A comparative study of risperidone and aripiprazole in attention deficit hyperactivity disorder in children under six years old: A randomized double-blind study

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.