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

机译：治疗阻塞性睡眠呼吸暂停患者患者的嗜睡过度嗜睡和血管抑郁症的双盲，安慰剂对照研究。

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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：在抑郁症的情况下，在阻塞性睡眠呼吸暂停（OSA）背景下的治疗可能特别困难，因为抑郁症和/或抗抑郁药物可能引起嗜睡和疲劳，除了OSA。本研究评估了Armodafinil，一种壬酰胺醒来的促进药物，是治疗OSA和可血管抑郁症患者患者过度睡眠的试验。方法：使用ISA的男女诊断使用国际睡眠障碍障碍标准进行持续正气道压力和令人讨厌的主要抑郁症或根据DSM-IV-TR标准的令人难以紊乱的标准，进入12周，随机，双重2007年9月至2009年3月在60个门诊网站的盲目，并行群体研究。患者用Serotonergic抗抑郁药维持稳定的单药治疗，并用17件汉密尔顿抑郁率评级分数<17件接受安慰剂或Armodboinil（靶剂量：200mg每日一次）。与临床全球变化（CGI-C）的临床全球印象至少有关患者的患者的比例与基线的过度睡眠和平均变化有关，在最终访问期间睡眠潜伏期的睡眠性睡眠延迟。关键的次要结果是欧洲呼吸睡眠比分的平均变化。结果：249名患者在Armodboinil组中注册：125名，安慰剂组中的124名。与安慰剂组（53％，P = 0.012）相比，Armodafinil基团（69％）中，CGI-C对CGI-C的至少最小改善的患者的比例统计学显着更大。平均值（SD）维持醒来试验试验睡眠潜伏期的增加在数值上，但随着Armodafin（2.6 [7.1] min）与安慰剂（1.1 [7.6] min，p = .30）治疗不显着大。 ARMODAFINIL组的EPWORTH SEECHINY SCOMES评分的平均值更大（-6.3 [4.8]）比安慰剂组（-4.8 [4.9]，标称p = .003）。头痛，口干和失眠是随着Armodafinil治疗的最常见的不良事件。通过抑郁症状症状 - 自我报告的快速库存测量，对任一组的抑郁症没有临床显着效果。结论：Armodafinil显着改善了CGI-C评定的过度睡眠相关的整体临床病症，并耐受良好患者治疗OSA和同脉抑郁症。试验登记：ClinicalTrials.gov标识符：NCT00518986。

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