{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,13]],"date-time":"2026-01-13T07:57:04Z","timestamp":1768291024821,"version":"3.49.0"},"reference-count":43,"publisher":"MDPI AG","issue":"12","license":[{"start":{"date-parts":[[2023,11,24]],"date-time":"2023-11-24T00:00:00Z","timestamp":1700784000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Suzhou Health Talents Training Project","award":["GSWS2019002"],"award-info":[{"award-number":["GSWS2019002"]}]},{"name":"Suzhou Health Talents Training Project","award":["GSKY20210207"],"award-info":[{"award-number":["GSKY20210207"]}]},{"DOI":"10.13039\/501100007289","name":"Gusu Project, Gusu College, Nanjing Medical University","doi-asserted-by":"publisher","award":["GSWS2019002"],"award-info":[{"award-number":["GSWS2019002"]}],"id":[{"id":"10.13039\/501100007289","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100007289","name":"Gusu Project, Gusu College, Nanjing Medical University","doi-asserted-by":"publisher","award":["GSKY20210207"],"award-info":[{"award-number":["GSKY20210207"]}],"id":[{"id":"10.13039\/501100007289","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brain Sciences"],"abstract":"<jats:p>Background: SPN-812 has been approved for attention-deficit\/hyperactivity disorder (ADHD) treatment in children and adolescents. Objective: We aimed to analyze the efficacy and safety of different doses of SPN-812 for ADHD pediatric patients of different ages, verify its clinical efficacy, and evaluate its safety. Methods: Up until 30 August 2023, randomized controlled trials (RCTs) were searched in EMBASE, MEDLINE, the Cochrane Library, and clinicaltrials.gov to evaluate different doses of SPN-812 and a placebo. Results: We pooled 1619 patients from five RCTs with a duration of 6\u20138 weeks. Patients (6\u201317 years old) in SPN-812 (100, 200, and 400 mg\/d) groups were superior to the control group in all efficacy outcomes with lower attention-deficit\/hyperactivity disorder rating scale-5 (ADHD-RS-5), Conners 3-parent short form composite T score (Conners 3-PS), Weiss functional impairment rating scale-parent (WFIRS-P), and increased clinical global impression-improvement (CGI-I) score (both p &lt; 0.05). At the same time, only SPN-812 300 mg\/d did not show a significantly high risk of the adverse events (AEs) such as somnolence and decreased appetite (p = 0.09). There was no significant difference between placebo and SPN-812 groups (100, 200, and 400 mg\/d) in serious adverse events (SAEs) such as syncope. The subgroup analyses showed that, both in children and adolescents subgroups, SPN-812 showed better efficacy than the placebo. The two age subgroups showed a significantly higher risk of AEs and an insignificant risk of SAEs than the placebo. Conclusion: At present, SPN-812 (100, 200, and 400 mg\/d) is superior to the corresponding control in efficacy measures. However, the safety problem cannot be ignored.<\/jats:p>","DOI":"10.3390\/brainsci13121627","type":"journal-article","created":{"date-parts":[[2023,11,24]],"date-time":"2023-11-24T03:43:59Z","timestamp":1700797439000},"page":"1627","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Efficacy and Safety of SPN-812 (Extended-Release Viloxazine) in Children and Adolescents with Attention-Deficit\/Hyperactivity Disorder: A Systematic Review and Meta-Analysis"],"prefix":"10.3390","volume":"13","author":[{"given":"Xin","family":"Tan","sequence":"first","affiliation":[{"name":"Department of Neurology, The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital, Suzhou 215000, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuejuan","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Children\u2019s Hospital of Wujiang District, Children\u2019s Hospital of Soochow University, Suzhou 215025, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shixin","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery& Brain and Nerve Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou 215006, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiaxuan","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery& Brain and Nerve Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou 215006, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chunxia","family":"Hu","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Children\u2019s Hospital of Wujiang District, Children\u2019s Hospital of Soochow University, Suzhou 215025, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7517-7036","authenticated-orcid":false,"given":"Zhouqing","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery& Brain and Nerve Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou 215006, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Qingzhang","family":"Cheng","sequence":"additional","affiliation":[{"name":"Department of Neurology, The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou Municipal Hospital, Suzhou 215000, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7342-0845","authenticated-orcid":false,"given":"Zhong","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery& Brain and Nerve Research Laboratory, The First Affiliated Hospital of Soochow University, Suzhou 215006, China"},{"name":"Department of Neurosurgery, The First Affiliated Hospital of Soochow University, Suzhou 215006, China"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2023,11,24]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"727","DOI":"10.1016\/S2215-0366(18)30269-4","article-title":"Comparative efficacy and tolerability of medications for attention-deficit hyperactivity disorder in children, adolescents, and adults: A systematic review and network meta-analysis","volume":"5","author":"Cortese","year":"2018","journal-title":"Lancet Psychiatry"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"204","DOI":"10.1192\/bjp.bp.107.048827","article-title":"Prevalence and correlates of adult attention-deficit hyperactivity disorder: Meta-analysis","volume":"194","author":"Simon","year":"2009","journal-title":"Br. 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