A pilot evaluation of the safety, tolerability, pharmacokinetics, and effectiveness of memantine in pediatric patients with attention-deficit/hyperactivity disorder combined type
A pilot evaluation of the safety, tolerability, pharmacokinetics, and effectiveness of memantine in pediatric patients with attention-deficit/hyperactivity disorder combined type
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DOI：
10.1089/cap.2006.0044
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发表时间：
2007-02-01
影响因子：
1.9
通讯作者：
Graham, Stephen M.
中科院分区：
文献类型：
--
作者：
Findling, Robert L.;McNamara, Nora K.;Graham, Stephen M.
背景资料：N-甲基-D-天冬氨酸（NMDA）受体活性紊乱可能在注意力缺陷多动障碍（ADHD）中发挥作用。目的：本研究是对NMDA受体拮抗剂美金刚治疗儿童ADHD的安全性、药代动力学和有效性的初步评价。美金刚口服溶液（2 mg/mL）滴定至10 mg/天（n = 8）或20 mg/天（n = 8）。收集用于药代动力学分析的安全性数据和血样。ADHD评定量表-IV（ADHD-IV）和临床总体印象的严重程度（CGI-S）量表测量的有效性memantine.Results：有没有停止由于不良事件（AE），严重AE，死亡，或自杀。大多数AE为轻度，发生在治疗第一周。与10 mg/天美金刚相比，20 mg/天美金刚剂量与更高的完成率和更大的ADHD-IV和CGI-S平均改善相关。药代动力学分析表明，美金刚的反应可能是剂量依赖性超过初始阈值concentration.Conclusions：这项试点研究表明，美金刚剂量为20毫克/天可能是一个安全的，可能是有效的治疗小儿多动症。美金刚在ADHD中的进一步研究似乎是必要的。
Background: Disturbances in N-methyl-D-aspartate (NMDA) receptor activity may play a role in attention-deficit/hyperactivity disorder (ADHD).Objective: This study is a preliminary evaluation of the safety, pharmacokinetics, and effectiveness of the NMDA receptor antagonist memantine in pediatric ADHD.Methods: An open-label, dose-finding, 8-week, trial in outpatients 6-12 years old with ADHD combined type. Memantine oral solution (2 mg/mL) was titrated to 10 mg/day (n = 8) or 20 mg/day (n = 8). Safety data and blood samples for pharmacokinetic analyses were collected. The ADHD Rating Scale-IV (ADHD-IV) and Clinical Global Impression of Severity (CGI-S) scale measured the effectiveness of memantine.Results: There were no discontinuations due to adverse events (AEs), serious AEs, deaths, or suicides. Most AEs were mild and occurred during the first week of treatment. The 20 mg/day memantine dose was associated with a higher rate of completion and larger mean improvement on the ADHD-IV and CGI-S than 10 mg/day memantine. Pharmacokinetic analyses suggest response to memantine may be dose-dependent beyond an initial threshold concentration.Conclusions: This pilot study suggests that a memantine dose of 20 mg/day may be a safe and possibly effective treatment for pediatric ADHD. Further investigations of memantine in ADHD appear to be warranted.