Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials
Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials
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DOI：
10.1007/s00213-020-05548-2
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发表时间：
2020-06-04
影响因子：
3.4
通讯作者：
Doblin, Rick
中科院分区：
文献类型：
--
作者：
Jerome, Lisa;Feduccia, Allison A.;Doblin, Rick
原理
创伤后应激障碍（PTSD）是一种慢性疾病，对个体的健康和人际关系具有广泛的负面影响。需要具有长期疗效的治疗方法来促进PTSD患者的安全和福祉。
目的
研究在使用3,4 - 亚甲基二氧基甲基苯丙胺（MDMA）辅助心理治疗PTSD后，PTSD症状的长期变化以及额外的益处/危害。
方法
参与者在双盲或开放标签的心理治疗期间接受两到三次有效剂量的MDMA（75 - 125毫克），同时还有额外的非药物治疗疗程。在基线、最后一次使用MDMA治疗后1到2个月（治疗结束时）以及最后一次使用MDMA治疗后至少12个月（长期随访），使用《精神障碍诊断与统计手册》第四版（DSM - IV）临床医生用PTSD量表（CAPS - IV）评估PTSD症状。混合效应重复测量（MMRM）分析评估CAPS - IV总严重程度评分的变化。总结每个时间点符合PTSD诊断标准的参与者人数。参与者完成一份长期随访调查问卷。
结果
从基线到治疗结束，CAPS - IV总严重程度评分显著降低（最小二乘均值（标准误）= - 44.8（2.82），p <.0001），科恩d效应量为1.58（95%置信区间 = 1.24，1.91）。从治疗结束到长期随访，CAPS - IV评分继续降低（最小二乘均值（标准误）= - 5.2（2.29），p <.05），科恩d效应量为0.23（95%置信区间 = 0.04，0.43）。不再符合PTSD标准的参与者人数从治疗结束时（56.0%）增加到长期随访时（67.0%）。大多数参与者报告有获益，包括人际关系和健康状况改善，少数参与者报告参与研究有不良影响。
结论
在MDMA辅助心理治疗后1到2个月，PTSD症状减轻，并且在治疗后至少12个月症状持续改善。3期试验正在对更大样本的慢性PTSD参与者研究这种新型治疗方法。
Rationale Posttraumatic stress disorder (PTSD) is a chronic condition that has wide-ranging negative effects on an individual's health and interpersonal relationships. Treatments with long-term benefits are needed to promote the safety and well-being of those suffering from PTSD. Objectives To examine long-term change in PTSD symptoms and additional benefits/harms after 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for treatment of PTSD. Methods Participants received two to three active doses of MDMA (75-125 mg) during blinded or open-label psychotherapy sessions with additional non-drug therapy sessions. PTSD symptoms were assessed using the Clinician-Administered PTSD Scale for DSM IV (CAPS-IV) at baseline, 1 to 2 months after the last active MDMA session (treatment exit), and at least 12 months post final MDMA session (LTFU). A mixed-effect repeated-measures (MMRM) analysis assessed changes in CAPS-IV total severity scores. The number of participants who met PTSD diagnostic criteria was summarized at each time point. Participants completed a long-term follow-up questionnaire. Results There was a significant reduction in CAPS-IV total severity scores from baseline to treatment exit (LS mean (SE) = - 44.8 (2.82), p < .0001), with a Cohen's d effect size of 1.58 (95% CI = 1.24, 1.91). CAPS-IV scores continued to decrease from treatment exit to LTFU (LS mean (SE) = - 5.2 (2.29), p < .05), with a Cohen's d effect size of 0.23 (95% CI = 0.04, 0.43). The number of participants who no longer met PTSD criteria increased from treatment exit (56.0%) to LTFU (67.0%). The majority of participants reported benefits, including improved relationships and well-being, and a minority reported harms from study participation. Conclusions PTSD symptoms were reduced 1 to 2 months after MDMA-assisted psychotherapy, and symptom improvement continued at least 12 months post-treatment. Phase 3 trials are investigating this novel treatment approach in a larger sample of participants with chronic PTSD.