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Background  The purpose of this study was to evaluate the post-marketing safety and effectiveness of aripiprazole in treating irritability in pediatric patients (6–17 years) with autism spectrum disorder (ASD) in actual clinical sites of Japan.    Methods  In this post-marketing surveillance, patients were enrolled into the multicenter, prospective, non-interventional, observational study for 52 weeks, and were dosed with aripiprazole (1–15 mg/day) under daily clinical settings in Japan.    Results  In 510 patients, the continuation rate of aripiprazole treatment was 84.6% at day 168 (week 24) and 78.1% at day 364 (week 52). Adverse drug reactions (ADRs) occurred in 22.7% of patients ( n  = 116), and the most common ADRs were somnolence (9.4%), followed by weight increased (3.3%). At week 4, the mean change from baseline in the irritability subscale score for the Aberrant Behavior Checklist Japanese version (ABC-J) was − 5.7 ± 6.8 ( n  = 288). Based on multiple regression analysis, comorbid attention deficit and hyperactivity did not affect the ABC-J irritability subscale score at endpoint. At week 24, the mean change from baseline for the Strengths and Difficulties Questionnaire was − 3.3 ± 4.9 ( n  = 215) for the total difficulties score and 0.6 ± 1.7 ( n  = 217) for the prosocial behavior subscale score.    Conclusions  Aripiprazole was well tolerated and effective in the long-term treatment of irritability associated with ASD in Japanese pediatric patients in the real-world clinical practice.    Trial registration  This surveillance was registered with Clinical Trial.gov (no.  NCT03179787 ) on June 7, 2017 (retrospectively registered).    Supplementary Information  The online version contains supplementary material available at 10.1186/s12888-021-03201-6.

bmc psychiatry

Aripiprazole in the real-world treatment for irritability associated with autism spectrum disorder in children and adolescents in Japan: 52-week post-marketing surveillance