The effects of psilocybin on cognitive and emotional functions in healthy participants: Results from a phase 1, randomised, placebo-controlled trial involving simultaneous psilocybin administration and preparation.
The effects of psilocybin on cognitive and emotional functions in healthy participants: Results from a phase 1, randomised, placebo-controlled trial involving simultaneous psilocybin administration and preparation.
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DOI：
10.1177/02698811211064720
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发表时间：
2022-01
期刊：
影响因子：
--
通讯作者：
Young AH
中科院分区：
文献类型：
--
作者：
Rucker JJ;Marwood L;Ajantaival RJ;Bird C;Eriksson H;Harrison J;Lennard-Jones M;Mistry S;Saldarini F;Stansfield S;Tai SJ;Williams S;Weston N;Malievskaia E;Young AH
裸盖菇素是一种精神活性的5-羟色胺受体部分激动剂，据报道可以显著减轻抑郁症的临床症状。裸盖菇素对认知功能的影响尚未得到广泛或系统的研究。这项研究的目的是在迄今为止最大的裸盖菇素随机对照试验中，探索同时给健康参与者服用裸盖菇素的安全性。主要和次要终点评估了认知功能的短期和长期变化，如剑桥神经心理测试自动化电池(CANAB)小组评估的那样，以及情绪处理量表。安全性通过终点进行评估，包括认知功能、CANAB全球综合评分和治疗紧急不良事件(TEAE)监测。在这项第一阶段的随机、双盲、安慰剂对照研究中，健康参与者(n = ；平均年龄36.1 岁；41名女性，48名男性)被随机接受单剂量口服10或25 mg裸盖菇素或安慰剂，同时给最多6名参与者提供一对一的心理支持-每个参与者在整个治疗过程中都有一名指定的专职治疗师。总共报告了511例TEAE，持续时间的中位数为1.0 天；67%的TEAE在给药当天开始并消失。没有严重的TEAE，也没有导致研究退出的情况。在CANAB总体综合得分、CANAB认知领域得分或情绪处理量表得分方面，组间没有临床相关差异。这些结果表明，当同时给予多达6名参与者时，10 mg和25 mg剂量的裸盖菇素通常耐受性良好，对认知功能或情绪处理没有任何短期或长期有害影响。EudraCT(https://www.clinicaltrialsregister.eu/)编号：2018年-000978-30.
Psilocybin, a psychoactive serotonin receptor partial agonist, has been reported to acutely reduce clinical symptoms of depressive disorders. Psilocybin’s effects on cognitive function have not been widely or systematically studied. The aim of this study was to explore the safety of simultaneous administration of psilocybin to healthy participants in the largest randomised controlled trial of psilocybin to date. Primary and secondary endpoints assessed the short- and longer-term change in cognitive functioning, as assessed by a Cambridge Neuropsychological Test Automated Battery (CANTAB) Panel, and emotional processing scales. Safety was assessed via endpoints which included cognitive function, assessed by CANTAB global composite score, and treatment-emergent adverse event (TEAE) monitoring. In this phase 1, randomised, double-blind, placebo-controlled study, healthy participants (n = 89; mean age 36.1 years; 41 females, 48 males) were randomised to receive a single oral dose of 10 or 25 mg psilocybin, or placebo, administered simultaneously to up to six participants, with one-to-one psychological support – each participant having an assigned, dedicated therapist available throughout the session. In total, 511 TEAEs were reported, with a median duration of 1.0 day; 67% of all TEAEs started and resolved on the day of administration. There were no serious TEAEs, and none led to study withdrawal. There were no clinically relevant between-group differences in CANTAB global composite score, CANTAB cognitive domain scores, or emotional processing scale scores. These results indicate that 10 mg and 25 mg doses of psilocybin were generally well tolerated when given to up to six participants simultaneously and did not have any detrimental short- or long-term effects on cognitive functioning or emotional processing. EudraCT (https://www.clinicaltrialsregister.eu/) number: 2018-000978-30.
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DOI：
10.1073/pnas.1009396107
发表时间：
2010-10-05
影响因子：
11.1
作者：
Crockett, Molly J.;Clark, Luke;Robbins, Trevor W.
通讯作者：
Robbins, Trevor W.
影响因子：
25.8
作者：
Davis AK;Barrett FS;May DG;Cosimano MP;Sepeda ND;Johnson MW;Finan PH;Griffiths RR
通讯作者：
Griffiths RR
DOI：
10.1177/0269881116675513
发表时间：
2016-12
期刊：
Journal of psychopharmacology (Oxford, England)
影响因子：
--
作者：
Griffiths RR;Johnson MW;Carducci MA;Umbricht A;Richards WA;Richards BD;Cosimano MP;Klinedinst MA
通讯作者：
Klinedinst MA
影响因子：
4.1
作者：
Griffiths, R. R.;Richards, W. A.;Jesse, R.
通讯作者：
Jesse, R.
影响因子：
3.4
作者：
Hasler, F;Grimberg, U;Vollenweider, FX
通讯作者：
Vollenweider, FX