ZIPRASIDONE 40 AND 120 MG DAY IN THE ACUTE EXACERBATION OF SCHIZOPHRENIA AND SCHIZOAFFECTIVE DISORDER - A 4-WEEK PLACEBO-CONTROLLED TRIAL/

A double-blind, placebo-controlled, multicenter study, was performed t o evaluate the efficacy and safety of ziprasidone in 139 patients with an acute exacerbation of schizophrenia or schizoaffective disorder. P atients were randomized to receive ziprasidone 40 mg/day, 120 mg/day o r placebo for 28 days. Ziprasidone 120 mg/day was significantly more e ffective than placebo in improving the BPRS total, CGI-S, BPRS depress ion cluster and BPRS anergia cluster scores (all P < 0.05), Similarly, the percentages of patients classified as responders on the BPRS (gre ater than or equal to 30% reduction) and the CGI improvement (score le ss than or equal to 2) were significantly greater with ziprasidone 120 mg/day compared with placebo (P < 0.05), The number of patients who e xperienced an adverse event was similar in all three treatment groups, and discontinuation due to adverse events was rare (five of 91 zipras idone-treated patients). The most frequently reported adverse events, that were more common in either ziprasidone group than in the placebo group, were dyspepsia, constipation, nausea and abdominal pain. There was a notably low incidence extrapyramidal side-effects (including aka thisia) and postural hypotension and no pattern of laboratory abnormal ities or apparent weight gain. Ziprasidone-treated patients were not c linically different from placebo-treated patients on the Simpson-Angus Rating scale, Barnes Akathisia scale and AIMS assessments. These resu lts indicate that ziprasidone 120 mg/day is effective in the treatment of the positive, negative and affective symptoms of schizophrenia and schizoaffective disorder with a very low side-effect burden.