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In this 16-week, double-blind, flexible-dose, placebo-controlled trial, the efficacy and safety of aripiprazole and ziprasidone were compared in patients with schizophrenia. Patients with DSM-III-R (diagnosed with schizophrenia) were randomized to flexible doses of aripiprazole (n = 114) or ziprasidone (n = 111) as required to achieve a PANSS total score of less than or equal to 70 (considered symptomatic) and a CGI-S score of less than or equal to 2 (considered not ill) during the 3-month acute phase. Seventy-eight percent of aripiprazole-treated patients and 78% of ziprasidone-treated patients discontinued the trial because of lack of efficacy. The mean +/- SD change in PANSS total score and CGI-S score at the last visit was -4.3 +/- 11.2 and -0.1 +/- 0.7 in the aripiprazole group, respectively, and -2.4 +/- 10.1 and -0.1 +/- 0.8 in the ziprasidone group, respectively. Aripiprazole was significantly more effective than ziprasidone on the PANSS total score and CGI-S score (Wilcoxon rank sum test; p = 0.0042 and p = 0.037, respectively). These results were consistent across several subgroup analyses. No clinically relevant differences were observed between aripiprazole and ziprasidone in the proportion of patients who showed treatment response. Both treatments were generally well tolerated. Treatment-emergent adverse events were reported in 47% of patients who received aripiprazole and
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