Switching to ziprasidone in the clinical practice setting: an open-label study.

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 > or = 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.