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.
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.
Division of Child Neurology and Psychiatry, Department of Pediatrics, University of Messina, Policlinico Universitario G. Martino, Via Consolare Valeria 1, 98125, Messina, Italy. mlamberti@unime.it.|Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy. mlamberti@unime.it.
Marco
M
Lamberti
Institution of Clinical Physiology, CNR, Messina, Italy.
Rosamaria
R
Siracusano
Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
Domenico
D
Italiano
Division of Child Neurology and Psychiatry, Department of Pediatrics, University of Messina, Policlinico Universitario G. Martino, Via Consolare Valeria 1, 98125, Messina, Italy.
Norma
N
Alosi
Division of Child Neurology and Psychiatry, Department of Pediatrics, University of Messina, Policlinico Universitario G. Martino, Via Consolare Valeria 1, 98125, Messina, Italy.
Francesca
F
Cucinotta
Division of Child Neurology and Psychiatry, Department of Pediatrics, University of Messina, Policlinico Universitario G. Martino, Via Consolare Valeria 1, 98125, Messina, Italy.
Gabriella
G
Di Rosa
Division of Child Neurology and Psychiatry, Department of Pediatrics, University of Messina, Policlinico Universitario G. Martino, Via Consolare Valeria 1, 98125, Messina, Italy.
Eva
E
Germanò
Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
Edoardo
E
Spina
Division of Child Neurology and Psychiatry, Department of Pediatrics, University of Messina, Policlinico Universitario G. Martino, Via Consolare Valeria 1, 98125, Messina, Italy.
Antonella
A
Gagliano
D014150:Antipsychotic Agents / Q000627:therapeutic use; D000068180:Aripiprazole / Q000627:therapeutic use*; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000067877:Autism Spectrum Disorder / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D008297:Male; D010865:Pilot Projects; D018967:Risperidone / Q000627:therapeutic use*
D014150:Antipsychotic Agents; D000068180:Aripiprazole; D018967:Risperidone