{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T17:21:01Z","timestamp":1759339261020,"version":"3.37.3"},"reference-count":22,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2018,7,2]],"date-time":"2018-07-02T00:00:00Z","timestamp":1530489600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"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":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Psychiatry Clin Neurosci"],"published-print":{"date-parts":[[2018,9]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>The purpose of this study was to evaluate the safety and efficacy of aripiprazole in adolescents with schizophrenia (SCZ) in Japan.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In a 6\u2010week, randomized, double\u2010blind, dose\u2010comparison study, adolescents (aged 13\u201317 years) with SCZ were randomized to receive aripiprazole 2, 6\u201312, or 24\u201330 mg\/day. Patients who completed the 6\u2010week study participated in a 52\u2010week, flexible\u2010dose, open\u2010label extension (OLE) study of aripiprazole (initial dose: 2 mg\/day, maintenance dose: 6\u201324 mg\/day, maximum dose: 30 mg\/day).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In the 6\u2010week study, the percentage of patients completing treatment was: 77.1% (27\/35) for 2 mg\/day; 80.0% (24\/30) for 6\u201312 mg\/day; and 85.4% (35\/41) for 24\u201330 mg\/day. The least squares mean change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to endpoint (primary efficacy endpoint, last observation carried forward) was \u221219.6 for 2 mg\/day, \u221216.5 for 6\u201312 mg\/day, and \u2212 21.6 for 24\u201330 mg\/day. The most common (\u226520% patients in any group) treatment\u2010emergent adverse events (TEAE) were nausea, akathisia, insomnia, and somnolence. Most TEAE were mild or moderate in severity. There were no deaths. In the OLE, 60.3% (41\/68) of patients completed treatment, and the PANSS total score decreased by \u22127.9 from OLE baseline to week 52. The most common (\u226520% patients) TEAE were nasopharyngitis and somnolence. Most TEAE were mild or moderate in severity. There were no deaths.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>These study results suggest that aripiprazole would be safe and well tolerated in both short\u2010 and long\u2010term treatment for adolescents with SCZ in Japan.<\/jats:p><\/jats:sec>","DOI":"10.1111\/pcn.12681","type":"journal-article","created":{"date-parts":[[2018,5,18]],"date-time":"2018-05-18T08:10:36Z","timestamp":1526631036000},"page":"701-712","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Safety and efficacy from a 6\u2010week double\u2010blind study and a 52\u2010week open\u2010label extension of aripiprazole in adolescents with schizophrenia in Japan"],"prefix":"10.1111","volume":"72","author":[{"given":"Hideo","family":"Matsumoto","sequence":"first","affiliation":[{"name":"Department of Psychiatry Tokai University School of Medicine  Kanagawa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jun","family":"Ishigooka","sequence":"additional","affiliation":[{"name":"Institute of CNS Pharmacology  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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