...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>The journal of clinical psychiatry >A double-blind, placebo-controlled study of armodafinil for excessive sleepiness in patients with treated obstructive sleep apnea and comorbid depression.
【24h】

A double-blind, placebo-controlled study of armodafinil for excessive sleepiness in patients with treated obstructive sleep apnea and comorbid depression.

机译：阿莫达非尼治疗阻塞性睡眠呼吸暂停和合并性抑郁症患者过度嗜睡的双盲，安慰剂对照研究。

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

OBJECTIVE: Treatment of excessive sleepiness in the context of obstructive sleep apnea (OSA) may be particularly difficult in those with depression because depression and/or antidepressant medications may cause sleepiness and fatigue in addition to that due to the OSA. This study evaluating armodafinil, a nonamphetamine wakefulness-promoting medication, is the first trial for treatment of excessive sleepiness in patients with treated OSA and comorbid depression. METHOD: Men and women with OSA diagnosed using International Classification of Sleep Disorders criteria being treated with continuous positive airway pressure and comorbid major depressive disorder or dysthymic disorder according to DSM-IV-TR criteria were enrolled into a 12-week, randomized, double-blind, parallel-group study between September 2007 and March 2009 at 60 outpatient sites. Patients maintained on stable monotherapy with a serotonergic antidepressant and with a 17-item Hamilton Depression Rating Scale score < 17 received placebo or armodafinil (target dose: 200 mg once daily). Coprimary outcomes were the proportion of patients with at least minimal improvement on the Clinical Global Impression of Change (CGI-C) as related to excessive sleepiness and mean change from baseline in Maintenance of Wakefulness Test mean sleep latency at final visit; the key secondary outcome was mean change in the Epworth Sleepiness Scale score. RESULTS: 249 patients were enrolled: 125 in the armodafinil group and 124 in the placebo group. The proportion of patients with at least minimal improvement on the CGI-C was statistically significantly greater in the armodafinil group (69%) compared with the placebo group (53%, P = .012). Mean (SD) increase in Maintenance of Wakefulness Test sleep latency was numerically but not significantly greater following armodafinil (2.6 [7.1] min) versus placebo (1.1 [7.6] min, P = .30) treatment. Mean decrease in Epworth Sleepiness Scale score was greater in the armodafinil group (-6.3 [4.8]) than in the placebo group (-4.8 [4.9], nominal P = .003). Headache, dry mouth, and insomnia were the most common adverse events occurring with armodafinil treatment. There was no clinically significant effect on depression in either group as measured by the Quick Inventory of Depressive Symptomatology-Self-Report 16. CONCLUSIONS: Armodafinil significantly improved overall clinical condition related to excessive sleepiness as rated by the CGI-C and was well tolerated in patients with treated OSA and comorbid depression. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00518986.
机译：目的：对于抑郁症患者，在阻塞性睡眠呼吸暂停（OSA）情况下过度困倦的治疗可能特别困难，因为除OSA之外，抑郁症和/或抗抑郁药可能还会导致困倦和疲劳。这项评估armodafinil（一种非苯丙胺觉醒促进药物）的研究是治疗OSA和合并抑郁症患者过度嗜睡的第一项试验。方法：将根据国际睡眠障碍分类标准诊断为患有OSA的男性和女性，根据DSM-IV-TR标准接受持续气道正压通气治疗和合并性重度抑郁症或运动障碍性疾病的治疗，为期12周，随机，双2007年9月至2009年3月在60个门诊地点进行的盲人平行研究。维持血清素能抗抑郁药且汉密尔顿抑郁等级量表评分小于17的稳定单药治疗的患者接受安慰剂或armodafinil（目标剂量：每天200 mg）。首要的结果是与过度嗜睡有关的临床总体变化印象（CGI-C）至少有最小改善的患者比例，以及维持睡眠状态测试中基线平均变化的平均值，即最终就诊时的睡眠潜伏期。关键的次要结局是爱泼华嗜睡量表评分的平均变化。结果：249名患者入组：阿莫达非尼组125例，安慰剂组124例。与安慰剂组相比，阿莫达非尼组（69％）的CGI-C改善至少达到最低程度的患者比例在统计学上显着更高（53％，P = .012）。维持清醒测试的平均（SD）数值增加，但阿莫达非（2.6 [7.1] min）与安慰剂（1.1 [7.6] min，P = .30）治疗后的睡眠潜伏期在数值上并没有显着增加。阿莫达非尼组（-6.3 [4.8]）的Epworth嗜睡量表评分平均下降幅度大于安慰剂组（-4.8 [4.9]，名义P = 0.003）。头痛，口干和失眠是使用armodafinil治疗时最常见的不良事件。抑郁症状快速调查表-自我报告16均未显示两组对抑郁症的临床显着影响。结论：Armodafinil显着改善了与过度嗜睡有关的总体临床状况，如CGI-C所评估，并且在患有OSA并存抑郁症的患者。试验注册：clinicaltrials.gov标识符：NCT00518986。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号