By T. Scott Stroup, Jeffrey A. Lieberman
Antipsychotic drugs are a key remedy for schizophrenia and revenues of antipsychotic medicines method $20 billion in step with yr, with fierce advertising among the makers of the medicine. The U.S. nationwide Institute of psychological wellbeing and fitness backed the scientific Antipsychotic Trials of Intervention Effectiveness (CATIE) undertaking to supply self sufficient information regarding the comparative effectiveness of medicines. CATIE was once the most important, longest and such a lot finished learn of schizophrenia up to now. carried out lower than rigorous double-blind stipulations, Antipsychotic Trials in Schizophrenia provides the definitive archival result of this landmark research. The middle of the ebook involves chapters occupied with particular results that set the CATIE findings in a much broader context. additionally integrated are chapters at the layout, statistical analyses and implications for researchers, clinicians and coverage makers. Psychiatrists, psychiatric researchers, psychological health and wellbeing coverage makers and people operating in pharmaceutical businesses will all locate this to be crucial examining.
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Extra info for Antipsychotic trials in schizophrenia : the CATIE project
11]. After the program was completed, decision-making capacity was again assessed using the MacCAT-CR. Persons who demonstrated adequate decisionmaking capacity after completing the educational program could then enter the study. In order to assess decision-making capacity longitudinally, and to examine the effects of the study medications on decisional capacity, the MacCAT-CR is administered to participants at screening, month 6, month 18, and at each End of Phase visit. Summary This chapter has summarized the rationale, aims, and design of the CATIE schizophrenia trial, its procedures, and its proposed method of evaluating the effectiveness of antipsychotic medications.
The CATIE executive committee took the responsibility to ensure that each statistical analysis reported by the CATIE team was focused on one domain and followed a multiple comparison strategy that addressed the multiple outcomes, multiple phases, and multiple treatment comparisons. The analysis plan for the primary effectiveness outcome was finalized prior to completion of the study. Primary outcome: time to all-cause treatment discontinuation The primary CATIE outcome domain was specified as overall treatment effectiveness.
All ziprasidone comparisons were limited to subjects in the ziprasidone cohort. Therefore, Analytic Set 3, used for comparison of Z vs. O, Q, and R, includes all subjects from stratification group D as well as all subjects in Stratum B, except those who had been randomized to perphenazine. Analytic Set 4, used for comparisons of Z vs. , subjects without TD randomized after ziprasidone was added. Strategies for pair-wise treatment group comparisons The previous section described the analysis data sets used for key treatment group comparisons.