A randomized, double-blind study of continuation treatment for attention-deficit hyperactivity disorder after 1 year
A randomized, double-blind study of continuation treatment for attention-deficit hyperactivity disorder after 1 year
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DOI：
10.1016/j.biopsych.2006.03.066
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发表时间：
2007-03-01
影响因子：
10.6
通讯作者：
Biederman, Joseph
中科院分区：
文献类型：
--
作者：
Buitelaar, Jan K.;Michelson, David;Biederman, Joseph
背景：在患有 DSM-IV 定义的注意力缺陷/多动障碍 (ADHD) 的儿童和青少年 (n = 163) 中评估托莫西汀在治疗 1 年后维持症状反应的功效。 方法：受试者之前对托莫西汀有急性反应，并已完成一年的双盲托莫西汀治疗。然后，他们以双盲方式随机分配，继续服用托莫西汀或安慰剂替代 6 个月。 结果：托莫西汀在预防复发（Wilcoxon 检验，p = .008）和维持症状反应（ADHD 评定量表 IV 评分，p < .001）方面优于安慰剂。在被分配停药的受试者中，症状复发的严重程度通常低于研究开始时观察到的严重程度。结论：用托莫西汀治疗一年后，与安慰剂替代相比，在接下来的 6 个月内继续治疗与更好的结果相关。然而，停药后症状复发的程度在个体之间存在相当大的差异，这表明一些接受托莫西汀治疗一年并取得良好效果的受试者可能会巩固药物治疗期间取得的成果，并可能受益于无药物试验来评估持续药物治疗的必要性。
Background: The efficacy of atomoxetine in maintaining symptom response following 1 year of treatment was assessed in children and adolescents (n = 163) with DSM-IV defined attention-deficit/hyperactivity disorder (ADHD).Methods: Subjects had previously responded to atomoxetine acutely and had completed I year of double-blind atomoxetine treatment. They were then randomly assigned in double-blind fashion to continued atomoxetine or placebo substitution for 6 months.Results: Atomoxetine was superior to placebo in preventing relapse (Wilcoxon test, p = .008) and in maintaining symptom response (ADHD Rating Scale IV score, p < .001). Among subjects assigned to discontinuation, the magnitude of symptom return was generally to a level of severity less than that observed at study entry.Conclusions: Following I year of treatment with atomoxetine, continued treatment over the ensuing 6 months was associated with superior outcomes compared with placebo substitution. However, there was considerable variability between individuals in the magnitude of symptom return after drug discontinuation, suggesting that some subjects treated with atomoxetine for a year with good results may consolidate gains made during drug treatment and could benefit from a medication-free trial to assess the need for ongoing drug treatment.