BMC psychiatry
Risperidone for children with attention-deficit/hyperactivity disorder and severe behavioral dysregulation: a randomized placebo-controlled assessor-blinded trial
By Abbasi E, Abdi A and Eskandari R.
Abstract
Background
Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder in childhood, and treatment of children with severe behavioral dysregulation remains challenging. This study evaluated the efficacy and safety of adjunctive risperidone specifically in children with ADHD and clinically significant behavioral dysregulation - including irritability, impulsive aggression, and oppositional symptoms - refractory to behavioral intervention alone.
Methods
In this 48-week randomized, placebo-controlled, assessor-blinded trial, children aged 3-12 years with moderate-to-severe ADHD and significant behavioral dysregulation refractory to behavioral intervention alone were allocated to risperidone (n = 48) or matched placebo (n = 46), both in addition to ongoing structured behavioral intervention and parental psychoeducation. The primary outcome was change in clinician-rated ADHD-RS-IV score from baseline to week 48. Secondary outcomes included parent-rated Conners' scores, Children's Global Assessment Scale (CGAS), treatment response, adverse events, and metabolic parameters.