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Reconsidering evidence for psychedelic-induced psychosis: An overview of reviews, a systematic review, and meta-analysis of human studies

Summary

This research review examined whether people with schizophrenia can safely participate in psychedelic-assisted therapy treatments. Researchers analyzed 131 studies and found that psychedelics rarely cause new psychosis in the general population (0.002%), though the risk is slightly higher in people with existing schizophrenia (3.8%). While the immediate risk appears manageable, about 13% of people who develop psychosis from psychedelics go on to develop schizophrenia, suggesting caution is still needed.

Background

Persons with schizophrenia are currently excluded from psychedelic-assisted therapy due to concerns about psychedelic-induced acute or persistent psychotic symptoms. However, meta-analytic evidence of the precise risk for psychedelic-induced de novo and exacerbation of psychosis in people with pre-existing psychotic disorders is lacking.

Objective

To conduct an overview of reviews, systematic review, and meta-analysis to examine the incidence of psychedelic-induced psychosis and the exacerbation of psychotic symptoms in schizophrenia across multiple psychedelic compounds.

Results

Analysis of 131 publications (14 systematic reviews, 20 reviews, 35 RCTs, 10 case-control studies, 30 uncontrolled trials, and 22 cohort studies) found incidence of psychedelic-induced psychosis was 0.002% in population studies, 0.2% in uncontrolled trials, and 0.6% in RCTs excluding those with psychotic history. In uncontrolled trials including schizophrenia patients, 3.8% developed long-lasting psychotic symptoms, and 13.1% of those with psychedelic-induced psychosis developed schizophrenia.

Conclusion

The incidence of psychedelic-induced psychosis is low but slightly higher in studies including patients with schizophrenia. Schizophrenia might not be a definite exclusion criterion for clinical trials exploring safety and efficacy of psychedelics for treatment-resistant depression. However, more high-quality research is needed before proceeding with clinical implementation.
  • Published in:European Psychiatry,
  • Study Type:Meta-analysis, Systematic Review, Overview of Reviews,
  • Source: 10.1192/j.eurpsy.2025.710
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