Spriggs Meg J, Douglass Hannah M, Park Rebecca J, Read Tim, Danby Jennifer L, de Magalhães Frederico J C, Alderton Kirsty L, Williams Tim M, Blemings Allan, Lafrance Adele, Nicholls Dasha E, Erritzoe David, Nutt David J, Carhart-Harris Robin L
Centre for Psychedelic Research, Department of Brain Sciences, Imperial College London, London, United Kingdom.
OxBREaD Research Group, Department of Psychiatry, University of Oxford, Oxford, United Kingdom.
Front Psychiatry. 2021 Oct 20;12:735523. doi: 10.3389/fpsyt.2021.735523. eCollection 2021.
Anorexia nervosa (AN) is a serious and life-threatening psychiatric condition. With a paucity of approved treatments, there is a desperate need for novel treatment avenues to be explored. Here, we present (1) an overview of the ways through which Public Patient Involvement (PPI) has informed a trial of psilocybin-assisted therapy for AN and (2) a protocol for a pilot study of psilocybin-assisted therapy in AN currently underway at Imperial College London. The study aims to assess the feasibility, brain mechanisms and preliminary outcomes of treating anorexia nervosa with psilocybin. (1) PPI: Across two online focus groups, eleven individuals with lived experience of AN were presented with an overview of the protocol. Their feedback not only identified solutions to possible barriers for future participants, but also helped the research team to better understand the concept of " from the perspective of those with lived experience. (2) Protocol: Twenty female participants [21-65 years old, body mass index (BMI) 15 kg/m or above] will receive three oral doses of psilocybin (up to 25 mg) over a 6-week period delivered in a therapeutic environment and enveloped by psychological preparation and integration. We will work with participant support networks (care teams and an identified support person) throughout and there will be an extended remote follow-up period of 12 months. Our two-fold primary outcomes are (1) psychopathology (Eating Disorder Examination) across the 6-month follow-up and (2) readiness and motivation to engage in recovery (Readiness and Motivation Questionnaire) across the 6-week trial period. Neurophysiological outcome measures will be: (1) functional magnetic resonance imaging (fMRI) brain changes from baseline to 6-week endpoint and (2) post-acute changes in electroencephalography (EEG) activity, including an electrophysiological marker of neuronal plasticity. The results of this pilot study will not only shed light on the acceptability, brain mechanisms, and impression of the potential efficacy of psilocybin as an adjunct treatment for AN but will be essential in shaping a subsequent Randomised Control Trial (RCT) that would test this treatment against a suitable control condition. identifier: NCT04505189.
神经性厌食症（AN）是一种严重且危及生命的精神疾病。由于获批的治疗方法匮乏，迫切需要探索新的治疗途径。在此，我们呈现：（1）公众患者参与（PPI）为一项裸盖菇素辅助治疗AN的试验提供信息的方式概述；（2）伦敦帝国理工学院目前正在进行的一项裸盖菇素辅助治疗AN的试点研究方案。该研究旨在评估用裸盖菇素治疗神经性厌食症的可行性、脑机制和初步结果。（1）公众患者参与：在两个在线焦点小组中，向11名有AN亲身经历的个体介绍了该方案的概述。他们的反馈不仅确定了未来参与者可能遇到的障碍的解决方案，还帮助研究团队从“有亲身经历者的角度”更好地理解这一概念。（2）方案：20名女性参与者[21 - 65岁，体重指数（BMI）15kg/m²或以上]将在6周内分三次口服裸盖菇素（最高25mg），给药在治疗环境中进行，并辅以心理准备和整合。我们将在整个过程中与参与者支持网络（护理团队和指定的支持人员）合作，并有长达12个月的远程随访期。我们的双重主要结果是：（1）6个月随访期间的精神病理学（饮食失调检查）；（2）6周试验期内参与康复的准备程度和动机（准备程度和动机问卷）。神经生理学结果测量将包括：（1）从基线到6周终点的功能磁共振成像（fMRI）脑变化；（2）脑电图（EEG）活动的急性后变化，包括神经元可塑性的电生理标志物。这项试点研究的结果不仅将阐明裸盖菇素作为AN辅助治疗的可接受性、脑机制和潜在疗效印象，而且对于形成后续的随机对照试验（RCT）至关重要，该试验将在合适的对照条件下测试这种治疗方法。标识符：NCT04505189。
