By T. Scott Stroup, Jeffrey A. Lieberman
Antipsychotic medicines are a key therapy for schizophrenia and revenues of antipsychotic medicines process $20 billion in step with 12 months, with fierce advertising among the makers of the medicine. The U.S. nationwide Institute of psychological well-being subsidized the scientific Antipsychotic Trials of Intervention Effectiveness (CATIE) undertaking to supply self reliant information regarding the comparative effectiveness of medicines. CATIE was once the biggest, longest and so much entire learn of schizophrenia thus far. performed less than rigorous double-blind stipulations, Antipsychotic Trials in Schizophrenia provides the definitive archival result of this landmark research. The center of the publication involves chapters concerned with particular results that set the CATIE findings in a much broader context. additionally incorporated are chapters at the layout, statistical analyses and implications for researchers, clinicians and coverage makers. Psychiatrists, psychiatric researchers, psychological healthiness coverage makers and people operating in pharmaceutical businesses will all locate this to be crucial analyzing.
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Additional info for Antipsychotic trials in schizophrenia : the CATIE project
In the analysis of such secondary outcomes, the following secondary strategy for treatment group comparisons was implemented. The absence of a ziprasidone cohort effect was evaluated by comparing the outcome measure for the pre- versus post-ziprasidone cohorts of the original four treatment groups. If no differences were found, then all treatment groups and all subjects were included in one analysis. A similar strategy was followed for TD patients and perphenazine. In addition, TD status at baseline was generally included as a covariate in treatment group comparisons.
The study originally started with three atypicals: olanzapine, quetiapine, and risperidone. The fourth, ziprasidone, was not yet approved by the FDA at the beginning of the trial, and was added after 40% of subjects had been enrolled. In addition, due to side effect concerns, subjects with TD were stratified into a subgroup labeled Phase 1A, in which the randomization schedule excluded perphenazine. If the Phase 1/1A treatment was found to be unsatisfactory for any reason including subject decision, subjects could discontinue the first treatment phase and be re-randomized to a new double-blind treatment in Phase 2.
Time to discontinuation would not be an appropriate effectiveness outcome for acute illnesses that can be completely healed within a short time period, or intermittent illnesses with symptoms that come and go. In these cases, subjects who discontinued the drug because it was no longer required would need to be carefully separated from those for whom the drug was ineffective or intolerable. Unfortunately, this scenario is not applicable to schizophrenia, where long-term treatment is required, and where patients frequently stop taking medications for non-compliance or side effects.
Antipsychotic trials in schizophrenia : the CATIE project by T. Scott Stroup, Jeffrey A. Lieberman