A Post-Hoc Analysis of Emotional Lability With Delayed-Release/Extended-Release Methylphenidate in Children Aged 6 to 12 Years of Age Participating in Two Phase 3 Clinical Trials

IF 2.7 3区医学 Q2 PSYCHIATRY

Journal of Attention Disorders Pub Date : 2024-04-11 DOI:10.1177/10870547241243155

Valerie K. Arnold, Frank A. López, Ann C. Childress, Michelle D. Po, Cassandra L. Uchida, Lewis Cuthbertson, Floyd R. Sallee, Bev Incledon

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引用次数: 0

Abstract

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.

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参与两项 3 期临床试验的 6 至 12 岁儿童服用缓释/长效哌醋甲酯后情绪不稳的事后分析

目的：DR/ER-MPH（原名 HLD200）是一种晚间剂量的缓释和缓释哌醋甲酯，已被批准用于治疗年龄≥6 岁的多动症患者。对两项关键性 3 期试验进行了事后分析：方法：评估在开放标签滴定阶段（HLD200-107）以及终点（HLD200-108）时治疗组和安慰剂组之间康纳氏全面指数-家长（CGI-P）EL分量表评分以及年龄和性别调整后T评分的差异。结果：在 HLD200-107 中（N = 117），CGI-P EL 子量表的平均得分在 6 周后从 5.3 降至 1.3（p < .0001）；在 HLD200-108 中，治疗组（n = 81）与安慰剂组（n = 80; 3.11 vs. 4.08; p = .0053）相比有显著改善。在这两项试验中，DR/ER-MPH 治疗的 T 评分均有所改善。结论：DR/ER-MPH 治疗在统计学上显著提高了 EL 的水平，使其达到非 ADHD 同龄人的水平（以 T 分数为背景）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Attention Disorders PSYCHIATRY-

CiteScore

7.60

自引率

6.70%

发文量

审稿时长

6-12 weeks

期刊介绍： Journal of Attention Disorders (JAD) focuses on basic and applied science concerning attention and related functions in children, adolescents, and adults. JAD publishes articles on diagnosis, comorbidity, neuropsychological functioning, psychopharmacology, and psychosocial issues. The journal also addresses practice, policy, and theory, as well as review articles, commentaries, in-depth analyses, empirical research articles, and case presentations or program evaluations.