Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial.
Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder: A Randomized Clinical Trial.
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DOI：
10.1001/jamapsychiatry.2020.3285
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发表时间：
2021-05-01
期刊：
影响因子：
25.8
通讯作者：
Griffiths RR
中科院分区：
文献类型：
--
作者：
Davis AK;Barrett FS;May DG;Cosimano MP;Sepeda ND;Johnson MW;Finan PH;Griffiths RR
这项随机临床试验检查了裸盖菇素作为心理治疗和其他治疗重度抑郁症的辅助治疗的疗效。裸盖菇素辅助治疗对重度抑郁症患者有效吗？在这项随机临床试验中，24名重度抑郁症患者接受了立即接受裸盖菇素辅助治疗的患者与延迟治疗的患者相比，在1个月的随访中，盲法临床医生评估的抑郁严重程度和自我报告的次要结局均有所改善。这项随机临床试验发现，裸盖菇素辅助治疗对重度抑郁症患者产生大，快速和持续的抗抑郁作用是有效的。重度抑郁症（MDD）是一个巨大的公共卫生负担，但目前的治疗方法的有效性和依从性有限。最近的证据表明，1或2个管理psilocybin与心理支持产生抗抑郁作用的癌症患者和难治性抑郁症。探讨裸盖菇素治疗抑郁症的疗效。这项随机、等待名单对照的临床试验是在马里兰州巴尔的摩约翰霍普金斯湾景医疗中心的迷幻药和意识研究中心进行的。年龄在21至75岁之间，诊断为MDD，目前未使用抗抑郁药物，并且没有精神病史，严重自杀企图或住院史的成年人有资格参加。入组时间为2017年8月至2019年4月，4周主要结局评估于2019年7月完成。共有27名参与者被随机分配到立即治疗条件组（n = 15）或延迟治疗条件组（等待列表控制条件; n = 12）。数据分析于2019年7月1日至2020年7月31日进行，包括完成干预的参与者（可评价人群）。在支持性心理治疗（约11小时）的背景下，给予两次裸盖菇素治疗（第1次：20 mg/70 kg;第2次：30 mg/70 kg）（以不透明明胶胶囊和约100 mL水给药）。参与者被随机分配到开始治疗立即或8周后延迟。在基线（入组要求评分≥17）和延迟治疗组入组后第5周和第8周（对应于立即治疗组干预后第1周和第4周），使用GRID-HAMD评分评估主要结局（抑郁严重程度）。次要结局包括抑郁症状自评快速量表（QIDS-SR）。在随机化的参与者中，27人中有24人（89%）完成了干预以及第1周和第4周的会后评估。该人群的平均（SD）年龄为39.8（12.2）岁，由16名女性（67%）组成，平均（SD）基线GRID-HAMD评分为22.8（3.9）。即刻治疗组第1周和第4周的平均（SD）GRID-HAMD评分（8.0 [7.1]和8.5 [5.7]）在统计学上显著低于延迟治疗组第5周和第8周可比时间点的评分（23.8 [5.4]和23.5 [6.0]）。第5周（Cohen d = 2.5; 95% CI，1.4-3.5; P < .001）和第8周（Cohen d = 2.6; 95% CI，1.5-3.7; P < .001）的效应量较大。QIDS-SR记录了从基线到第1次治疗后第1天平均（SD）抑郁评分的快速下降（16.7 [3.5] vs 6.3 [4.4]; Cohen d = 2.6; 95% CI，1.8-3.5; P < .001），在第4周随访时仍保持统计学显著降低（6.0 [5.7]; Cohen d = 2.3; 95% CI，1.5-3.0; P < .001）。在总体样本中，第1周和第4周分别有17名（71%）和17名（71%）参与者对干预措施有临床显著反应（GRID-HAMD评分降低≥50%），第1周和第4周分别有14名（58%）和13名（54%）参与者缓解（≤7 GRID-HAMD评分）。研究结果表明，psilocybin与治疗是有效的治疗抑郁症，从而扩展了以前的研究结果，这种干预癌症和抑郁症患者和非随机研究的患者治疗难治性抑郁症。ClinicalTrials.gov标识符：NCT 03181529
This randomized clinical trial examines the efficacy of psilocybin as an adjunct to psychotherapy and other treatments for major depressive disorder. Is psilocybin-assisted therapy efficacious among patients with major depressive disorder? In this randomized clinical trial of 24 participants with major depressive disorder, participants who received immediate psilocybin-assisted therapy compared with delayed treatment showed improvement in blinded clinician rater–assessed depression severity and in self-reported secondary outcomes through the 1-month follow-up. This randomized clinical trial found that psilocybin-assisted therapy was efficacious in producing large, rapid, and sustained antidepressant effects in patients with major depressive disorder. Major depressive disorder (MDD) is a substantial public health burden, but current treatments have limited effectiveness and adherence. Recent evidence suggests that 1 or 2 administrations of psilocybin with psychological support produces antidepressant effects in patients with cancer and in those with treatment-resistant depression. To investigate the effect of psilocybin therapy in patients with MDD. This randomized, waiting list–controlled clinical trial was conducted at the Center for Psychedelic and Consciousness Research at Johns Hopkins Bayview Medical Center in Baltimore, Maryland. Adults aged 21 to 75 years with an MDD diagnosis, not currently using antidepressant medications, and without histories of psychotic disorder, serious suicide attempt, or hospitalization were eligible to participate. Enrollment occurred between August 2017 and April 2019, and the 4-week primary outcome assessments were completed in July 2019. A total of 27 participants were randomized to an immediate treatment condition group (n = 15) or delayed treatment condition group (waiting list control condition; n = 12). Data analysis was conducted from July 1, 2019, to July 31, 2020, and included participants who completed the intervention (evaluable population). Two psilocybin sessions (session 1: 20 mg/70 kg; session 2: 30 mg/70 kg) were given (administered in opaque gelatin capsules with approximately 100 mL of water) in the context of supportive psychotherapy (approximately 11 hours). Participants were randomized to begin treatment immediately or after an 8-week delay. The primary outcome, depression severity was assessed with the GRID-Hamilton Depression Rating Scale (GRID-HAMD) scores at baseline (score of ≥17 required for enrollment) and weeks 5 and 8 after enrollment for the delayed treatment group, which corresponded to weeks 1 and 4 after the intervention for the immediate treatment group. Secondary outcomes included the Quick Inventory of Depressive Symptomatology-Self Rated (QIDS-SR). Of the randomized participants, 24 of 27 (89%) completed the intervention and the week 1 and week 4 postsession assessments. This population had a mean (SD) age of 39.8 (12.2) years, was composed of 16 women (67%), and had a mean (SD) baseline GRID-HAMD score of 22.8 (3.9). The mean (SD) GRID-HAMD scores at weeks 1 and 4 (8.0 [7.1] and 8.5 [5.7]) in the immediate treatment group were statistically significantly lower than the scores at the comparable time points of weeks 5 and 8 (23.8 [5.4] and 23.5 [6.0]) in the delayed treatment group. The effect sizes were large at week 5 (Cohen d = 2.5; 95% CI, 1.4-3.5; P < .001) and week 8 (Cohen d = 2.6; 95% CI, 1.5-3.7; P < .001). The QIDS-SR documented a rapid decrease in mean (SD) depression score from baseline to day 1 after session 1 (16.7 [3.5] vs 6.3 [4.4]; Cohen d = 2.6; 95% CI, 1.8-3.5; P < .001), which remained statistically significantly reduced through the week 4 follow-up (6.0 [5.7]; Cohen d = 2.3; 95% CI, 1.5-3.0; P < .001). In the overall sample, 17 participants (71%) at week 1 and 17 (71%) at week 4 had a clinically significant response to the intervention (≥50% reduction in GRID-HAMD score), and 14 participants (58%) at week 1 and 13 participants (54%) at week 4 were in remission (≤7 GRID-HAMD score). Findings suggest that psilocybin with therapy is efficacious in treating MDD, thus extending the results of previous studies of this intervention in patients with cancer and depression and of a nonrandomized study in patients with treatment-resistant depression. ClinicalTrials.gov Identifier: NCT03181529
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影响因子：
13.5
作者：
Abdallah CG;Sanacora G;Duman RS;Krystal JH
通讯作者：
Krystal JH
影响因子：
5.3
作者：
Fekadu, Abebaw;Wooderson, Sarah;Cleare, Anthony J.
通讯作者：
Cleare, Anthony J.
DOI：
10.1177/0269881116675513
发表时间：
2016-12
期刊：
Journal of psychopharmacology (Oxford, England)
影响因子：
--
作者：
Griffiths RR;Johnson MW;Carducci MA;Umbricht A;Richards WA;Richards BD;Cosimano MP;Klinedinst MA
通讯作者：
Klinedinst MA
影响因子：
3.4
作者：
Beck, AT;Steer, RA;Ranieri, WF
通讯作者：
Ranieri, WF
影响因子：
3.8
作者：
Gaynes, Bradley N.;Warden, Diane;Rush, A. John
通讯作者：
Rush, A. John