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Background: Stimulants are not very effective on attention deficit hyperactivity disorder (ADHD) children under 6 years old. The most common medication that is used in this range of age is Risperidone. Evaluating the safety and efficacy of Aripiprazole versus Risperidone for treating children under 6 years suffering from ADHD was the aim of this study. Methods: During this double-blind clinical trial, 34 children aged 3-6 years who were diagnosed with ADHD, received treatments with Aripiprazole or Risperidone randomly for 12 weeks. Follow-up measures comprised, CGAS, the ADHD-RS, CPRS and side effect checklist. Results: The findings revealed that 20 patients in Risperidone group (including 13 boys and 7 girls) and 20 patients in Aripiprazole group (including 13 boys and 7 girls) had at least one follow-up examination. After 12 weeks of the study, both medications showed distinct improvements in ADHD RS (P < 0.001), CPRS (P < 0.001) and CGAS (P < 0.001) scores. The statistic difference between them was not significantly different. The most common side effects in Risperidone group were reported to be panic (20%), nausea and vomiting (20%), while in Aripiprazole they were reported to be increased appetite (25%) and somnolence (15%). Conclusions: The findings revealed that both Risperidone and Aripiprazole are effective in treating ADHD children under 6 years old and there was no significant difference between the two drugs. Children can tolerate them well. Aripiprazole effect on children showed itself earlier compared to Risperidone.

iranian journal of pediatrics

A Comparative Study of Risperidone and Aripiprazole in Attention Deficit Hyperactivity Disorder in Children Under Six Years Old: A Randomized Double-Blind Study