{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T20:13:38Z","timestamp":1777493618571,"version":"3.51.4"},"reference-count":39,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2020,1,30]],"date-time":"2020-01-30T00:00:00Z","timestamp":1580342400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2020,1,30]],"date-time":"2020-01-30T00:00:00Z","timestamp":1580342400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Child and Adolescent Psychopharmacology"],"published-print":{"date-parts":[[2020,2]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To further define the efficacy and safety profiles of lisdexamfetamine dimesylate (LDX) in Japanese pediatric patients with attention-deficit\/hyperactivity disorder (ADHD).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>This was a multicenter, randomized, double-blind, placebo-controlled study of LDX 30, 50, or 70\u2009mg\/day for 4 weeks in 76 patients 6\u201317 years of age with ADHD in Japan. The primary efficacy endpoint was the change in the ADHD Rating Scale-IV (ADHD-RS-IV) total score from baseline to 4 weeks. Secondary efficacy endpoints were: Conners' Third Edition (Japanese version) Parent Rating Scale (Conners 3), Clinical Global Impression-Improvement (CGI-I) scale, and Parent Global Assessment (PGA) scale.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Change in the ADHD-RS-IV total score from baseline to 4 weeks was significantly greater (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009&lt;\u20090.0001) in all LDX dosage groups versus placebo (30\u2009mg, \u221216.38; 50\u2009mg, \u221218.10; 70\u2009mg, \u221216.47; placebo, \u22122.78). At all time points, improvements (decreases) in the ADHD-RS-IV total score were significantly greater in all LDX groups versus placebo. At weeks 3 and 4, improvements from baseline in Conners 3 inattention plus hyperactivity\/impulsivity subscale scores were significantly greater (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009\u2264\u20090.0082) for all LDX dosages versus placebo. At week 4, the proportion of LDX-treated patients \u201cmuch improved\u201d or \u201cvery much improved\u201d was 61%\u201371% on the CGI-I scale (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009\u2264\u20090.0019) and 56%\u201365% on the PGA scale (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      \u2009\u2264\u20090.0170). LDX was generally well tolerated. The most frequent treatment-emergent adverse events (AEs) were decreased appetite, headache, and initial insomnia. No severe\/serious AEs occurred, and no AEs specific to Japanese patients were evident.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>The superiority of LDX 30, 50, and 70\u2009mg\/day over placebo was confirmed in Japanese pediatric patients with ADHD, and no major safety or tolerability concerns were identified.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/cap.2019.0076","type":"journal-article","created":{"date-parts":[[2019,11,13]],"date-time":"2019-11-13T10:40:02Z","timestamp":1573641602000},"page":"21-31","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":8,"title":["Phase II\/III Study of Lisdexamfetamine Dimesylate in Japanese Pediatric Patients with Attention-Deficit\/Hyperactivity Disorder"],"prefix":"10.1177","volume":"30","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 Department, Shionogi &amp; Co., Ltd, Osaka, Japan."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuhiko","family":"Saito","sequence":"additional","affiliation":[{"name":"Aiiku Counseling Office, Aiiku Research Institute, Imperial Gift Foundation Boshi-Aiiku-Kai, Tokyo, Japan."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2020,1,30]]},"reference":[{"key":"e_1_3_5_2_1","doi-asserted-by":"publisher","DOI":"10.1089\/cap.2016.0121"},{"key":"e_1_3_5_3_1","volume-title":"American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders","year":"2013","unstructured":"American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, 5th ed. 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