Paris XI University, INSERM U 669, Department of Psychiatry, Bicêtre University Hospital, Assistance Publique-Hôpitaux de Paris, France.
Int J Neuropsychopharmacol. 2013 Nov;16(10):2219-34. doi: 10.1017/S1461145713000679. Epub 2013 Jul 3.
In the present randomized, controlled, double-blind trial (12 wk treatment plus double-blind extension for 12 wk), 25-50 mg/d agomelatine (n = 164) and 10-20 mg/d escitalopram (n = 160) were compared for short- and long-term efficacy, subjective sleep and tolerability. The effects of these drugs on emotional experiences were also compared in patients having completed the Oxford Questionnaire on the Emotional Side-Effects of Antidepressants (agomelatine: n = 25; escitalopram: n = 20). Agomelatine and escitalopram similarly improved depressive symptoms, with clinically relevant score changes over 12 and 24 wk and notable percentage of remitters (week 12: 60.9 and 54.4%; week 24: 69.6 and 63.1% respectively). Over the 12 and 24-wk treatment periods, the 'global satisfaction on sleep' scores increased in both treatment groups and did not differ between groups. Satisfaction with sleep-wake quality was high in both groups; the 'wellness feeling on waking' was more improved with agomelatine than with escitalopram (p = 0.02). In patients with pronounced sleep complaints, quality of sleep and feeling on waking were significantly more improved with agomelatine than with escitalopram (p = 0.016 and p = 0.009, respectively). Emotional blunting was less frequent on agomelatine than on escitalopram. Indeed, 28% of patients on agomelatine vs. 60% on escitalopram felt that their emotions lacked intensity and 16% of patients on agomelatine vs. 53% on escitalopram felt that things that they cared about before illness did not seem important any more (p = 0.024). The tolerability profile of agomelatine was found to be superior to that of escitalopram and the incidence of patients with at least one emergent adverse event leading to treatment discontinuation was lower in the agomelatine group than in the escitalopram group (5.5 vs. 10.6%). The findings suggest that agomelatine displays additional long-term clinical benefits on sleep-wake quality and emotional experiences over escitalopram in the management of depression.
在这项随机、对照、双盲试验（12 周治疗期加 12 周双盲扩展期）中，对比了 25-50 毫克/天阿戈美拉汀（n = 164）和 10-20 毫克/天依西酞普兰（n = 160）的短期和长期疗效、主观睡眠和耐受性。还比较了在完成抗抑郁药物情绪副作用牛津问卷的患者（阿戈美拉汀：n = 25；依西酞普兰：n = 20）中这些药物对情绪体验的影响。阿戈美拉汀和依西酞普兰同样改善了抑郁症状，在 12 周和 24 周时具有临床相关的评分变化，且有显著比例的缓解者（第 12 周：60.9%和 54.4%；第 24 周：69.6%和 63.1%）。在 12 周和 24 周的治疗期间，两组的“总体睡眠满意度”评分均增加，且两组间无差异。两组患者的睡眠-觉醒质量满意度均较高；与依西酞普兰相比，阿戈美拉汀更能改善“醒来时的健康感”（p = 0.02）。在有明显睡眠主诉的患者中，与依西酞普兰相比，阿戈美拉汀更能显著改善睡眠质量和醒来时的感觉（p = 0.016 和 p = 0.009）。与依西酞普兰相比，阿戈美拉汀较少出现情绪迟钝。实际上，28%的阿戈美拉汀组患者感觉情绪缺乏强度，60%的依西酞普兰组患者感觉他们以前关心的事情不再重要（p = 0.024）。与依西酞普兰相比，阿戈美拉汀的耐受性更好，且因至少 1 次不良事件而导致治疗中断的患者比例在阿戈美拉汀组低于依西酞普兰组（5.5% vs. 10.6%）。研究结果表明，与依西酞普兰相比，阿戈美拉汀在治疗抑郁症时，在改善睡眠-觉醒质量和情绪体验方面具有额外的长期临床获益。
