Faculty of Health Sciences, University of Lethbridge, 4401 University Drive, Lethbridge, AB, Canada.
Oregon Health & Science University-Portland State University School of Public Health, Portland, OR, USA.
Eur Child Adolesc Psychiatry. 2024 May;33(5):1355-1367. doi: 10.1007/s00787-023-02236-2. Epub 2023 Jun 8.
The Micronutrients for Attention-Deficit/Hyperactivity Disorder in Youth (MADDY) study evaluated the efficacy and safety of a multinutrient formula for children with ADHD and emotional dysregulation. The post-RCT open-label extension (OLE) compared the effect of treatment duration (8 weeks vs 16 weeks) on ADHD symptoms, height velocity, and adverse events (AEs).
Children aged 6-12 years randomized to multinutrients vs. placebo for 8 weeks (RCT), received an 8-week OLE for a total of 16 weeks. Assessments included the Clinical Global Impression-Improvement (CGI-I), Child and Adolescent Symptom Inventory-5 (CASI-5), Pediatric Adverse Events Rating Scale (PAERS), and anthropometric measures (height and weight).
Of the 126 in the RCT, 103 (81%) continued in the OLE. For those initially assigned to placebo, CGI-I responders increased from 23% in the RCT to 64% in the OLE; those who took multinutrients for 16 weeks increased from 53% (RCT) to 66% responders (OLE). Both groups improved on the CASI-5 composite score and subscales from week 8 to week 16 (all p-values < 0.01). The group taking 16 weeks of multinutrients had marginally greater height growth (2.3 cm) than those with 8 weeks (1.8 cm) (p = 0.07). No difference in AEs between groups was found.
The response rate to multinutrients by blinded clinician ratings at 8 weeks was maintained to 16 weeks; the response rate in the group initially assigned to placebo improved significantly with 8 weeks of multinutrients and almost caught up with 16 weeks. Longer time on multinutrients did not result in greater AEs, confirming an acceptable safety profile.
儿童注意缺陷多动障碍微量营养素研究（MADDY 研究）评估了一种多营养配方治疗伴有情绪失调的 ADHD 儿童的疗效和安全性。在 RCT 后的开放标签扩展（OLE）阶段，比较了 8 周与 16 周治疗时长对 ADHD 症状、身高增长速度和不良事件（AE）的影响。
6-12 岁儿童被随机分配接受多营养配方或安慰剂治疗 8 周（RCT），然后进行为期 8 周的 OLE 治疗，总共 16 周。评估包括临床总体印象-改善量表（CGI-I）、儿童青少年症状问卷-5（CASI-5）、儿科不良事件评定量表（PAERS）和人体测量指标（身高和体重）。
在 126 名入组 RCT 的儿童中，有 103 名（81%）继续进入 OLE 阶段。对于最初接受安慰剂的儿童，CGI-I 应答者从 RCT 中的 23%增加到 OLE 中的 64%；接受 16 周多营养配方治疗的儿童从 RCT 中的 53%（应答者）增加到 OLE 中的 66%（应答者）。两组在 CASI-5 总分和各分量表上的评分均从第 8 周改善至第 16 周（所有 p 值均<0.01）。接受 16 周多营养配方治疗的儿童身高增长（2.3cm）比接受 8 周治疗的儿童（1.8cm）稍大（p=0.07）。两组间不良事件发生率无差异。
经盲法临床医生评估，8 周时多营养配方的应答率维持至 16 周；最初接受安慰剂的儿童在接受 8 周多营养配方治疗后，应答率显著提高，并几乎与接受 16 周多营养配方治疗的儿童应答率相当。更长时间使用多营养配方并不会导致更多的不良事件，证实了其可接受的安全性。
