By T. Scott Stroup, Jeffrey A. Lieberman
Antipsychotic medicines are a key remedy for schizophrenia and revenues of antipsychotic medicines technique $20 billion in step with yr, with fierce advertising among the makers of the medicine. The U.S. nationwide Institute of psychological health and wellbeing subsidized the scientific Antipsychotic Trials of Intervention Effectiveness (CATIE) venture to supply self sufficient information regarding the comparative effectiveness of medicines. CATIE used to be the most important, longest and such a lot accomplished learn of schizophrenia to this point. carried out lower than rigorous double-blind stipulations, Antipsychotic Trials in Schizophrenia provides the definitive archival result of this landmark examine. The middle of the e-book contains chapters involved in 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 health and wellbeing coverage makers and people operating in pharmaceutical businesses will all locate this to be crucial analyzing.
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Extra resources for Antipsychotic Trials in Schizophrenia: The CATIE Project
Because it would deviate from clinical practice patterns to insist on BID dosing in all cases, we sought to minimize the number of patients required to take their medication BID, and still maintain blinding to the extent possible. Throughout the study, half of the patients randomized to perphenazine, olanzapine, and risperidone were assigned to BID dosing, and half were assigned to QD dosing. All quetiapine and ziprasidone patients were assigned to receive BID dosing unless determined to need only one capsule per day.
Chapter 1: Study design and protocol development process CATIE Schizophrenia Trial Design Phase 2 Phase 3 Participants who discontinue Phase 1 choose either the clozapine or the ziprasidone randomization pathways Participants who discontinue Phase 2 choose one of the following open-label treatments: Phase 1* Double-blind, random treatment assignment Olanzapine Quetiapine 1,460 patients R with schizophrenia R Risperidone Ziprasidone Perphenazine R Clozapine (open-label) Aripiprazole Olanzapine, Quetiapine, or Risperidone Fluphenazine decanoate Olanzapine Ziprasidone Perphenazine Olanzapine, Quetiapine, or Risperidone No one assigned to same drug as in phase 1 Clozapine Quetiapine Risperidone Ziprasidone 2 of the above antipsychotics *Phase 1A: participants with Tardive Dyskinesia (TD) (N = 231) not randomized to perphenazine; Phase 1B: participants who discontinue perphenazine randomized to an atypical (olanzapine, quetiapine, or risperidone) before eligibility for Phase 2.
In general, within the primary and secondary domains, the domain-wise Type I error rate was maintained by identifying one primary analysis of one primary parameter within the domain. All other analyses of the primary parameter, as well as analyses of all other parameters within the domain, were viewed as secondary or supportive. P-values from the primary analysis were considered inferential, and p-values from all secondary analyses were considered descriptive. Descriptive p-values were presented to identify potential treatment differences without drawing conclusions about statistical significance.
Antipsychotic Trials in Schizophrenia: The CATIE Project by T. Scott Stroup, Jeffrey A. Lieberman