Post-marketing surveillance on the efficacy, safety and tolerability of Ziprasidone(Zeldox) in the treatment of schizophrenia and schizoaffective disorder

ABSTRACT

Objectives: The primary objective of this trial was to evaluate the overall safety of oral ziprasidone among Filipinos diagnosed with acute exacerbation of schizophrenia and schizoaffective disorder based on the incidence of adverse events. Secondarily, the study was undertaken to evaluate the efficacy of oral ziprasidone based on the Clinical Global Impression (CGI)- Severity (S) and CGI-Improvement. Methods: Four thousand three hundred forty patients diagnosed with schizophrenia and schizoaffective disorders were to received Ziprasidone oral capsules. This was an open-label, multicenter study. The minimum expected duration of exposure to ziprasidone treatment for an individual subject was at least 2 weeks. Safety was based on the reported adverse event. Primary efficacy measures included the changes in CGI-S Score and weight and the CGI-I score at the end of treatment. Results: Among the 4,340 patients enrolled in the study, four thousand one hundred twenty seven (95%) patients completed the treatment, with 2% of the patients discontinue due to adverse events. 18% of the patients experienced adverse events which were mild to moderate in severity. Somnolence (3.2%) and dizziness (1.4%) were the most frequently reported adverse events. Conclusions: Ziprasidone is a safe and effective treatment for Filipino patients diagnosed with acute exacerbation of schizoaffective disorder.