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7 results

  • Chapter 9 - Extrapyramidal side effects
  • Edited by T. Scott Stroup, Columbia University, New York, Jeffrey A. Lieberman, Columbia University, New York
  • Book: Antipsychotic Trials in Schizophrenia
  • Published online: 03 May 2010
  • Print publication: 01 April 2010, pp 156-172
  • View abstract

    Summary

    The CATIE (Clinical Antipsychotic Trials of Intervention Effectiveness) schizophrenia study sought to compare the effectiveness and cost-effectiveness of four second-generation antipsychotics and one first-generation antipsychotic in the treatment of schizophrenia. This study design posed several challenges for statistical analysis. The authors describe the stratified Phase 1/1A randomization, and explain the steps for comparing treatment groups within the stratified randomization structure. They describe strategies to perform treatment group comparisons that control the inflation of Type 1 error due to multiple pair-wise testing, and focus on the evaluation of multiple outcomes. The authors examine the advantages of using all-cause treatment discontinuation as the primary effectiveness outcome and the specific statistical issues for its analysis, and address the impact of missing data due to phase discontinuation on analysis of the secondary outcomes. The authors contrast the statistical methods employed to address this issue, and consider further methods.
  • Extrapyramidal side-effects of antipsychotics in a randomised trial
  • Del D. Miller, Stanley N. Caroff, Sonia M. Davis, Robert A. Rosenheck, Joseph P. McEvoy, Bruce L. Saltz, Silvana Riggio, Miranda H. Chakos, Marvin S. Swartz, Richard S.E. Keefe, T. Scott Stroup, Jeffrey A. Lieberman, for the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Investigators
  • Journal: The British Journal of Psychiatry / Volume 193 / Issue 4 / October 2008
  • Published online by Cambridge University Press: 02 January 2018, pp. 279-288
  • Print publication: October 2008
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  • View abstract
    Background

    There are claims that second-generation antipsychotics produce fewer extrapyramidal side-effects (EPS) compared with first-generation drugs.

    Aims

    To compare the incidence of treatment-emergent EPS between second-generation antipsychotics and perphenazine in people with schizophrenia.

    Method

    Incidence analyses integrated data from standardised rating scales and documented use of concomitant medication or treatment discontinuation for EPS events. Mixed model analyses of change in rating scales from baseline were also conducted.

    Results

    There were no significant differences in incidence or change in rating scales for parkinsonism, dystonia, akathisia or tardive dyskinesia when comparing second-generation antipsychotics with perphenazine or comparing between second-generation antipsychotics. Secondary analyses revealed greater rates of concomitant antiparkinsonism medication among individuals on risperidone and lower rates among individuals on quetiapine, and lower rates of discontinuation because of parkinsonism among people on quetiapine and ziprasidone. There was a trend for a greater likelihood of concomitant medication for akathisia among individuals on risperidone and perphenazine.

    Conclusions

    The incidence of treatment-emergent EPS and change in EPS ratings indicated that there are no significant differences between second-generation antipsychotics and perphenazine or between second-generation antipsychotics in people with schizophrenia.