Ziprasidone 80 mg/day and 160 mg/day in the acute exacerbation of schizophrenia and schizoaffective disorder: A 6-week placebo-controlled trial

In this double-blind study, patients with an acute exacerbation of schizoph renia or schizoaffective disorder were randomized to receive either ziprasi done 80 mg/day (n = 106) or 160 mg/day (n = 104) or placebo (n = 92),for 6 weeks. Both doses of ziprasidone were statistically significantly more effe ctive than placebo in improving the PANSS total, BPRS total, BPRS core item s, CGI-S, and PANSS negative subscale scores (p <.05). Ziprasidone 160 mg/d ay significantly improved depressive symptoms in patients with clinically s ignificant depression at baseline (MADRS greater than or equal to 14, over- all mean 23.5) (p <.05) as compared with placebo. The percentage of patient s experiencing adverse events was similar in each treatment group, and resu ltant discontinuation tons rare. The most-frequent adverse events associate d with ziprasidone were generally mild dyspepsia, nausea, dizziness, and tr ansient somnolence. Ziprasidone was shown to have a very low liability for inducing movement disorders and weight gain. The results indicate that zipr asidone is effective and well tolerated in the treatment of the positive, n egative, and depressive symptoms of an acute exacerbation of schizophrenia or schizoaffective disorder. (C) 1999 American College of Neuropsychopharma cology. Published by Elsevier Science Inc.