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Comparative Effectiveness of Therapies for Children With Autism Spectrum Disorders

Slide: 24 of 36

Outcomes of Risperidone and Aripiprazole for Hyperactivity/Noncompliance

This review included four RCTs that compared risperidone to placebo and two RCTs that compared aripiprazole to placebo.

Risperidone: Two of the four RCTs of risperidone focused on challenging behavior as their primary outcomes and included a combined total of 180 subjects. Both studies used a graduated-dose titration design over 8 weeks; the average risperidone dose ranged from 1.5–1.8 mg per day. In these two studies, baseline ratings of hyperactivity and noncompliance were measured with the Hyperactivity Subscale of the Aberrant Behavior Checklist-Community Version (ABC-C) and were similar across the risperidone (27.3–31.8) and placebo (30.9–32.3) arms. Decreases in ABC-C Hyperactivity Subscale were significantly greater for the risperidone arms in both studies (14.8–14.9) when compared with the placebo arms (4.7–7.4).

Aripiprazole: Each of the two aripiprazole RCTs indexed a primary outcome of challenging behavior by the ABC-C Hyperactivity Subscale and together included 213 subjects in the aripiprazole arm and 103 subjects in the placebo arms. The study by Marcus et al. (2009) was a fixed-dose design with one placebo arm and three arms corresponding to 5, 10, and 15 mg per day of aripiprazole. Only the results for the 15 mg/day versus placebo arm are shown in the figure in this slide, although improvements in challenging behaviors were noted for all three aripiprazole arms. An increased response with an increased dose was observed. In both RCTs, baseline ratings of hyperactivity/noncompliance were similar across the aripiprazole arms (ABC-C Hyperactivity Subscale 32.2–34.1) and the placebo arms (ABC-C Hyperactivity Subscale 31.0–34.7). Decreases in ABC-C Hyperactivity Subscale scores were significantly greater for the aripiprazole arms in both studies, with improvements of 12.7–16.3 as opposed to 2.8–7.7 for the placebo arms.