MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study.
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mdma辅助治疗严重PTSD：一项随机、双盲、安慰剂对照的3期研究
DOI：
10.1038/s41591-021-01336-3
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发表时间：
2021-06
期刊：
影响因子：
82.9
通讯作者：
Doblin R
中科院分区：
文献类型：
--
作者：
Mitchell JM;Bogenschutz M;Lilienstein A;Harrison C;Kleiman S;Parker-Guilbert K;Ot'alora G M;Garas W;Paleos C;Gorman I;Nicholas C;Mithoefer M;Carlin S;Poulter B;Mithoefer A;Quevedo S;Wells G;Klaire SS;van der Kolk B;Tzarfaty K;Amiaz R;Worthy R;Shannon S;Woolley JD;Marta C;Gelfand Y;Hapke E;Amar S;Wallach Y;Brown R;Hamilton S;Wang JB;Coker A;Matthews R;de Boer A;Yazar-Klosinski B;Emerson A;Doblin R
创伤后应激障碍（PTSD）是一个重大的公共卫生问题，目前可用的治疗方法效果有限。我们报告了一项随机、双盲、安慰剂对照、多中心 3 期临床试验 (NCT03537014) 的结果，该试验旨在测试 3,4-亚甲二氧基甲基苯丙胺 (MDMA) 辅助疗法治疗严重 PTSD 患者的有效性和安全性，包括患有解离、抑郁、酒精和药物滥用病史以及儿童创伤等常见合并症的患者。精神科药物清除后，参与者（n = 90）被随机以 1:1 的比例接受 MDMA 或安慰剂的手动治疗，并结合 3 次预备治疗和 9 次综合治疗。使用 DSM-5 临床医生管理的 PTSD 量表（CAPS-5，主要终点）测量 PTSD 症状，并使用 Sheehan 残疾量表（SDS，次要终点）测量功能障碍，并在基线和最后一次实验后 2 个月时进行评估。在整个研究过程中跟踪不良事件和自杀倾向。研究发现，与安慰剂相比，MDMA 会引起 CAPS-5 评分显着且稳健的减弱（P<<0.0001，d=0.91），并显着降低 SDS 总分（P=0.0116，d=0.43）。完成治疗的参与者的 CAPS-5 评分平均变化在 MDMA 组中为 -24.4 (s.d. 11.6)，在安慰剂组中为 -13.9 (s.d. 11.5)。 MDMA 不会诱发滥用可能性、自杀或 QT 延长等不良事件。这些数据表明，与非活性安慰剂的手动治疗相比，MDMA 辅助治疗对于患有严重 PTSD 的个体非常有效，并且即使对于患有合并症的患者，治疗也是安全且耐受性良好的。我们的结论是，MDMA 辅助疗法代表了一种潜在的突破性疗法，值得加快临床评估。一项 3 期、双盲、随机、安慰剂对照试验的结果表明，MDMA 辅助疗法对于治疗严重的创伤后应激障碍是安全有效的。
Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. After psychiatric medication washout, participants (n = 90) were randomized 1:1 to receive manualized therapy with MDMA or with placebo, combined with three preparatory and nine integrative therapy sessions. PTSD symptoms, measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5, the primary endpoint), and functional impairment, measured with the Sheehan Disability Scale (SDS, the secondary endpoint) were assessed at baseline and at 2 months after the last experimental session. Adverse events and suicidality were tracked throughout the study. MDMA was found to induce significant and robust attenuation in CAPS-5 score compared with placebo (P < 0.0001, d = 0.91) and to significantly decrease the SDS total score (P = 0.0116, d = 0.43). The mean change in CAPS-5 scores in participants completing treatment was −24.4 (s.d. 11.6) in the MDMA group and −13.9 (s.d. 11.5) in the placebo group. MDMA did not induce adverse events of abuse potential, suicidality or QT prolongation. These data indicate that, compared with manualized therapy with inactive placebo, MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities. We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation. Results from a phase 3, double-blind, randomized, placebo-controlled trial demonstrate that MDMA-assisted therapy is safe and effective in treating severe post-traumatic stress disorder.
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