{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T07:22:50Z","timestamp":1773386570805,"version":"3.50.1"},"reference-count":32,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2019,12,8]],"date-time":"2019-12-08T00:00:00Z","timestamp":1575763200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100005612","name":"Shionogi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100005612","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007343","name":"Shire","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007343","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Neuropsychopharm Rep"],"published-print":{"date-parts":[[2020,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims<\/jats:title><jats:p>As an extension of a phase 2\/3 study evaluating the efficacy and safety of lisdexamfetamine dimesylate (LDX) 30, 50, or 70\u00a0mg\/d for 4\u00a0weeks in Japanese patients aged 6\u201017\u00a0years with attention\u2010deficit\/hyperactivity disorder (ADHD), this study evaluated its long\u2010term safety and efficacy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This was a multicenter, open\u2010label study of LDX for 53\u00a0weeks. Safety was assessed by regular medical examination for treatment\u2010emergent adverse events (TEAEs); regular recording of body weight, vital signs, and laboratory test values; and completion of dependence questionnaires. Efficacy was assessed using Japanese versions of the ADHD\u2010Rating Scale\u2010IV (ADHD\u2010RS\u2010IV) and Conners' 3rd edition Parent Rating Scale (Conners 3); plus Clinical Global Impression\u2010Improvement (CGI\u2010I), Clinical Global Impression\u2010Severity, and Parent Global Assessment (PGA) scales.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 132 enrolled patients, 104 completed the trial. Most frequent treatment\u2010related TEAEs were decreased appetite (73.5%), initial insomnia (39.4%), and weight decrease (22.0%). Most TEAEs were mild (82.6% of patients). There were no serious or severe TEAEs or deaths. No treatment\u2010related TEAEs were associated with blood pressure or pulse rate, and no patient had a QTcF interval &gt;500\u00a0ms. Statistically significant improvement from baseline to week 53 was observed in the mean ADHD\u2010Rating Scale\u2010IV total score and mean Conners 3 subscale scores. Most patients showed improvement on the CGI\u2010I (78%) and PGA (76.5%) scales.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>No significant safety issues were observed with LDX 30, 50, or 70\u00a0mg\/d administered for 1\u00a0year in Japanese children and adolescents with ADHD. LDX was associated with long\u2010term reductions in ADHD symptoms and severity.<\/jats:p><\/jats:sec>","DOI":"10.1002\/npr2.12091","type":"journal-article","created":{"date-parts":[[2019,12,9]],"date-time":"2019-12-09T07:24:35Z","timestamp":1575876275000},"page":"52-62","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Long\u2010term study of lisdexamfetamine dimesylate in Japanese children and adolescents with attention\u2010deficit\/hyperactivity disorder"],"prefix":"10.1002","volume":"40","author":[{"given":"Hironobu","family":"Ichikawa","sequence":"first","affiliation":[{"name":"Japan Developmental Disorders Network Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tasuku","family":"Miyajima","sequence":"additional","affiliation":[{"name":"Department of Education for Childcare Tokyo Kasei University Saitama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yushiro","family":"Yamashita","sequence":"additional","affiliation":[{"name":"Department of Pediatrics and Child Health Kurume University School of Medicine Fukuoka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masakazu","family":"Fujiwara","sequence":"additional","affiliation":[{"name":"Biostatistics Center Shionogi &amp; Co., Ltd Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akimasa","family":"Fukushi","sequence":"additional","affiliation":[{"name":"Clinical Research I Division Clinical Research Department Shionogi &amp; Co., Ltd Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuhiko","family":"Saito","sequence":"additional","affiliation":[{"name":"Aiiku Counselling Office Aiiku Research Institute Imperial Gift Foundation Boshi\u2010Aiiku\u2010Kai Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,12,8]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2014-3482"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild-2016-310487"},{"key":"e_1_2_13_4_1","unstructured":"Special Needs Education Division the Elementary and Secondary Education Bureau JapaneseMinistry of Education Culture Sports Science and Technology.Results of research about children\/students with probable developmental disabilities who need special educational support in the regular class: December 5 2012 [cited 2018 May 31]. 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