Ziprasidone in the short-term treatment of patients with schizoaffective disorder: Results from two double-blind, placebo-controlled, multicenter studies

This study assessed the efficacy of ziprasidone for the treatment of schizo affective disorder. Data were taken from subsets of patients with schizoaff ective disorder, derived from two separate double-blind, placebo-controlled , parallel-group, multicenter studies. A total of 115 hospitalized patients with an acute episode of schizoaffective disorder were randomly assigned t o receive either fixed oral doses of ziprasidone 40 mg/day (N = 16), 80 mg/ day (N = 18), 120 mg/day (N = 22), 160 mg/day (N = 25), or placebo (N = 34) for 4 to 6 weeks. Mean baseline-to-endpoint changes in Brief Psychiatric R ating Scale (BPRS) total, BPRS Core, Clinical Global Impressions Severity s cale (CGI-S), BPRS Depressive, BPRS Manic, and Montgomery-Asberg Depression Rating Scale total scores were compared between the placebo and ziprasidon e groups. Neurological (Simpson-Angus, Barnes Akathisia, Abnormal Involunta ry Movement Scale [AIMS]) and other side effects were also assessed. Signif icant dose-related improvements on all primary efficacy variables (BPRS tot al, BPRS Core, CGI-S) and for BPRS Manic items were observed with ziprasido ne treatment in a combined analysis of data from both studies (p less than or equal to 0.01). Ziprasidone 160 mg/day was significantly more effective than placebo in improving mean BPRS total, BPRS Core, BPRS Manic, and CGI-S scores (p < 0.05). At 120 mg/day, ziprasidone was significantly more effec tive than placebo in improving mean CGI-S scores (p < 0.05). The incidence of individual adverse events was generally low in all treatment groups and was not dose-related. In addition, no significant differences were observed between baseline-to-endpoint mean changes in Simpson-Angus and AIMS scores with placebo or ziprasidone 40 to 160 mg/day. These results suggest that z iprasidone may have efficacy in the treatment of affective as well as psych otic symptoms of schizoaffective disorder, with a low side-effect burden.