Improving Methylphenidate Titration in Children with Attention-Deficit/Hyperactivity Disorder (ADHD): A Randomized Controlled Trial Using Placebo-Controlled Titration Implemented in Clinical Practice.

IF 3.4 3区医学 Q1 PEDIATRICS

Pediatric Drugs Pub Date : 2024-05-01 Epub Date: 2024-01-27 DOI:10.1007/s40272-023-00604-8

Karen Vertessen, Marjolein Luman, Pierre Bet, Catharina E Bergwerff, Marco Bottelier, Reino Stoffelsen, James M Swanson, Annemiek Wisse, Jos Twisk, Jaap Oosterlaan

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引用次数: 0

Abstract

Background and objectives: Concerns exist regarding the rising use of methylphenidate. A double-blind, placebo-controlled methylphenidate titration (PCT) for children with attention-deficit/hyperactivity disorder (ADHD) has shown potential to improve titration (i.e., detection of placebo responders and larger ADHD symptom improvement) in experimental settings. This study aims to determine if these advantages can be transferred to clinical settings.

Method: Children (aged 5-13 years) with an ADHD diagnosis and an indication to start methylphenidate (MPH) treatment were recruited. Participants were randomized to PCT or care as usual (CAU) in a 1:1 ratio followed by a 7-week randomized controlled trial (T1) and 6-month, naturalistic, open-label follow-up (T2). Parents, teachers, and physicians rated ADHD symptoms, ADHD medication use, MPH dosing, and treatment satisfaction using questionnaires.

Results: A total of 100 children were enrolled and randomized to PCT (n = 49) or CAU (n = 51). In the PCT group, we found 8.2% placebo responders, 16.3% non-responders, and 65.3% responders to MPH. With PCT compared with CAU, a significantly larger number of children discontinued MPH (T1: 24.5 vs 5.9%, p = 0.009; T2: 41.7 vs 10.4%, p < 0.001) and refrained from using other pharmacological treatment (T1: 20.4 vs 3.9%, p = 0.013; T2: 20.83 vs 6.25%, p = 0.002). At both timepoints, there were no significant differences between the groups in the average dose of MPH, ADHD symptoms, or treatment satisfaction.

Conclusions: PCT can be used to improve detection of children who do not benefit from MPH, and may therefore potentially reduce overtreatment of ADHD with MPH.

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改善注意力缺陷/多动障碍（ADHD）儿童的哌醋甲酯滴定：在临床实践中使用安慰剂控制滴定法的随机对照试验》（Randomized Controlled Trial Using Placebo-Controlled Titration Implemented in Clinical Practice）。

背景和目的：人们对哌醋甲酯的使用量不断增加表示担忧。针对注意力缺陷/多动障碍（ADHD）儿童的双盲安慰剂对照哌醋甲酯滴定法（PCT）已显示出在实验环境中改进滴定法的潜力（即发现安慰剂应答者和较大的 ADHD 症状改善）。本研究旨在确定这些优势能否应用于临床：方法：招募确诊为多动症并有开始哌醋甲酯（MPH）治疗指征的儿童（5-13 岁）。参与者按1:1的比例随机接受PCT或常规治疗（CAU），然后进行为期7周的随机对照试验（T1）和为期6个月的自然、开放标签随访（T2）。家长、教师和医生通过问卷对ADHD症状、ADHD药物使用、MPH剂量和治疗满意度进行评分：共有 100 名儿童入选，并被随机分配到 PCT 组（49 人）或 CAU 组（51 人）。在 PCT 组中，我们发现安慰剂应答者占 8.2%，无应答者占 16.3%，而 MPH 应答者占 65.3%。与 CAU 相比，PCT 组中停用 MPH 的儿童人数明显增多（T1：24.5% 对 5.9%，P = 0.009；T2：41.7% 对 10.4%，P 结论：PCT 可用于提高对 MPH 的检测率，并可减少对 MPH 的依赖性：PCT 可用于更好地发现不能从多巴胺羟乙酸中获益的儿童，因此有可能减少多巴胺羟乙酸对多动症的过度治疗。

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

Pediatric Drugs PEDIATRICS-PHARMACOLOGY & PHARMACY

CiteScore

7.20

自引率

0.00%

发文量

审稿时长

>12 weeks

期刊介绍： Pediatric Drugs promotes the optimization and advancement of all aspects of pharmacotherapy for healthcare professionals interested in pediatric drug therapy (including vaccines). The program of review and original research articles provides healthcare decision makers with clinically applicable knowledge on issues relevant to drug therapy in all areas of neonatology and the care of children and adolescents. The Journal includes: -overviews of contentious or emerging issues. -comprehensive narrative reviews of topics relating to the effective and safe management of drug therapy through all stages of pediatric development. -practical reviews covering optimum drug management of specific clinical situations. -systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. -Adis Drug Reviews of the properties and place in therapy of both newer and established drugs in the pediatric population. -original research articles reporting the results of well-designed studies with a strong link to clinical practice, such as clinical pharmacodynamic and pharmacokinetic studies, clinical trials, meta-analyses, outcomes research, and pharmacoeconomic and pharmacoepidemiological studies. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pediatric Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.