{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T13:25:25Z","timestamp":1778678725633,"version":"3.51.4"},"reference-count":19,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2017,11,8]],"date-time":"2017-11-08T00:00:00Z","timestamp":1510099200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100007132","name":"Otsuka Pharmaceutical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100007132","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Psychiatry Clin Neurosci"],"published-print":{"date-parts":[[2018,2]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>The purpose of this study was to evaluate the long\u2010term safety and efficacy of aripiprazole in treating irritability in pediatric patients (6\u201317\u2009years) with autistic disorder (AD) in Japan.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this open\u2010label extension study, patients who had completed a previous randomized, double\u2010blind, placebo\u2010controlled 8\u2010week study were enrolled and were flexibly dosed with aripiprazole (1\u201315\u2009mg\/day) until the new indication of irritability in pediatric autism spectrum disorder was approved in Japan.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Seventy (81%) out of 86 enrolled patients completed week\u201048 assessments. The mean duration of treatment was 694.9\u2009days. The mean daily dose of aripiprazole over the treatment period was 7.2\u2009mg and the mean of the final dose was 8.5\u2009mg. The most common treatment\u2010emergent adverse events (TEAE; \u226520%) included nasopharyngitis, somnolence, influenza, and increased weight. The majority of these TEAE were mild or moderate in severity, and there were no deaths, and no clinically relevant findings in laboratory values except prolactin decrease, vital signs, height, or ECG parameters. At week 48 (observed case), the mean change from baseline in the Irritability subscale score for the Aberrant Behavior Checklist Japanese Version was \u22126.3 in prior placebo patients and \u22122.6 in prior aripiprazole patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Aripiprazole was generally safe, well tolerated, and effective in the long\u2010term treatment of irritability associated with AD in Japanese pediatric patients.<\/jats:p><\/jats:sec>","DOI":"10.1111\/pcn.12607","type":"journal-article","created":{"date-parts":[[2017,9,23]],"date-time":"2017-09-23T12:16:37Z","timestamp":1506168997000},"page":"84-94","source":"Crossref","is-referenced-by-count":20,"title":["An open\u2010label extension long\u2010term study of the safety and efficacy of aripiprazole for irritability in children and adolescents with autistic disorder in Japan"],"prefix":"10.1111","volume":"72","author":[{"given":"Hironobu","family":"Ichikawa","sequence":"first","affiliation":[{"name":"Tokyo Metropolitan Children's Medical Center  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michio","family":"Hiratani","sequence":"additional","affiliation":[{"name":"Hiratani Clinic for Developmental Disorders of Children  Fukui Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akihiro","family":"Yasuhara","sequence":"additional","affiliation":[{"name":"Yasuhara Children's Clinic  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noa","family":"Tsujii","sequence":"additional","affiliation":[{"name":"Department of Neuropsychiatry Kindai University Faculty of Medicine  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takashi","family":"Oshimo","sequence":"additional","affiliation":[{"name":"Yoyogi\u2010no\u2010Mori Mental Clinic  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroaki","family":"Ono","sequence":"additional","affiliation":[{"name":"Headquarters of Clinical Development Otsuka Pharmaceutical Co., Ltd.  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