ObjectiveThe 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).MethodsPatients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for BED were randomized to 12 weeks of double-blind treatment with fixed doses of dasotraline (4 and 6 mg/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–Compulsive Scale Modified for BE (YBOCS-BE).ResultsAt week 12, treatment with dasotraline was associated with significant improvement in number of BE days per week on the dose of 6 mg/d (N = 162) vs placebo (N = 162; −3.47 vs −2.92; P = .0045), but not 4 mg/d (N = 161; −3.21). Improvement vs placebo was observed for dasotraline 6 and 4 mg/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.ConclusionTreatment with dasotraline 6 mg/d (but not 4 mg/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.

中文翻译：

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达索曲林在成人暴食症患者中的疗效和安全性：一项随机、安慰剂对照、固定剂量临床试验

目的这项固定剂量研究的目的是评估达索曲林治疗暴食症（BED）患者的疗效和安全性。方法将符合《精神疾病诊断和统计手册》第五版 BED 标准的患者随机分配到 12用固定剂量的达索曲林（4 和 6 毫克/天）或安慰剂进行为期数周的双盲治疗。主要疗效终点是第 12 周每周暴食 (BE) 天数的变化。次要疗效终点包括第 12 周 BE CGI-严重程度量表 (BE-CGI-S) 和耶鲁-布朗强迫症的变化—— BE (YBOCS-BE) 强迫量表修改。 结果在第 12 周，使用达索曲林治疗与 6 mg/d (N = 162) 与安慰剂 (N = 162; -3.47 对 -2.92；磷= .0045），但不是 4 mg/d（N = 161；-3.21）。在 BE-CGI-S（效应大小 [ES]：0.37 和 0.27）和 YBOCS-BE 总分（ES：0.43 和 0.29）上，分别观察到达索曲林 6 和 4 mg/d 的改善与安慰剂相比。达索曲林最常见的不良事件是失眠、口干、头痛、食欲下降、恶心和焦虑。血压和脉搏的变化很小。结论使用达索曲林 6 mg/d（但不是 4 mg/d）治疗与每周 BE 天数显着减少有关。两种剂量的达索曲林通常都是安全且耐受良好的，并导致 BE-CGI-S 的整体改善，以及 YBOCS-BE 上与 BE 相关的强迫性想法和强迫行为的改善。这些结果证实了先前灵活剂量研究的结果。