CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
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Among the Severely Mentally Ill, Who Responds to Ziprasidone?

So far, demographic variables have not consistently been found to predict clinical response to antipsychotics. This study examines some differences in response to ziprasidone, which has been shown to be effective, with a better metabolic side effect profile, but was little used in New York State Hospitals. The aim was to study state hospital patients switched to ziprasidone. The results led to questions about different responses in different groups. Subjects from state hospitals who needed a change of antipsychotic participated in this open-label, 8-week trial of up to 240-mg ziprasidone. Analyses included comparisons of the very different results from two sites. Of the 36 study subjects, 12 terminated early. The 17 outpatients from Buffalo, who were older and on lower doses of antipsychotics pre-study, improved significantly. The 19 inpatients from the Bronx, overall younger and on higher pre-study doses, barely changed. Improvements in PANSS total score were significantly associated with older age, greater baseline severity, and lower doses of antipsychotics pre-study. The subjects improved on metabolic parameters. The results suggest that ziprasidone may be just as effective as previous antipsychotics taken by these severely mentally ill patients, and with fewer metabolic side effects. Note: The study described here includes a dosage of ziprasidone that has not been approved by the U.S. Food and Drug Administration (FDA). The FDA has approved daily doses of ziprasidone no greater than 100 mg PO bid.

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