在ClinicalTrials.gov网站上,裸盖菇素治疗重度抑郁症临床试验的调控一致性:一项横断面分析。

IF 3.6 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Damian Swieczkowski, Aleksander Kwaśny, Michal Pruc, Zuzanna Gaca, Lukasz Szarpak, Wiesław J Cubała
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引用次数: 0

摘要

在包括裸盖菇素在内的致幻物质的临床开发中,遵守法规至关重要。本研究旨在检查裸盖菇素治疗重度抑郁症(MDD)和难治性抑郁症(TRD)的临床试验方案与既定监管要求的一致性。使用关键词“裸盖菇素”和“裸盖菇素”在ClinicalTrials.gov上进行了横断面调查,以识别具有发布试验方案的介入性研究。仅包括MDD和TRD协议。数据提取侧重于关键的监管方面,包括安全性、功能性解盲、预期偏差和研究性医疗产品的分布。确定了11个裸盖菇素试验方案,其中4个符合纳入标准。最常见的裸盖菇素剂量为25毫克。两项试验为双盲试验。虽然分析的方案表面上遵守了监管要求,但在解决潜在的药物相互作用、急性和慢性同时使用抗抑郁药和禁用药物方面存在差距。某些方面,如功能解盲或期望偏差,并没有共享所有的途径。风险缓解战略主要基于外部标准。双相情感障碍或分裂情感障碍患者被排除在外。这项研究强调了在严格遵守监管标准的情况下进行迷幻药临床试验的重要性。未来的研究应侧重于提高监管依从性和探索致幻剂在更广泛的患者群体中的功效。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Regulatory Alignment of Psilocybin Clinical Trials in Major Depressive Disorder on ClinicalTrials.gov: A Cross-Sectional Analysis.

Regulatory compliance is crucial in the clinical development of psychedelic substances, including psilocybin. This study aimed to examine the alignment of clinical trial protocols for psilocybin in the treatment of major depressive disorder (MDD) and treatment-resistant depression (TRD) with established regulatory requirements.A cross-sectional investigation was conducted on ClinicalTrials.gov using the keywords: "Psilocybin" and "Psilocin" to identify interventional studies with posted trial protocols. Only protocols for MDD and TRD were included. Data extraction focused on key regulatory aspects, including safety, functional unblinding, expectancy bias, and the distribution of investigational medical products.Eleven psilocybin trial protocols were identified, with four meeting the inclusion criteria. The most commonly studied psilocybin dose was 25 mg. Two trials were double-blind. Although the analyzed protocols superficially adhered to regulatory requirements, there were gaps in addressing potential drug interactions, the acute and chronic concurrent use of antidepressants, and prohibited medications. Certain aspects, such as functional unblinding or expectancy bias, did not share all pathways. Risk mitigation strategies were primarily based on external criteria. Patients with bipolar spectrum disorders or schizoaffective disorders were excluded.This study underscores the importance of conducting clinical trials on psychedelics in strict adherence to regulatory standards. Future research should focus on improving regulatory compliance and exploring the efficacy of psychedelics in broader patient populations.

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来源期刊
Pharmacopsychiatry
Pharmacopsychiatry 医学-精神病学
CiteScore
7.10
自引率
9.30%
发文量
54
审稿时长
6-12 weeks
期刊介绍: Covering advances in the fi eld of psychotropic drugs, Pharmaco psychiatry provides psychiatrists, neuroscientists and clinicians with key clinical insights and describes new avenues of research and treatment. The pharmacological and neurobiological bases of psychiatric disorders are discussed by presenting clinical and experimental research.
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