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赛洛西宾和艾司西酞普兰治疗抑郁症的比较试验
Trial of Psilocybin or Escitalopram for Depression


Robin Carhart-Harris ... 其他 • 2021.04.15
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• 青少年抑郁症 • SAGE-217治疗重性抑郁障碍患者的试验 • 艾氯胺酮治疗难治性抑郁症——美国FDA批准首种新型抗抑郁药

摘要


背景

赛洛西宾(psilocybin)可能具有抗抑郁特性,但目前缺乏赛洛西宾与抑郁症现有疗法之间的直接比较。

 

方法

在一项对长期中度至重度重性抑郁障碍患者开展的2期、双盲、随机、对照试验中,我们在6周期间比较了赛洛西宾和艾司西酞普兰(选择性5-羟色胺再摄取抑制剂)。我们以1∶1的比例将患者随机分组,一组接受两剂25 mg赛洛西宾(间隔3周)+6周每日安慰剂治疗(赛洛西宾组),另一组接受或者间隔3周的两剂1 mg赛洛西宾(间隔3周)+6周每日口服艾司西酞普兰治疗(艾司西酞普兰组);所有患者均接受了心理支持。主要结局是第6周时QIDS-SR-16(16项抑郁症状快速评估量表-自我报告[16-item Quick Inventory of Depressive Symptomatology-Self-Report];评分范围为0~27分,评分较高表示抑郁症较严重)评分相对于基线的变化。本试验有16项次要结局,包括第6周时的QIDS-SR-16应答(定义为评分降低>50%)和QIDS-SR-16缓解(定义为评分≤5分)。

 

结果

共计59例患者被纳入试验;30例被分配至赛洛西宾组,29例被分配至艾司西酞普兰组。基线时,赛洛西宾组和艾司西酞普兰组的QIDS-SR-16平均评分分别为14.5分和16.4分。在赛洛西宾组和艾司西酞普兰组中,评分从基线至第6周的平均(±SE)变化分别为-8.0±1.0分和-6.0±1.0分,组间差异为2.0分(95% CI,-5.0~0.9)(P=0.17)。赛洛西宾组70%的患者和艾司西酞普兰组48%的患者出现了QIDS-SR-16应答,组间差异为22个百分点(95% CI,-34~8);两组分别有57%和28%的患者出现了QIDS-SR-16缓解,组间差异为28个百分点(95% CI,2~54)。赛洛西宾的其他次要结局一般优于艾司西酞普兰,但我们未对分析进行多重比较校正。两组的不良事件发生率相似。

 

结论

根据第6周时QIDS-SR-16抑郁评分的变化,本试验表明,在经过选择的患者人群中,赛洛西宾和艾司西酞普兰的抗抑郁疗效无显著差异。赛洛西宾的次要结局一般优于艾司西酞普兰,但我们未对这些分析进行多重比较校正。我们需要开展规模更大、时间更长的试验来比较赛洛西宾和现有抗抑郁药(由亚历山大·莫斯利慈善信托基金[Alexander Mosley Charitable Trust]和英国帝国理工学院致幻剂研究中心[Imperial College London’s Centre for Psychedelic Research]资助,在ClinicalTrials.gov注册号为NCT03429075)。





作者信息

Robin Carhart-Harris, Ph.D., Bruna Giribaldi, B.Sc., Rosalind Watts, D.Clin.Psy., Michelle Baker-Jones, B.A., Ashleigh Murphy-Beiner, M.Sc., Roberta Murphy, M.D., Jonny Martell, M.D., Allan Blemings, M.Sc., David Erritzoe, M.D., and David J. Nutt, M.D.
From the Centre for Psychedelic Research, Department of Brain Sciences, Faculty of Medicine, Imperial College London, London. Address reprint requests to Dr. Carhart-Harris at Imperial College London, Burlington Danes Bldg., 160 Du Cane Rd., London W12 0NN, United Kingdom, or at r.carhart-harris@imperial.ac.uk.

 

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