Hyo Won KimEun Jin ParkJi Hoon KimVitharon Boon-YasidhiJariya TarugsaAlexis ReyesStella ManaloYoo Sook JoungUniversity of the Philippines ManilaPhilippine Children's Medical CenterUlsan UniversityInje UniversityMahidol UniversityPusan National UniversitySungkyunkwan University2019-08-232019-08-232018-08-01Journal of Child and Adolescent Psychopharmacology. Vol.28, No.6 (2018), 402-40815578992104454632-s2.0-85050262357https://repository.li.mahidol.ac.th/handle/123456789/46492© 2018, Mary Ann Liebert, Inc. Objectives: We investigated the effectiveness and tolerability of aripiprazole in the treatment of irritability in Asian children and adolescents (6-17 years) with autistic disorder in a 12-week, multinational, multicenter, open-label study. Methods: Sixty-seven subjects (10.0 ± 3.1 years old, 52 boys) were enrolled and treated with flexibly dosed aripiprazole for 12 weeks (mean dose, 5.1 ± 2.5 mg; range 2-15 mg). Results: Aripiprazole significantly reduced the mean caregiver-rated scores for the Irritability, Lethargy/Social Withdrawal, Stereotypy, Hyperactivity, and Inappropriate Speech subscales of the Aberrant Behavior Checklist from baseline to week 12 (p < 0.001 for all subscales). Clinician-rated Clinical Global Impression Severity of Illness scale score also improved from baseline through week 12 (p < 0.001). The most common adverse event was weight gain and no serious adverse event related to aripiprazole treatment was noted. Conclusion: Our results suggest that aripiprazole is effective and generally tolerable in the treatment of irritability in Asian children and adolescents with autistic disorder. Further studies with larger sample sizes and longer treatment durations are required.Mahidol UniversityMedicineArticleSCOPUS10.1089/cap.2017.0152