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In the two North American registration trials (Chouinard et al. 1993; Marder and Meibach 1994), a total of 513 patients with chronic schizophrenia were randomly assigned to an 8-week double-blind, fixed-dose, placebo-controlled comparison of risperidone (2, 6, 10, or 16 mg/day) or haloperidol (20 mg/day). Risperidone dosages of 6, 10, and 16 mg/day produced significantly greater reductions, as compared with haloperidol, in each of the five domains of the Positive and Negative Syndrome Scale (PANSS), derived by principal-components analysis (Marder et al. 1997), and significantly higher response rates, defined as a 20% reduction in the PANSS total score. Effect sizes representing the difference in change scores between risperidone (6 mg/day) and haloperidol, although statistically significant, were uniformly small by Cohen's classification system (Cohen 1988): negative symptoms 0.31; positive symptoms 0.26; disorganized thoughts 0.22; uncontrolled hostility/excitement 0.29; and anxiety/depression 0.30 (Table 32–2). Severity of EPS was greater with haloperidol than with risperidone; further statistical analysis suggested that differences in EPS rates did not significantly influence the differences in PANSS subscale ratings (Marder et al. 1997). In fact, risperidone (10 and 16 mg/day) produced improvements in negative symptoms equivalent to those seen with risperidone (6 mg/day), despite increased EPS at the higher dosages of risperidone.

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Table Reference Number
TABLE 32–2. Effect sizes on Positive and Negative Syndrome Scale (PANSS) symptom dimensions: North American trials (N = 513)

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