Efficacy and safety of risperidone and aripiprazole in reducing severity of irritability in children with autism spectrum disorder: A randomized controlled trial.

This study compared two medications (risperidone and aripiprazole) for reducing irritability and challenging behaviours in 72 autistic children aged 6-18. Both medications worked equally well at reducing irritability, improving sleep, and helping with other behaviours. Side effects were similar for both medications, but risperidone increased prolactin hormone levels while aripiprazole decreased them. Parents can discuss with doctors that both medications appear to be equally effective options.

This randomized controlled trial compared risperidone and aripiprazole for treating irritability in 72 children and adolescents (6-18 years) with autism spectrum disorder. Both medications showed comparable efficacy in reducing irritability scores on the Aberrant Behavior Checklist, with no statistically significant differences between groups. Secondary outcomes including autism severity, attention problems, sleep quality, sensory processing, and cognitive function also showed similar improvements in both treatment groups. Adverse event frequencies were comparable, though serum prolactin levels decreased with aripiprazole and increased with risperidone.

The study suggests both medications are equally effective and safe options for managing irritability in autistic children.

Both risperidone and aripiprazole appear to be equally effective first-line options for treating irritability in autistic children. Medication choice may depend on individual factors such as prolactin sensitivity. Clinicians should consider baseline CPRS-R scores and IQ as potential predictors of treatment response when making treatment decisions.

Single-center trial with moderate sample size (n=72) limits generalizability. The study excluded placebo responders after a two-week run-in period, which may affect real-world applicability. No long-term follow-up data provided to assess sustained effects or safety.

Both risperidone and aripiprazole are effective in reducing irritability severity in children with autism spectrum disorder (ASD). However, head-to-head comparison trials between these two drugs are scarce in the literature and have shown conflicting results. This trial compared the efficacy and safety of risperidone and aripiprazole in children and adolescents with ASD, aged 6-18 years. After a two-week placebo trial, placebo responders were excluded.

The remaining participants were randomized into two groups. The outcomes were the change in the irritability subscale of the Aberrant Behavior Checklist (ABC-I), Childhood Autism Rating Scale (CARS2), Conners' Parent Rating Scale-Revised (CPRS-R), Children's Sleep Habits Questionnaire (CSHQ), Sensory Profile-2 (SP-2), cognition and the nature and frequency of treatment-emergent adverse events. Seventy-two patients (36 in each group) were recruited. Changes in the ABC-I score (-13.6 ± 4.3 vs. -12.2 ± 3.9, p = 0.15), ABC total score (-27.5 ± 15.9 vs. -26.8 ± 15.7, p = 0.85), CARS score (-2.9 ± 0.7 vs. -2.7 ± 0.8, p = 0.26), CPRS-R Global Index T-score (-10.63 ± 8.54 vs. -9.61 ± 8.92, p = 0.62), number of patients with significant sensory processing abnormalities (18/36 vs. 18/36, p = 1.0), CSHQ score (-4.6 ± 3.8 vs. -3.9 ± 3.1, p = 0.39), and full-scale IQ (1.9 ± 1.6 vs. 1.8 ± 1.5, p = 0.75) were comparable between groups.

In multivariate regression analysis, CPRS-R Global Index T-score (p = 0.02) and full-scale intelligence quotient (p = 0.03) were independent predictors of changes in the ABC-I score. The frequency of adverse events was similar in both groups. Serum prolactin levels decreased in the aripiprazole group at 12 weeks but increased in the risperidone group. Risperidone and aripiprazole demonstrate comparable efficacy and safety in managing irritability in children and adolescents with ASD.

Trial Registry no: Clinical Trial Registry of India (CTRI/2021/12/038721).