Department of Nutrition and Drug Research, Faculty of Health Sciences, Institute of Public Health, Jagiellonian University Medical College, Kraków, Poland.
Department of Internal and Community Nursing, Institute of Nursing and Midwifery, Faculty of Health Sciences, Jagiellonian University Medical College, Kraków, Poland.
Expert Opin Emerg Drugs. 2023 Dec;28(4):241-256. doi: 10.1080/14728214.2023.2264180. Epub 2023 Dec 26.
Depression is a common disabling psychiatric disorder, which - in extreme cases - may lead to suicide if untreated or inadequately treated. Despite the availability of various treatments for depression, including pharmacotherapy, there is still a need to search for new agents with higher effectiveness and faster onset of action, especially for patients with treatment-resistant depression.
A substance that has attracted considerable attention for nearly a decade is psilocybin, a natural psychedelic found in psilocybin mushrooms. In this study, we evaluated the efficacy and safety of psilocybin in the treatment of depression, based on pivotal randomized clinical trials. Moreover, we used findings from observational studies regarding recreational use. We also looked at ongoing clinical trials and discussed the registration status and clinical potential of the drug.
Clinical phase I-II trials published to date reported promising results for psilocybin in the treatment of patients with major depressive disorder and treatment-resistant depression, in a relatively short time after administration. However, before psilocybin is approved for use and administered to patients with depression, the results of large ongoing phase III clinical trials are needed to confirm its efficacy and safety and to change the way it is perceived by physicians and patients.
抑郁症是一种常见的致残性精神障碍,如果未经治疗或治疗不当,在极端情况下可能导致自杀。尽管有多种治疗抑郁症的方法,包括药物治疗,但仍需要寻找新的、更有效、起效更快的药物,尤其是对治疗抵抗的抑郁症患者。
近十年来,一种名为裸盖菇素的天然致幻剂引起了广泛关注,它存在于裸盖菇蘑菇中。在这项研究中,我们基于关键的随机临床试验评估了裸盖菇素治疗抑郁症的疗效和安全性。此外,我们还利用了关于娱乐性使用的观察性研究结果。我们还查看了正在进行的临床试验,并讨论了该药物的注册状况和临床潜力。
迄今为止已发表的临床 I-II 期试验报告称,裸盖菇素在治疗重度抑郁症和治疗抵抗性抑郁症患者方面具有良好的疗效,在给药后相对较短的时间内即可起效。然而,在裸盖菇素被批准用于治疗抑郁症患者并应用于临床之前,还需要进行大规模的 III 期临床试验来验证其疗效和安全性,并改变医生和患者对它的看法。