Multicenter Studies Of Oral Ziprazidone For The Treatment Of Patients With Schizophrenia And Schizoaffective Disorder [estudos Multicêntricos Da Ziprasidona Oral No Tratamento De Pacientes Com Esquizofrenia Ou Transtorno Esquizoafetivo]

Background: The oral ziprasidone efficacy, safety, and tolerability on Brazilian patients with schizophrenic and schizoaffective disorder were evaluated through two sequential clinical trials. Methods: Prospective open studies. At the first 6-week trial patients received 80 to 160 mg/day of ziprasidone, and were evaluated using the Positive and Negative Symptom Scale (PANSS), Clinical Global Impression-Severity Scale (CGI-S), Intensity Care Questionnaire (ICQ) e Patient Preference Scale (PPS). Safety and tolerability were evaluated by clinical, EKG, and laboratorial analysis, Extrapyramidal Symptom Rating Scale (ESRS), and Barnes Akathisia Scale (BAS). Responsive patients were included on one up to 12-month second trial. Results: 162 patients were analyzed regarding drug efficacy, and 164 regarding tolerability at first clinical trial. From baseline to endpoint treatment decreased PANSS scores from 94.3 to 76.2 (P<.0001). Either scores on CGI-S and ICQ showed significantly reduction. Ziprasidone had the patient's preference (64.8%) compared to the last medication used through the PPS application. Neither, extrapyramidal symptoms or EKG alterations were found. From 106 included patients at the second trial, 86 were analyzed regarding efficacy. The median of treatment duration was 5.6 months, and the mean of PANSS was kept during the evaluation. The adverse events profiles from both studies were similar. Conclusion: Oral ziprasidone is an effective and safe drug for chronic treatment of patients with schizophrenic and schizoaffective disorder. © Copyright Moreira Jr. Editora.644170176Kane, J., Honigfeld, G., Singer, J., Meltzer, H., Clozapine for the treatment-resistant schizophrenic. 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