Risperidone and Aripiprazole in Children with Autism Spectrum Disorder Substantially Improves Core Signs and Symptoms in Combination with Standard Supportive Therapies: A Large, Single-Center, Retrospective Case Series

Abstract Background: There are a number of medications prescribed to address comorbid challenging behaviors in children with autism spectrum disorder (ASD), including risperidone and aripiprazole. This retrospective case series reports the use of these drugs in children aged 2 to 13 years.Methodology: A total of 82 children (mean age, 5 years; 79% male) with ASD treated at the Kids Neuro Clinic and Rehab Center in Dubai between January 2020 and September 2021 were included in this retrospective case series. All patients had comorbid challenging behaviors that were resistant to standard supportive therapies alone and warranted pharmacological intervention. The Childhood Autism Rating Scale – 2nd Edition Standard form (CARS2-ST) and the Clinical Global Impression (CGI) – Severity (CGI-S) and CGI – Improvement (CGI-I) scales were used to assess the severity of ASD at baseline and to monitor response to treatment with risperidone or aripiprazole. Results: Besides the expected improvement in comorbid challenging behaviors, 79/82 patients (96%) attained a CGI-I score of 2 or 1 following treatment, and 35/82 patients (43%) achieved both a CGI-I score of 1 and minimal-to-no symptoms as per the CARS2-ST test, with complete resolution of their ASD signs and symptoms. The differences in the overall mean CARS2-ST and CGI-S scores pre- and post-treatment were statistically significant (Z = −7.86, P < 0.0001 for both), with pre- and post-treatment mean values of 42 and 23 for CARS2-ST, respectively, and 6 and 2 for CGI-S, respectively. The main side effects were asymptomatic elevated prolactin (n=12) and excessive weight gain (n=2).Conclusion: When combined with standard supportive therapies, chronic treatment with antipsychotic medications, either with or without medications for attention deficit hyperactivity disorder, was well tolerated and effective in the treatment of ASD core symptoms and comorbid behaviors in young children. Double-blind, placebo-controlled clinical trials are needed to verify these findings.