Switching to Ziprasidone in the Clinical Practice Setting: An Open-Label Study

Abstract

Objective: This observational study evaluates the long-term outcome of switching to ziprasidone in patients with schizophrenia in the clinical practice setting. Methods: Patients (208) with schizophrenia who had been switched to ziprasidone monotherapy due to partial response or tolerability problems were followed for 1 year. Efficacy was assessed at baseline and months 1, 3, and 12 with Brief Psychiatric Rating Scale (BPRS), Clinical Global Impression-severity (CGI-S), and CGI-improvement. Quality of life, functionality, and safety measures, including metabolic parameters, were also assessed; 195 subjects comprised the per protocol analysis population. Results: A reduction ≥ 30% in BPRS total score was observed in 42.5% of the subjects. Mean scores of the BPRS (global and positive and negative clusters), CGI-S and CGI-I significantly decreased at endpoint ( p < 0.001). Ziprasidone treatment was also associated with statistically significant improvements in the GAF, WHO-DAS-II, and SF-12. After 1-year follow-up, a mean weight decrease of −1.6 kg ( p < 0.05) was observed. Mean levels of LDL cholesterol and triglycerides also decreased ( p < 0.01) while HDL cholesterol levels increased ( p < 0.05) at endpoint. No significant changes in mean glucose levels at study end were detected. Conclusion: These findings suggest that switching to ziprasidone is effective and well tolerated in patients with schizophrenia requiring a change in antipsychotic medication.