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Head-to-Head Comparison of Aripiprazole and Risperidone in the Treatment of ADHD Symptoms in Children with Autistic Spectrum Disorder and ADHD: A Pilot, Open-Label, Randomized Controlled Study

Abstract

Background

Autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) are frequently overlapping neurodevelopmental disorders. Individuals in whom the disorders are comorbid show more severe impairment because of deficits in the processing of social situations, adaptive functioning, and executive control than individuals with either disorder alone.

Objective

This open-label pilot study aimed to evaluate and compare the efficacy and tolerability of risperidone and aripiprazole for treating ADHD symptoms in patients with both ASD and ADHD over the course of 24 weeks of treatment.

Methods

Patients (n = 44) were randomly assigned to start treatment with risperidone (22 patients) or aripiprazole (22 patients). Children were evaluated before starting treatment (T0), and after 12 weeks (T1) and 24 weeks (T2) of treatment. At each visit, specific psychiatric clinical scales were administered to assess the efficacy of the two drugs.

Results

The mean age was 8.4 ± 2.9 years in the aripiprazole group and 7.8 ± 2.3 years in the risperidone group. A total of 37 children (29 boys and 8 girls) completed the study (18 in the aripiprazole group and 19 in the risperidone group). Aripiprazole and risperidone appeared to have similar benefits in terms of efficacy and tolerability, although there were slight differences between the two drugs. Both groups showed a significant improvement in ADHD symptoms after 24 weeks of treatment (ADHD Rating Scale, Conners Parent Rating Scale–Hyperactivity, and Clinical Global Improvement–Severity Scale). No significant difference between the two drugs on any parameters at 24 weeks were found. Prolactin levels were decreased in the aripiprazole group. Both drugs were well tolerated, with no serious adverse events detected.

Conclusions

Our study confirms the efficacy of both aripiprazole and risperidone in ameliorating ADHD symptoms of children also presenting with ASD.

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Correspondence to Marco Lamberti.

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The material is original, has not been published except in abstract form, and is not being considered for publication elsewhere, including publicly accessible websites or e-print servers. All authors have read the manuscript and approve its submission. All research has been conducted adhering to the recommendations contained in the Declaration of Helsinki, and it complies with the International Guiding Principles that regulate research on human participants and/or animals.

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No sources of funding were used to conduct this study of prepare this manuscript.

Conflict of interest

ML, RS, DI, NA, FC, GDR, and EG have no conflicts of interest that are directly relevant to the content of this study. ES has acted as a speaker for AstraZeneca, Lundbeck, Bristol-Meyers Squibb, Eli Lilly and Company, and Janssen-Cilag. AG has acted as a speaker for Shire.

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M. Lamberti and R. Siracusano are joint first authors.

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Lamberti, M., Siracusano, R., Italiano, D. et al. Head-to-Head Comparison of Aripiprazole and Risperidone in the Treatment of ADHD Symptoms in Children with Autistic Spectrum Disorder and ADHD: A Pilot, Open-Label, Randomized Controlled Study. Pediatr Drugs 18, 319–329 (2016). https://doi.org/10.1007/s40272-016-0183-3

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Keywords

  • Autism Spectrum Disorder
  • Autism Spectrum Disorder
  • Risperidone
  • Aripiprazole
  • ADHD Symptom