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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Rucker , J J , Marwood , L , Ajantaival , R-L J , Bird , C , Eriksson , H , Harrison , J , Lennard-Jones , M , Mistry , S , Saldarini , F , Stansfield , S , Tai , S J , Williams , S , Weston , N , Malievskaia , E & Young , A H 2022 , ' 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 ' , Journal of Psychopharmacology , vol. 36 , no. 1 , pp. 114-125 . https://doi.org/10.1177/02698811211064720

Title: 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
Author: Rucker, James J.; Marwood, Lindsey; Ajantaival, Riikka-Liisa J.; Bird, Catherine; Eriksson, Hans; Harrison, John; Lennard-Jones, Molly; Mistry, Sunil; Saldarini, Francesco; Stansfield, Susan; Tai, Sara J.; Williams, Sam; Weston, Neil; Malievskaia, Ekaterina; Young, Allan H.
Contributor organization: Clinicum
Helsinki University Hospital Area
Date: 2022-01
Language: eng
Number of pages: 12
Belongs to series: Journal of Psychopharmacology
ISSN: 0269-8811
DOI: https://doi.org/10.1177/02698811211064720
URI: http://hdl.handle.net/10138/340554
Abstract: Background: 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. Aim: 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. Methods: 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. Results: 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. Conclusions: 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.
Subject: Psilocybin
cognition
emotional processing
placebo-controlled
randomised clinical trial
LIFE-THREATENING CANCER
SEROTONERGIC SYSTEM
AGONIST PSILOCYBIN
DOUBLE-BLIND
VALIDATION
ANXIETY
EMPATHY
MOOD
PERCEPTION
DEPRESSION
3112 Neurosciences
3124 Neurology and psychiatry
317 Pharmacy
Peer reviewed: Yes
Rights: cc_by
Usage restriction: openAccess
Self-archived version: publishedVersion


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