{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,26]],"date-time":"2026-07-26T19:03:44Z","timestamp":1785092624679,"version":"3.55.0"},"reference-count":26,"publisher":"SAGE Publications","issue":"2","license":[{"start":{"date-parts":[[2019,3,29]],"date-time":"2019-03-29T00:00:00Z","timestamp":1553817600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015235","name":"Supernus Pharmaceuticals, Inc.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100015235","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J Atten Disord"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:p>Objective: The objective of this study is to evaluate efficacy and safety of SPN-812 (extended-release viloxazine) for ADHD in children aged 6 to 12 years. Method: In an 8-week study, 222 participants were randomized to placebo or SPN-812 100, 200, 300, or 400 mg\/day. Measurements included ADHD Rating Scale (RS)-IV total score and Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I) scores. Safety assessments included laboratory and electrocardiogram (ECG) measurements, suicidality monitoring (Columbia-Suicide Severity Rating Scale), and adverse event (AE) reporting. Results: Significant improvements in ADHD-RS-IV total score were observed for 200, 300, and 400 mg dose groups versus placebo ( p &lt; .05; effect size [ES] = 0.547, 0.596, and 0.623). CGI-I score for the 300 mg group and CGI-S score for all SPN-812 groups except for 100 mg improved significantly ( p &lt; .05) versus placebo. The most frequent AEs (\u226515%) were somnolence, headache, and decreased appetite. Conclusion: SPN-812 significantly reduced the severity of ADHD symptoms and was well tolerated. The efficacy and safety of SPN-812 are being investigated in Phase III trials.<\/jats:p>","DOI":"10.1177\/1087054719836159","type":"journal-article","created":{"date-parts":[[2019,3,29]],"date-time":"2019-03-29T09:30:17Z","timestamp":1553851817000},"page":"348-358","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":60,"title":["A Phase II Double-Blind, Placebo-Controlled, Efficacy and Safety Study of SPN-812 (Extended-Release Viloxazine) in Children With ADHD"],"prefix":"10.1177","volume":"24","author":[{"given":"Janet K.","family":"Johnson","sequence":"first","affiliation":[{"name":"Formerly at Supernus Pharmaceuticals, Inc., Rockville, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tesfaye","family":"Liranso","sequence":"additional","affiliation":[{"name":"Supernus Pharmaceuticals, Inc., Rockville, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keith","family":"Saylor","sequence":"additional","affiliation":[{"name":"NeuroScience, Inc., Herndon, VA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriela","family":"Tulloch","sequence":"additional","affiliation":[{"name":"Formerly at Supernus Pharmaceuticals, Inc., Rockville, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toyin","family":"Adewole","sequence":"additional","affiliation":[{"name":"Supernus Pharmaceuticals, Inc., Rockville, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Schwabe","sequence":"additional","affiliation":[{"name":"Supernus Pharmaceuticals, Inc., Rockville, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Azmi","family":"Nasser","sequence":"additional","affiliation":[{"name":"Supernus Pharmaceuticals, Inc., Rockville, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert L.","family":"Findling","sequence":"additional","affiliation":[{"name":"Johns Hopkins University, Baltimore, MD, USA"},{"name":"Kennedy Krieger Institute, Baltimore, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey H.","family":"Newcorn","sequence":"additional","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2019,3,29]]},"reference":[{"key":"bibr1-1087054719836159","doi-asserted-by":"publisher","DOI":"10.4088\/PCC.v03n0204"},{"key":"bibr2-1087054719836159","volume-title":"Diagnostic and Statistical Manual of Mental Disorders","author":"American Psychiatric Association","year":"1994","edition":"4"},{"key":"bibr3-1087054719836159","doi-asserted-by":"publisher","DOI":"10.1176\/appi.books.9780890425596"},{"key":"bibr4-1087054719836159","doi-asserted-by":"publisher","DOI":"10.5863\/1551-6776-21.3.192"},{"issue":"7","key":"bibr5-1087054719836159","first-page":"28","volume":"4","author":"Busner J.","year":"2007","journal-title":"Psychiatry"},{"key":"bibr6-1087054719836159","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0180355"},{"key":"bibr7-1087054719836159","doi-asserted-by":"publisher","DOI":"10.1517\/13543784.2016.1147558"},{"key":"bibr8-1087054719836159","doi-asserted-by":"publisher","DOI":"10.1177\/0269881115602489"},{"key":"bibr9-1087054719836159","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.2014.930437"},{"key":"bibr10-1087054719836159","doi-asserted-by":"publisher","DOI":"10.1007\/s00787-009-0046-3"},{"key":"bibr11-1087054719836159","doi-asserted-by":"publisher","DOI":"10.1080\/15374416.2017.1417860"},{"key":"bibr12-1087054719836159","volume-title":"ECDEU assessment manual for psychopharmacology","author":"Guy W.","year":"1976"},{"key":"bibr13-1087054719836159","doi-asserted-by":"publisher","DOI":"10.1136\/adc.2004.059006"},{"issue":"6","key":"bibr14-1087054719836159","first-page":"231","volume":"44","author":"Hervas A.","year":"2016","journal-title":"Actas Espa\u00f1olas de Psiquiatr\u00eda"},{"key":"bibr15-1087054719836159","doi-asserted-by":"publisher","DOI":"10.1016\/j.euroneuro.2014.09.014"},{"key":"bibr16-1087054719836159","doi-asserted-by":"publisher","DOI":"10.1007\/s40261-015-0336-0"},{"key":"bibr17-1087054719836159","first-page":"1085","volume":"112","author":"Huss M.","year":"2016","journal-title":"Neuropsychiatric Disease and Treatment"},{"key":"bibr18-1087054719836159","volume-title":"Double-blind, randomized, placebo-controlled study of immediate-release viloxazine (SPN-812 IR) as a novel non-stimulant therapy in adults with attention-deficit\/hyperactivity disorder (ADHD)","author":"Johnson J. 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