Effect of extended-release dexmethylphenidate and mixed amphetamine salts on sleep: a double-blind, randomized, crossover study in youth with attention-deficit hyperactivity disorder.
Effect of extended-release dexmethylphenidate and mixed amphetamine salts on sleep: a double-blind, randomized, crossover study in youth with attention-deficit hyperactivity disorder.
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DOI：
10.1007/s40263-014-0181-3
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发表时间：
2014-09
期刊：
影响因子：
6
通讯作者：
Gruber, R.
中科院分区：
文献类型：
--
作者：
Santisteban, J. A.;Stein, M. A.;Bergmame, L.;Gruber, R.
我们试图确定缓释（ER）右哌甲酯（d-MPH）和ER混合安非他明盐（MAS）对睡眠的客观测量的剂量反应效应。这是一项为期8周、双盲、安慰剂对照、随机化、两阶段、交叉研究，研究对象为经学龄儿童情感障碍儿童量表（K-SADS-PL）确认的注意力缺陷多动障碍（ADHD）青少年。从临床实践、同事推荐和传单中招募了10-17岁的儿童。参与者被随机分配到最初接受d-MPH或MAS。在每个4周的给药期内，儿童按升序接受3个剂量水平（10、20和25/30 mg），在研究的1周内以随机方式用安慰剂替代活性药物。4周后，受试者改用替代药物治疗4周。主要的结果测量是通过活动记录仪测量的睡眠持续时间。儿童、父母和研究人员对药物、剂量和安慰剂状态不知情。65名受试者符合入选标准并入组研究。其中，37名参与者有足够的睡眠数据进行分析。睡眠时间表测量显示，剂量对睡眠开始时间有显著影响（F（1，36）= 6.284; p < 0.05），与安慰剂相比，儿童接受20或30 mg剂量时的睡眠开始时间明显较晚（p < 0.05）。在实际睡眠持续时间上发现了显著的剂量效应（F（1，36）= 8.112; p < 0.05），与接受安慰剂的受试者相比，接受30 mg的受试者的实际睡眠持续时间显著更短（p < 0.05）。两种兴奋剂药物之间的睡眠时间或睡眠时间表没有显着差异。试验已完成，并关闭随访。较高的兴奋剂剂量与睡眠时间减少和睡眠开始时间推迟有关，无论药物类别如何。ClinicalTrials.gov：NCT 00393042。
We sought to determine the dose-response effects of extended-release (ER) dexmethylphenidate (d-MPH) and ER mixed amphetamine salts (MAS) on objective measures of sleep. This was an 8-week, double-blind, placebo-controlled, randomized, two period, crossover study of youth with attention-deficit hyperactivity disorder (ADHD) as confirmed by the Kiddie Schedule for Affective Disorders for School-Age Children–Present and Lifetime version (K-SADS-PL). Children aged 10–17 years were recruited from clinical practice, colleague referrals, and flyers. Participants were randomized to initially receive either d-MPH or MAS. During each 4-week drug period, children received three dose levels (10, 20, and 25/30 mg) in ascending order, with placebo substituted for active medication in a randomized fashion during 1 week of the study. After 4 weeks, participants were switched to the alternative medication for another 4 weeks of treatment. The main outcome measure was sleep duration as measured by actigraphy. Children, parents, and researchers were blinded to drug, dose, and placebo status. Sixty-five participants met the inclusion criteria and were enrolled in the study. Of these, 37 participants with sufficient sleep data for analysis were included. Sleep schedule measures showed a significant effect for dose on sleep start time (F(1,36) = 6.284; p < 0.05), with a significantly later sleep start time when children were receiving 20- or 30-mg doses, compared with placebo (p < 0.05). A significant dose effect was found on actual sleep duration (F(1,36) = 8.112; p < 0.05), with significantly shorter actual sleep duration for subjects receiving 30 mg compared with those receiving placebo (p < 0.05). There were no significant differences on sleep duration or sleep schedule between the two stimulant medications. The trial is complete and closed to follow-up. Higher stimulant doses were associated with reduced sleep duration and later sleep start times, regardless of medication class. ClinicalTrials.gov: NCT00393042.
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影响因子：
6.7
作者：
Charach, Alice;Fernandez, Rebeca
通讯作者：
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影响因子：
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作者：
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通讯作者：
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DOI：
10.1089/104454603322163853
发表时间：
2003-06-01
影响因子：
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作者：
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通讯作者：
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影响因子：
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作者：
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通讯作者：
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DOI：
10.1111/j.1365-2753.2007.00921.x
发表时间：
2008-12-01
影响因子：
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作者：
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通讯作者：
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