{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T06:35:12Z","timestamp":1780468512741,"version":"3.54.1"},"reference-count":43,"publisher":"Cambridge University Press (CUP)","issue":"5","license":[{"start":{"date-parts":[[2020,5,19]],"date-time":"2020-05-19T00:00:00Z","timestamp":1589846400000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["CNS Spectr."],"published-print":{"date-parts":[[2021,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec id=\"S1092852920001406_sec1\"><jats:title>Objective<\/jats:title><jats:p>The aim of this fixed-dose study was to evaluate the efficacy and safety of dasotraline in the treatment of patients with binge-eating disorder (BED).<\/jats:p><\/jats:sec><jats:sec id=\"S1092852920001406_sec2\" sec-type=\"methods\"><jats:title>Methods<\/jats:title><jats:p>Patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for BED were randomized to 12\u00a0weeks of double-blind treatment with fixed doses of dasotraline (4 and 6\u00a0mg\/d), or placebo. The primary efficacy endpoint was change in number of binge-eating (BE) days per week at week 12. Secondary efficacy endpoints included week 12 change on the BE CGI-Severity Scale (BE-CGI-S) and the Yale-Brown Obsessive\u2013Compulsive Scale Modified for BE (YBOCS-BE).<\/jats:p><\/jats:sec><jats:sec id=\"S1092852920001406_sec3\" sec-type=\"results\"><jats:title>Results<\/jats:title><jats:p>At week 12, treatment with dasotraline was associated with significant improvement in number of BE days per week on the dose of 6\u00a0mg\/d (N\u00a0=\u00a0162) vs placebo (N\u00a0=\u00a0162; \u22123.47 vs \u22122.92;<jats:italic>P<\/jats:italic>\u00a0=\u00a0.0045), but not 4\u00a0mg\/d (N\u00a0=\u00a0161; \u22123.21). Improvement vs placebo was observed for dasotraline 6 and 4\u00a0mg\/d, respectively, on the BE-CGI-S (effect size [ES]: 0.37 and 0.27) and on the YBOCS-BE total score (ES: 0.43 and 0.29). The most common adverse events on dasotraline were insomnia, dry mouth, headache, decreased appetite, nausea, and anxiety. Changes in blood pressure and pulse were minimal.<\/jats:p><\/jats:sec><jats:sec id=\"S1092852920001406_sec4\" sec-type=\"conclusions\"><jats:title>Conclusion<\/jats:title><jats:p>Treatment with dasotraline 6\u00a0mg\/d (but not 4\u00a0mg\/d) was associated with significantly greater reduction in BE days per week. Both doses of dasotraline were generally safe and well-tolerated and resulted in global improvement on the BE-CGI-S, as well as improvement in BE related obsessional thoughts and compulsive behaviors on the YBOCS-BE. These results confirm the findings of a previous flexible dose study.<\/jats:p><\/jats:sec>","DOI":"10.1017\/s1092852920001406","type":"journal-article","created":{"date-parts":[[2020,5,19]],"date-time":"2020-05-19T08:55:00Z","timestamp":1589878500000},"page":"481-490","source":"Crossref","is-referenced-by-count":24,"title":["Efficacy and safety of dasotraline in adults with binge-eating disorder: a randomized, placebo-controlled, fixed-dose clinical trial"],"prefix":"10.1017","volume":"26","author":[{"given":"Carlos M.","family":"Grilo","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan L.","family":"McElroy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James 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