Objective:DR/ER-MPH (formerly HLD200) is an evening-dosed delayed-release and extended-release methylphenidate approved for the treatment of ADHD in patients ≥6 years. Post hoc analyses of two pivotal Phase 3 trials: HLD200-107 (NCT02493777) and HLD200-108 (NCT02520388) evaluated emotional lability (EL) with DR/ER-MPH treatment.Methods:Differences in Conners Global Index—Parent (CGI-P) EL subscale scores and age- and gender-adjusted T-scores over an open-label titration phase (HLD200-107) and between treatment and placebo groups at endpoint (HLD200-108) were evaluated.Results:In HLD200-107 ( N = 117) mean CGI-P EL subscale scores improved from 5.3 to 1.3 ( p < .0001) after 6 weeks; in HLD200-108 significant improvements were observed in the treatment group ( n = 81) versus placebo ( n = 80; 3.11 vs. 4.08; p = .0053). T-scores showed an improvement with DR/ER-MPH treatment in both trials. Few emotional adverse events (AEs) were reported.Conclusion:DR/ER-MPH treatment resulted in statistically significant improvements in EL to the level of non-ADHD peers as contextualized by T-scores.

中文翻译：

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对参加两项 3 期临床试验的 6 至 12 岁儿童延迟释放/延长释放哌甲酯的情绪不稳定性进行事后分析

目的：DR/ER-MPH（以前的 HLD200）是一种晚间给药的缓释和缓释哌醋甲酯，被批准用于治疗 6 岁以上的 ADHD 患者。两项关键 3 期试验的事后分析：HLD200-107 (NCT02493777) 和 HLD200-108 (NCT02520388) 评估了 DR/ER-MPH 治疗的情绪不稳定性 (EL)。 方法：Conners 全球指数 - 父母 (CGI-P) 的差异) 评估开放标签滴定阶段 (HLD200-107) 以及终点时治疗组和安慰剂组之间 (HLD200-108) 的 EL 子量表评分以及年龄和性别调整的 T 评分。 结果：在 HLD200-107 中（ N = 117) 6 周后，平均 CGI-P EL 子量表分数从 5.3 提高到 1.3 (p < .0001)；在 HLD200-108 中，与安慰剂组 (n = 80；3.11 vs. 4.08；p = .0053) 相比，治疗组 (n = 81) 观察到显着改善。两项试验中 DR/ER-MPH 治疗的 T 评分均有所改善。很少有情绪不良事件 (AE) 被报道。结论：DR/ER-MPH 治疗使 EL 显着改善，达到非 ADHD 同龄人的水平（根据 T 分数）。