Objective: To evaluate the impact of risperidone on functional impairment in a paediatric sample and to document the range of adverse drug reactions.
Methods: Risperidone treatment in children and adolescents (n = 51) with severe behavioural disturbances was assessed retrospectively to determine clinical response and adverse events. The change in patient functional performance during treatment was assessed using the Royal Alexandra Hospital for Children Measure of Function (MOF) score. Changes in target behaviours (such as severe aggression) were also assessed.
Results: The average duration of follow up was 9 months. Clinical improvement was demonstrated in 76% of the sample. There was a statistically significant improvement in the mean MOF with risperidone therapy (10.61 with 99% confidence interval 6.6-14.6). Risperidone appeared to be particularly useful in patients with autistic spectrum disorders. Twenty-five of the 51 patients (49%) experienced side-effects including sedation (27%), weight gain (20%), anticholinergic (10%) and extrapyramidal (8%) side-effects.
Conclusions: This study suggests that risperidone is an effective agent in severely behaviourally disturbed paediatric patients. However, risperidone use is limited by the high frequency of side-effects. Randomized controlled trial data are required to determine the safety and efficacy of risperidone.