{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T05:39:11Z","timestamp":1792388351017,"version":"4.4.0"},"reference-count":36,"publisher":"SAGE Publications","issue":"10","license":[{"start":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T00:00:00Z","timestamp":1784678400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T00:00:00Z","timestamp":1784678400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Cingulate Therapeutics, Kansas City, Kansas, United States"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Child and Adolescent Psychopharmacology"],"published-print":{"date-parts":[[2026,12,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>CTx-1301 is the first trimodal dexmethylphenidate formulation developed for the treatment of attention-deficit\/hyperactivity disorder (ADHD).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>In this 5-week, phase 3, fixed-dose study, patients with ADHD aged 6\u201317 years were randomized to once-daily treatment with CTx-1301 (18.75, 25.0, or 37.5 mg) or placebo. CTx-1301 was initiated at 12.5 mg and uptitrated weekly to reach the assigned fixed dose. The primary endpoint was the change from baseline to week 5 in the ADHD Rating Scale, Version 5 (ADHD-RS-5). Secondary efficacy endpoints included Clinical Global Impression\u2013Severity (CGI-S) and \u2013Improvement (CGI-I). Statistical comparisons were evaluated at a Bonferroni-adjusted significance level of 0.017.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      The mean age (\u00b1standard deviation) of the study population (\n                      <jats:italic toggle=\"yes\">N<\/jats:italic>\n                      = 103) was 11.3 \u00b1 3.3 years, and the majority of subjects (60.2%) were male. Treatment with CTx-1301 25.0 or 37.5 mg significantly improved ADHD-RS-5 score from baseline compared with placebo (\n                      <jats:italic toggle=\"yes\">p \u2264<\/jats:italic>\n                      0.011). Exploratory\n                      <jats:italic toggle=\"yes\">post hoc<\/jats:italic>\n                      analyses revealed effect sizes for the comparison of CTx-1301 and placebo ranging from 0.732 (18.75-mg dose) to 1.185 (37.5-mg dose). Improvement in CGI-S was statistically significant for CTx-1301 37.5 mg versus placebo (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      &lt; 0.001). More than 60% of subjects who received CTx-1301 were much to very much improved on CGI-I compared with 18% for placebo. All adverse events were mild or moderate in severity, no new safety signals were identified, and the safety profile was consistent with the known effects of dexmethylphenidate.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>CTx-1301 demonstrated dose-related improvements in signs and symptoms of ADHD, although statistical significance is not consistent across all dose groups. The treatment was well tolerated over 5 weeks in children and adolescents with ADHD. Given the limited sample size and reduced statistical power, these findings should be considered preliminary and require confirmation in larger, adequately powered studies.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10445463261469764","type":"journal-article","created":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T11:36:44Z","timestamp":1784720204000},"page":"607-616","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and Safety of Trimodal Dexmethylphenidate (CTx-1301) in Children and Adolescents with Attention-Deficit\/Hyperactivity Disorder: Results From a Phase 3, Randomized, Double-Blind, Fixed-Dose, Placebo-Controlled Trial"],"prefix":"10.1177","volume":"36","author":[{"given":"Ann","family":"Childress","sequence":"first","affiliation":[{"name":"Center for Psychiatry &amp; Behavioral Medicine, Las Vegas, Nevada, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Brams","sequence":"additional","affiliation":[{"name":"Department of Medical Affairs, Cingulate Therapeutics, Kansas City, Kansas, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael J.","family":"Cattaneo","sequence":"additional","affiliation":[{"name":"Department of Medical Affairs, Cingulate Therapeutics, Kansas City, Kansas, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raul","family":"Silva","sequence":"additional","affiliation":[{"name":"Cingulate Therapeutics, Kansas City, Kansas, USA."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,7,22]]},"reference":[{"key":"e_1_3_5_2_1","doi-asserted-by":"publisher","DOI":"10.2165\/00023210-200822080-00006"},{"key":"e_1_3_5_3_1","unstructured":"Brams M Silva R Straughn A et al. 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