview article

Stroup, T. Scott ; McEvoy, Joseph Patrick ; Swartz, Marvin S. ; Byerly, Matthew J. ; Glick, Ira D. ; Canive, Jose M. ; McGee, Mark F. ; Simpson, George M. ; Stevens, Michael C. ; Lieberman, Jeffrey A. / The National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project : Schizophrenia trial design and protocol development. In: Schizophrenia Bulletin. 2003 ; Vol. 29, No. 1. pp. 15-31.
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