严重PTSD的MDMA辅助疗法:一个随机,双盲,安慰剂控制的第三阶段研究
Jennifer M Mitchell1, Michael Bogenschutz1, Alia Lilienstein1
1Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA. Department of Psychiatry, New York University Grossman School of Medicine, New York, NY, USA. Multidisciplinary Association for Psychedelic Studies (MAPS), San Jose, CA, USA. MAPS Public Benefit Corporation (MAPS PBC), San Jose, CA, USA. Kleiman Consulting and Psychological Services, Sayreville, NJ, USA. KPG Psychological Services LLC, Brunswick, ME, USA. Aguazul-Bluewater Inc., Boulder, CO, USA. MDMA Therapy Training Program, MAPS Public Benefit Corporation, San Jose, CA, USA. Nautilus Sanctuary, New York, NY, USA. Fluence, Woodstock, NY, USA. Department of Family Medicine and Community Health, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. Medical University of South Carolina, Charleston, SC, USA. San Francisco Insight and Integration Center, San Francisco, CA, USA. British Columbia Centre on Substance Use, Vancouver, British Columbia, Canada. Boston University School of Medicine, Boston, MA, USA. Chaim Sheba Medical Center, Tel HaShomer, Israel. Ray Worthy Psychiatry LLC, New Orleans, LA, USA. Wholeness Center, Fort Collins, CO, USA. New School Research LLC, North Hollywood, CA, USA. Zen Therapeutic Solutions, Mt Pleasant, SC, USA. University of Toronto, Toronto, Ontario, Canada. Dr Simon Amar Inc., Montreal, Quebec, Canada. Be'er Ya'akov Ness Ziona Mental Health Center, Be'er Ya'akov, Israel. Stanford School of Medicine, Stanford, CA, USA.
与安慰剂相比,3,4-甲基二氧化甲胺 (MDMA) 辅助疗法显著改善了严重的创伤后应激障碍 (PTSD) 症状和功能障碍. 这种新的PTSD治疗方法在第三阶段临床试验中被发现是安全的,并且耐受性良好.
科学领域:
- 精神病学是一个精神病学.
- 临床心理学 临床心理学
- 药理学 药理学是指药理学的学科.
背景情况:
- 创伤后应激障碍 (PTSD) 是一个重要的公共卫生问题,治疗效果有限.
- 现有的治疗严重的PTSD,包括那些伴随疾病的治疗方法,往往产生适度的结果.
研究的目的:
- 评估3,4-甲基二氧化甲胺 (MDMA) 辅助治疗严重PTSD的疗效和安全性.
- 评估MDMA对多样化的患者群体中PTSD症状和功能障碍的影响.
主要方法:
- 一个随机,双盲,安慰剂控制的,多站点的第三期临床试验 (NCT03537014) 涉及90名参与者.
- 参与者接受了手动治疗,使用MDMA或安慰剂,以及在药物清洗后的准备和整合治疗课程.
- 主要终点:DSM-5 (CAPS-5) 的临床医生管理的PTSD尺度;次要终点:希恩残疾量表 (SDS).
主要成果:
- 与安慰剂相比,MDMA辅助疗法显示CAPS-5得分有显著且强大的降低 (P < 0.0001,d = 0.91).
- 在MDMA组中观察到SDS总得分的显著下降 (P = 0.0116,d = 0.43).
- MDMA没有显示与滥用潜力,自杀倾向或QT延长相关的不良事件,这表明它具有良好的安全性.
结论:
- 用MDMA辅助治疗对于严重的PTSD非常有效,并且耐受性很好,包括患有常见并发症的患者.
- 这种治疗代表了PTSD的潜在突破,需要加快临床评估.
- 这项研究支持MDMA辅助疗法作为患有严重PTSD的个体有前途的新疗法选择.
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