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Effectiveness and Tolerability of Oral Ziprasidone in Psychiatric Inpatients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder: A Multicenter, Prospective, and Naturalistic Study
Objective: This prospective, uncontrolled, and naturalistic study aimed to evaluate the effectiveness and tolerability of oral ziprasidone in psychiatric inpatients with an acute exacerbation of schizophrenia or schizoaffective disorder treated in the clinical practice setting.
Method: Patients had to be at least 18 years old and meet DSM-IV-TR criteria for acute exacerbation of schizophrenia or schizoaffective disorder. Patients were followed until discharge and were evaluated with the Brief Psychiatric Rating Scale (BPRS), Clinical Global Impressions (CGI) scale, Drug Attitude Inventory, and the Scale to Assess Unawareness of Mental Disorder. Ziprasidone dose requirements, dose escalation, discontinuation of treatment, and the use of any concomitant medication including cotreatment with other antipsychotics were established individually according to the clinical judgment of each investigator. The study was conducted from February 2005 to June 2007.
Results: We included a total of 196 patients (intent-to-treat population), 9 (5%) of whom discontinued treatment with ziprasidone (3 because of side effects). The mean (SD) length of stay was 23.4 (34.2) days. The mean (SD) dose at discharge was 186.3 (67.6) mg/day, and the median dose was 160 mg/day (interquartile range, 120-240 mg/day). Response rates at the endpoint, according to BPRS and CGI criteria, were 74% (95% CI = 68% to 80%) and 67% (95% CI = 61% to 74%), respectively. Progressive and statistically significant improvements in all BPRS scores and CGI-Severity of Illness scores were observed from the first week through discharge. All changes from baseline to the study endpoint for BPRS and CGI scores were clinically relevant, with effect sizes greater than 0.80. The insight into illness and the attitude toward medication also improved significantly over the course of the study. Ziprasidone was well tolerated.
Conclusion: Although our results should be interpreted with caution because of the uncontrolled design of our study, they suggest that, in acutely ill inpatients with schizophrenia or schizoaffective disorder, the use of ziprasidone under routine clinical conditions is associated with a rapid and progressive improvement in psychopathologic symptoms and a clinically relevant improvement in insight into their illness.