Background

Persons with schizophrenia are excluded from psychedelic-assisted therapy due to concerns about the risk of triggering or worsening psychosis. However, there is limited meta-analytic data on the risk of psychedelic-induced psychosis in individuals with pre-existing psychotic disorders.

Methods

We conducted a systematic review, meta-analysis, and overview of reviews to assess the incidence of psychedelic-induced psychosis and symptom exacerbation in schizophrenia. Our pre-registered protocol (CRD42023399591) covered: LSD, psilocybin, mescaline, DMT, and MDMA, using data from Embase, PubMed, PsyARTICLES, PsyINFO, and trial registries up to November 2023. A random-effects model was used to calculate psychosis incidence, with standardized assessments of study quality.

Results

From 131 publications, we analyzed 14 systematic reviews, 20 reviews, 35 randomized-controlled trials (RCTs), 10 case-control studies, 30 uncontrolled trials (UCTs), and 22 cohort studies, most of which were low quality. Meta-analysis of nine studies showed an incidence of psychedelic-induced psychosis at 0.002% in population studies, 0.2% in UCTs, and 0.6% in RCTs. In UCTs including individuals with schizophrenia, 3.8% developed long-lasting psychotic symptoms. Of those with psychedelic-induced psychosis, 13.1% later developed schizophrenia. Sensitivity analyses confirmed the results.

Conclusion

In summary, the reviewed evidence suggests that schizophrenia might not be a definite exclusion criterion for clinical trials exploring safety and efficacy of psychedelics for treatment-resistant depression and negative symptoms. However, given the low quality and limited number of studies, more high-quality research is needed, and a conservative approach is recommended until further data is available.

中文翻译：

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重新考虑迷幻药诱发的精神病的证据：综述概述、系统评价和人类研究的荟萃分析

 背景

精神分裂症患者由于担心引发精神病或恶化精神病的风险而被排除在迷幻药辅助治疗之外。然而，关于已有精神障碍的个体患迷幻药诱发精神病风险的荟萃分析数据有限。

 方法

我们进行了系统评价、荟萃分析和综述概述，以评估精神分裂症中迷幻药诱导的精神病和症状恶化的发生率。我们的预注册方案 （CRD42023399591） 涵盖：LSD、裸盖菇素、麦斯卡林、DMT 和 MDMA，使用来自 Embase、PubMed、PsyARTICLES、PsyINFO 和试验注册库的数据，截至 2023 年 11 月。使用随机效应模型计算精神病发生率，并对研究质量进行标准化评估。

 结果

从 131 篇出版物中，我们分析了 14 篇系统评价、20 篇综述、35 项随机对照试验 （RCT）、10 项病例对照研究、30 项非对照试验 （UCT） 和 22 项队列研究，其中大多数是低质量的。对 9 项研究的荟萃分析显示，在人群研究中，迷幻药诱导的精神病发生率为 0.002%，在 UCT 中为 0.2%，在 RCT 中为 0.6%。在包括精神分裂症个体在内的 UCT 中，3.8% 出现长期精神病症状。在迷幻药诱发的精神病患者中，13.1% 后来发展为精神分裂症。敏感性分析证实了结果。

 结论

总之，审查的证据表明，精神分裂症可能不是探索迷幻药治疗难治性抑郁症和阴性症状的安全性和有效性的临床试验的明确排除标准。然而，鉴于研究质量低且数量有限，需要更多高质量的研究，在获得更多数据之前，建议采取保守的方法。