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首页> 外文期刊>The journal of clinical psychiatry >Improved insomnia symptoms and sleep-related next-day functioning in patients with comorbid major depressive disorder and insomnia following concomitant zolpidem extended-release 12.5 mg and escitalopram treatment: a randomized controlled trial.
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Improved insomnia symptoms and sleep-related next-day functioning in patients with comorbid major depressive disorder and insomnia following concomitant zolpidem extended-release 12.5 mg and escitalopram treatment: a randomized controlled trial.

机译：合并唑吡坦缓释剂12.5 mg和依西酞普兰治疗后合并重度抑郁症和失眠患者的失眠症状改善和与睡眠有关的第二天功能改善：一项随机对照试验。

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OBJECTIVE: This investigation was performed to assess the efficacy and safety of zolpidem extended-release in patients with insomnia associated with major depressive disorder (MDD). METHOD: Patients (N = 385) received open-label escitalopram 10 mg/d and were randomized to concomitant zolpidem extended-release 12.5 mgight or placebo for 8 weeks (phase 1) in a randomized, parallel-group, multicenter trial. Responders (>/= 50% in 17-item Hamilton Depression Rating Scale [HDRS(17)] score) continued 16 weeks of double-blind treatment (phase 2); escitalopram only was given during a 2-week run-out period. The study was conducted between February 2006 and June 2007. The primary efficacy measure was change from baseline in subjective total sleep time. Secondary efficacy measures included subjective sleep-onset latency, number of awakenings, wake time after sleep onset, sleep quality, sleep-related next-day functioning, HDRS(17), Sleep Impact Scale score, Patient and Clinical Global Impressions of Insomnia Treatment, the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire, and the Quality of Life Enjoyment and Satisfaction Questionnaire. Adverse events were recorded throughout the study; sleep measures were also evaluated during the run-out period. RESULTS: Throughout phase 1, zolpidem extended-release led to significantly greater improvements in total sleep time (P < .0001), wake time after sleep onset, sleep onset latency, number of awakenings, and sleep quality (P
机译：目的：本研究旨在评估唑吡坦缓释剂在重度抑郁症（MDD）相关失眠患者中的疗效和安全性。方法：患者（N = 385）接受开放标签的依他普仑10 mg / d，并在随机，平行组，多中心试验中随机分配至伴随唑吡坦缓释12.5 mg / night或安慰剂治疗8周（1期）。响应者（在17个项目的汉密尔顿抑郁量表[HDRS（17）]中评分为> / = 50％）继续进行了16周的双盲治疗（第二阶段）;依他普仑只在2周的疗程内服用。该研究在2006年2月至2007年6月之间进行。主要功效指标是主观总睡眠时间相对于基线的变化。次要疗效指标包括主观睡眠发作潜伏期，觉醒次数，睡眠发作后的唤醒时间，睡眠质量，与睡眠有关的第二天功能，HDRS（17），睡眠影响量表评分，失眠治疗的患者和临床总体印象，麻萨诸塞州综合医院认知和身体功能调查表以及生活质量和满意度调查表。在整个研究中记录不良事件。睡眠期间还评估了睡眠措施。结果：在第1阶段的整个过程中，唑吡坦缓释剂显着改善了总睡眠时间（P <.0001），睡眠开始后的醒来时间，睡眠开始潜伏期，觉醒次数和睡眠质量（P

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