Objective: To evaluate efficacy and safety of SPN-810 (extended-release molindone) in a Phase-2b, randomized, double-blind, placebo-controlled, dose-ranging study of children (6-12 years) with ADHD and persistent impulsive aggression (IA). Method: After lead-in, children were randomized to (a) placebo (N = 31); (b) low-dose (N = 29, 12/18 mg/day); (c) medium-dose (N = 30, 24/36 mg/day); and (4) high-dose (N = 31, 36/54 mg/day) groups. Treatment included ~2.5-week titration, 3-week maintenance, and 1-week tapering/conversion, alongside existing monotherapy (stimulants/nonstimulants) and behavioral therapy. The primary endpoint was change in Retrospective-Modified Overt Aggression Scale (R-MOAS) score at end of study, with safety monitored. Results: A total of 95 (78.5%) children completed the study. Aggression (R-MOAS) improved with low and medium doses (low dose: p = .031; medium dose: p = .024; high dose: p = .740). The most common adverse events were headache (10.0%), sedation (8.9%), and increased appetite (7.8%). Conclusion: These results suggest SPN-810 may be effective in reducing residual IA behaviors in children with ADHD. Research is still needed to support the benefit-risk profile of SPN-810 in pediatric populations.

中文翻译：

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延长释放吗啉酮治疗多动症冲动攻击的双盲随机研究。

目的：评估 SPN-810（缓释吗啉酮）在一项针对患有 ADHD 和持续性冲动的儿童（6-12 岁）的 2b 期、随机、双盲、安慰剂对照、剂量范围研究中的有效性和安全性。侵略（IA）。方法：导入后，儿童随机接受（a）安慰剂（N = 31）；(b) 低剂量（N = 29, 12/18 mg/天）；(c) 中等剂量（N = 30, 24/36 mg/天）；(4) 高剂量 (N = 31, 36/54 mg/day) 组。治疗包括约 2.5 周滴定、3 周维持和 1 周逐渐减量/转换，以及现有的单一疗法（兴奋剂/非兴奋剂）和行为疗法。主要终点是研究结束时回顾性改良公开攻击量表 (R-MOAS) 评分的变化，并监测安全性。结果：共有 95 名 (78.5%) 儿童完成了研究。攻击性 (R-MOAS) 在低剂量和中等剂量下得到改善（低剂量：p = .031；中等剂量：p = .024；高剂量：p = .740）。最常见的不良事件是头痛 (10.0%)、镇静 (8.9%) 和食欲增加 (7.8%)。结论：这些结果表明 SPN-810 可能有效减少 ADHD 儿童的残余 IA 行为。仍需要进行研究以支持 SPN-810 在儿科人群中的获益风险状况。