中度至重度PTSD的MDMA辅助治疗:一个随机的,安慰剂控制的第3期试验
Jennifer M Mitchell1,2,3, Marcela Ot'alora G4, Bessel van der Kolk5
1Neuroscape, Department of Neurology, University of California, San Francisco, San Francisco, CA, USA. jennifer.mitchell@ucsf.edu.
Nature medicine
|September 14, 2023
概括
这项研究表明,3,4-甲基二氧化甲胺辅助疗法 (MDMA-AT) 在多样化的患者群体中显著降低了创伤后应激障碍 (PTSD) 症状和功能障碍. 发现MDMA-AT一般耐受性很好,提供了一个有前途的新治疗途径.
科学领域:
- 精神病学和行为科学
- 药理学和治疗学 药理学和治疗学
- 临床心理学 临床心理学
背景情况:
- 创伤后应激障碍 (PTSD) 是一种使人虚弱的疾病,有效的治疗选择有限.
- 现有的创伤后应激障碍疗法通常效果不佳,并且耐受性不佳.
- 对于新的治疗干预措施来解决PTSD治疗中的重大未满足需求,有极大的需求.
研究的目的:
- 评估3,4-甲基二氧化甲胺辅助疗法 (MDMA-AT) 的疗效和安全性,与在中度至重度PTSD的成年人中使用相同治疗的安慰剂相比.
- 评估MDMA-AT对PTSD症状严重程度和功能障碍的影响.
主要方法:
- 进行了一项多部位,随机,双盲,安慰剂控制的第三期试验.
- 患有中度至重度PTSD的参与者接受了MDMA辅助疗法或安慰剂治疗.
- 使用临床医生管理的DSM-5 (CAPS-5) 的PTSD尺度和Sheehan残疾量表 (SDS) 来衡量结果.
主要成果:
- 与安慰剂相比,MDMA-AT显示CAPS-5总严重性得分在统计学上显著降低 (P<0.001).
- 接受MDMA-AT治疗的参与者在SDS (P = 0.03) 测量的功能障碍中也显示出显著的改善.
- 治疗一般耐受良好,没有报告死亡或严重不良事件.
结论:
- 用MDMA辅助治疗是一种有效的治疗方法,可以减少多样化的人口中PTSD症状和功能障碍.
- 这些发现支持MDMA-AT作为中度至重度PTSD患者的安全和有效的治疗选择.
- 这项研究提供了强有力的证据,证明MDMA-AT在精神病治疗中的潜力.
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