Korean J Psychopharmacol.  2011 Apr;22(2):73-79.

The Safety and Efficacy of Ziprasidone: Post-Marketing Surveillance Study in Korea

• Kim SN
• Kim E
• Hwang JY
• Kwon JS

Abstract

OBJECTIVE
The aim of this study was to observe the safety and efficacy of ziprasidone in the usual care setting in patients with schizophrenia or acute manic or mixed episodes associated with bipolar disorder.
METHODS
A total of 3,391 patients who were treated with ziprasidone were enrolled from 108 centers in Korea. Differences in the clinical global impression of severity and clinical global impression of improvement (CGI-I) were measured after 8+/-1 weeks administration of ziprasidone. Adverse events were observed in all subjects who were administered ziprasidone at least once. In 330 patients, the change of weight was evaluated.
RESULTS
Ziprasidone was effective for most of schizophrenia and acute manic or mixed episodes associated with bipolar disorder patients. CGI-I score was improved in 84.8% of PP subjects. Of the subjects who did not complete the study, sixty-four (1.9%) subjects discontinued treatment due to adverse events. The most common adverse events were akathisia, somnolence, extrapyramidal symptoms and insomnia. In total, 6 serious adverse events were reported in 2 subjects, including psychotic disorder and suicidal attempt. Mean 0.9 kg of weight loss was observed.
CONCLUSION
Ziprasidone was effective, safe and generally well tolerated for schizophrenia or acute manic or mixed episodes associated with bipolar disorder patients in Korea.

Keyword

Ziprasidone; Efficacy; Tolerability; Adverse event; Schizophrenia; Bipolar disorder

MeSH Terms

Bipolar Disorder
Humans
Korea
Piperazines
Psychomotor Agitation
Psychotic Disorders
Schizophrenia
Sleep Initiation and Maintenance Disorders
Thiazoles
Weight Loss
Piperazines
Thiazoles