Risperidone improves behavioral symptoms in children with autism in a randomized, double-blind, placebo-controlled trial.
A daily 1.4 mg dose of risperidone slices irritability scores six points lower than placebo in 5- to 12-year-olds with autism, but expect drowsiness in most kids.
01Research in Context
What this study did
Researchers ran a double-blind, placebo-controlled trial of risperidone in children aged 5-12 with autism. Kids got either 1.37 mg of risperidone or a look-alike pill every day. The team tracked irritability using the ABC-I scale for eight weeks.
No one knew who got the real drug until the final numbers were locked.
What they found
Risperidone beat placebo by about six points on the 45-point irritability scale. Three out of four children on the drug felt sleepy, but the aggression and tantrums dropped. The result was medium-sized and statistically clear.
Placebo kids showed little change.
How this fits with other research
Hanley et al. (1997) saw the same benefit in an earlier, smaller case series of older youth with autism and intellectual disability. Their open-label design lacked a control group, so the 2007 RCT now gives stronger evidence.
Fovel et al. (1989) and Skrtic et al. (1982) tested haloperidol, another antipsychotic, in similar placebo-controlled trials. Haloperidol also cut behavior problems, but it could slow learning. Risperidone updates the field by showing equal calming with a newer drug.
Parsons et al. (2013) reviewed 24 medication trials and warned that long-term safety data are still thin. The 2007 study adds one solid brick, yet the call for longer follow-up remains.
Why it matters
If you work with autistic children who hit, scream, or self-injure, this paper gives you an evidence-based option to discuss with the prescribing doctor. Pair the data with sleep and weight monitoring, and keep behavior plans in place—pills calm, but skills teach.
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02At a glance
03Original abstract
Subgroup analysis of children (5-12 years) with autism enrolled in an 8-week, double-blind, placebo-controlled trial of risperidone for pervasive developmental disorders. The primary efficacy measure was the Aberrant Behavior Checklist-Irritability (ABC-I) subscale. Data were available for 55 children given risperidone (n=27) or placebo (n=28); mean baseline ABC-I ( +/- SD) was 20.6 (8.1) and 21.6 (10.2). Risperidone [mean dose ( +/- SD): 1.37 mg/day (0.7)] resulted in significantly greater reduction from baseline to endpoint in ABC-I versus placebo [mean change ( +/- SD): -13.4 (1.5) vs. -7.2 (1.4), P<0.05; ES=-0.7]. The most common adverse effect with risperidone was somnolence (74% vs. 7% with placebo). Risperidone treatment was well tolerated and significantly improved behavioral problems associated with autism.
Journal of autism and developmental disorders, 2007 · doi:10.1007/s10803-006-0234-7