Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
VA Connecticut Healthcare System, West Haven, CT, USA.
J Psychopharmacol. 2023 Jul;37(7):698-706. doi: 10.1177/02698811231154852. Epub 2023 Mar 20.
Several early phase studies have demonstrated that psilocybin-assisted therapy has rapid-acting and persisting antidepressant effects from just one or two doses. However, methodological limitations (e.g., placebo-control, blinding) limit interpretability of the existing literature.
In an exploratory placebo-controlled, within-subject, fixed-order study, individuals with moderate to severe major depressive disorder were administered placebo ( = 19) followed by psilocybin (0.3 mg/kg) ( = 15) 4 weeks later. Dosing sessions were embedded within an manualized course of psychotherapy. Enhanced blinding procedures were used. Depression, anxiety, and quality of life were measured over a 16-week study period.
Depression and anxiety significantly improved following both placebo and psilocybin with no significant difference in the degree of change between the two conditions. However, antidepressant effect sizes were larger after psilocybin (' = 1.02-2.27) than after placebo (' = 0.65-0.99) and there were high rates of response (66.7%) and remission (46.7%) following psilocybin administration. Antidepressant effects following psilocybin persisted, on average, for 2 months and there were persisting improvements in mood-related quality of life domains. The strength of mystical-type experience during psilocybin dosing was not correlated with subsequent antidepressant effects.
The results of this exploratory study highlight the complex interplay between expectancy, therapy effects, and drug/placebo effects in psychedelic-assisted psychotherapy studies. Nonetheless, the acute and persisting clinical improvements observed following psilocybin support further study of its potential in the treatment of major depression. Future studies should more explicitly mitigate and measure expectancy effects and assess the impact of repeated dosing and different forms of psychotherapeutic support.
几项早期阶段的研究表明，只需一剂或两剂致幻蘑菇辅助治疗即可迅速产生并持续产生抗抑郁作用。然而，方法学上的限制（例如，安慰剂对照、盲法）限制了现有文献的解释。
在一项探索性的安慰剂对照、自身对照、固定顺序的研究中，中度至重度重度抑郁症患者先服用安慰剂（= 19），4 周后再服用裸盖菇素（0.3 mg/kg）（= 15）。剂量阶段嵌入在一个经过验证的心理治疗课程中。使用了增强的盲法程序。在 16 周的研究期间测量了抑郁、焦虑和生活质量。
安慰剂和裸盖菇素治疗后，抑郁和焦虑均显著改善，两种治疗条件之间的变化程度无显著差异。然而，裸盖菇素治疗后的抗抑郁效果大小较大（'= 1.02-2.27），而安慰剂治疗后的效果大小较小（'= 0.65-0.99），并且在给予裸盖菇素后有很高的反应率（66.7%）和缓解率（46.7%）。裸盖菇素治疗后的抗抑郁作用平均持续 2 个月，与情绪相关的生活质量领域也持续改善。裸盖菇素给药期间的神秘体验强度与随后的抗抑郁效果无关。
这项探索性研究的结果强调了在迷幻辅助心理治疗研究中期望、治疗效果和药物/安慰剂效果之间的复杂相互作用。尽管如此，在给予裸盖菇素后观察到的急性和持续的临床改善支持进一步研究其在治疗重度抑郁症中的潜力。未来的研究应更明确地减轻和衡量期望效应，并评估重复给药和不同形式的心理治疗支持的影响。
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