The efficacy and safety of ziprasidone 80 mg/day and 160mg/day in schizophrenia and schizoaffecfive disorder

Abstract

Ziprasidone's high affinity for SHT1A and moderate affinity for D1 receptors suggest significant antipsychotic efficacy with low extrapyramidal side-effect (EPS) liability. This 6-week, double-blind, placebo-controlled study compared the efficacy and safety ofziprasidone in patients with an acute exacerbation of schizophrenia or schizoaffective disorder. After a 3-7 day washout, patients received either ziprasidone 40 mg bid (n= 106); ziprasidone 40 mg bid on days 1-2 then 80 mg bid (n= 104); or placebo (n=92). Both 80 mg and 160 mg/day ziprasidone significantly improved Brief Psychiatric Rating Scale (BPRSd) derived from the Positive and Negative Syndrome Scale (PANSS), BPRSd Core Items, Clinical Global Impression (CGI) Severity, and PANSS Total scores compared with placebo. Improvements in negative symptoms (PANSS Negative Subscale) were significantly greater and improvements in MADRS also greater with both ziprasidone doses compared with placebo. Notable was the low incidence of EPS, akathisia and sexual dysfunction associated with ziprasidone. Discontinuations due to adverse events were infrequent and similar among groups (4.7-9.6%). The results of this study indicate that ziprasidone is an effective and well tolerated antipsychotic, improving positive, negative and affective symptoms without an undue side-effect burden. • The authors thank the Ziprasidone Study Group for participation in this study.