Eszopiclone co-administered with fluoxetine in patients with insomnia coexisting with major depressive disorder
Eszopiclone co-administered with fluoxetine in patients with insomnia coexisting with major depressive disorder
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DOI：
10.1016/j.biopsych.2006.01.016
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发表时间：
2006-06-01
影响因子：
10.6
通讯作者：
Roth, T
中科院分区：
文献类型：
--
作者：
Fava, M;McCall, WV;Roth, T
背景资料。失眠和严重抑郁障碍(MDD)可以共存。方法：符合DSM-IV诊断MDD和失眠标准的患者(n=545)早晨服用氟西汀，每晚随机服用3 mg(ESZ+Flx)或安慰剂(PBO+Flx)，疗程8周。每周评估主观睡眠和日间功能。采用汉密尔顿抑郁量表(HAM-D-17)、临床总体印象改善量表(CGI-I)和严重程度量表(CGI-S)对患者进行评定。结果：联合用药组患者入睡潜伏期、入睡后觉醒时间(WASO)、总睡眠时间(TST)、睡眠质量、睡眠深度在所有双盲时间点均显著降低(P均<0.05)。联合治疗还导致：第4周HAM-D-17评分变化显著(p=.01)，第8周逐步改善(p=.002)；1周后所有时间点的CGI-I和CGI-S评分均显著改善(p<；0.05)；显著增加应答者(59%对48%；p=.009)和汇款者(42%对33%；治疗8周时耐受性良好，不良事件和辍学率相似。结论：在本研究中，埃索匹龙/氟西汀联合治疗耐受性相对较好，与快速、实质性和持续的睡眠改善有关，基于CGI的抗抑郁反应更快，抗抑郁效果更大。
Background. Insomnia and major depressive disorder (MDD) can coexist. This study evaluated the effect of adding eszopiclone to fluoxetine.Methods: Patients who met DSM-IV criteria for both MDD and insomnia (n = 545) received morning fluoxetine and were randomized to nightly eszopiclone 3 mg (ESZ+FLX) or placebo (PBO+FLX)for 8 weeks. Subjective sleep and daytime function were assessed weekly. Depression was assessed with the 17-item Hamilton Rating Scale for Depression (HAM-D-17) and the Clinical Global Impression Improvement (CGI-I) and Severity items (CGI-S).Results: Patients in the ESZ+FLX group bad significantly decreased sleep latency, wake time after sleep onset (WASO), increased total sleep time (TST), sleep quality, and depth of sleep at all double-blind time points (all p < .05). Eszopiclone co-therapy also resulted in: significantly greater changes in HAM-D-17 scores at Week 4 (p = .01) with progressive improvement at Week 8 (p = .002); significantly improved CGI-I and CGI-S scores at all time points beyond Week 1 (p < .05); and significantly more responders (59% vs. 48%'; p = .009) and remitters (42% vs. 33%; p = .03) at Week 8. Treatment was well tolerated, with similar adverse event and dropout rates.Conclusions: In this study, eszopiclone/fluoxetine co-therapy was relatively well tolerated and associated with rapid, substantial, and sustained sleep improvement, a faster onset of antidepressant response on the basis of CGI, and a greater magnitude of the antidepressant effect.