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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.
There are claims that second-generation antipsychotics produce fewer
extrapyramidal side-effects (EPS) compared with first-generation
To compare the incidence of treatment-emergent EPS between
second-generation antipsychotics and perphenazine in people with
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.
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.
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.
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