临床试验设计中的问题——FDA拒绝MDMA的教训

IF 22.5 1区医学 Q1 PSYCHIATRY

JAMA Psychiatry Pub Date : 2025-04-16 DOI:10.1001/jamapsychiatry.2025.0442

Samuel T. Wilkinson, Gerard Sanacora

引用次数: 0

摘要

本观点探讨了美国食品和药物管理局（FDA）拒绝将亚甲基二氧甲基苯丙胺（MDMA）作为创伤后应激障碍治疗的潜在理由，包括缺乏盲法和相关临床试验的完整性问题。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Issues in Clinical Trial Design—Lessons From the FDA’s Rejection of MDMA

This Viewpoint explores potential justifications underlying the US Food and Drug Administration (FDA)’s rejection of methylenedioxymethamphetamine (MDMA) as a treatment for posttraumatic stress disorder, including lack of blinding and issues around the integrity of relevant clinical trials.

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来源期刊

JAMA Psychiatry PSYCHIATRY-

CiteScore

30.60

自引率

1.90%

发文量

233

期刊介绍： JAMA Psychiatry is a global, peer-reviewed journal catering to clinicians, scholars, and research scientists in psychiatry, mental health, behavioral science, and related fields. The Archives of Neurology & Psychiatry originated in 1919, splitting into two journals in 1959: Archives of Neurology and Archives of General Psychiatry. In 2013, these evolved into JAMA Neurology and JAMA Psychiatry, respectively. JAMA Psychiatry is affiliated with the JAMA Network, a group of peer-reviewed medical and specialty publications.