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Comparative Effectiveness of Therapies for Children With Autism Spectrum Disorders

Slide: 23 of 36

Outcomes of Risperidone and Aripiprazole for Irritability

This review included four randomized clinical trials (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 irritability were measured with the Irritability Subscale of the Aberrant Behavior Checklist–Community Version (ABC-C) and were similar across the risperidone (18.9–26.2) and the placebo (21.2–25.5) arms. Decreases in the ABC-C Irritability Subscale were significantly greater for the risperidone arms in both studies (12.2–14.9) when compared with the placebo arms (3.6–6.5).

Aripiprazole: Each of the two aripiprazole RCTs focused on the primary outcome of challenging behavior indexed by the ABC-C Irritability Subscale. Combined, the trials 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 doses of aripiprazole per day. Only the results for the 15 mg per day versus placebo arm are shown in the figure, although improved outcomes were noted for all three aripiprazole arms and increased response with increased dose was observed. In both RCTs, baseline ratings of irritability were similar across the aripiprazole and the placebo arms (ABC-C Irritability Subscale, 28.0–30.8). Decreases in ABC-C Irritability Subscale scores were significantly greater for the aripiprazole arms in both studies, with improvements of 12.4–14.4  as opposed to 5.0–8.4 for the placebo arm.