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The development of psilocybin therapy for treatment-resistant depression: an update

Summary

Psilocybin, a compound found in certain mushrooms, is being studied as a potential treatment for severe depression that doesn’t respond to standard medications. In clinical trials, patients receiving psilocybin alongside psychological support showed significant improvement in depressive symptoms within days to weeks, with benefits lasting for months. Unlike daily antidepressant pills, psilocybin therapy involves one or more carefully supervised dosing sessions in a hospital setting with therapeutic support before and after. Larger studies are underway to confirm its effectiveness and safety before it could potentially become an approved treatment.

Background

Major depressive disorder (MDD) is a leading cause of disability worldwide, with 10-30% of patients meeting criteria for treatment-resistant depression (TRD) and not responding to standard pharmacological treatments. Psilocybin, a classic psychedelic drug, has attracted increasing research interest as a potential treatment option for depression when administered alongside psychological support.

Objective

To provide a comprehensive update to psychiatrists on the development of psilocybin therapy for depression, including what it is, what it is not, current evidence-base, and the state of clinical trials. This review aims to inform clinical practice regarding psilocybin as an emerging treatment for treatment-resistant depression.

Results

Phase 2 clinical trials demonstrated encouraging safety profiles and rapid symptomatic improvement. The largest multi-centre trial (2022) showed 37% response rate at 25 mg dose versus 18% at placebo at 3 weeks. Early evidence indicates single psilocybin doses induce rapid improvement in depressive symptoms within days, with benefits sustained for weeks. Phase 3 trials for TRD were scheduled to begin in 2023.

Conclusion

Psilocybin therapy shows promise for treatment-resistant depression, with preliminary evidence of safety and efficacy, though large-scale phase 3 trials are needed to establish definitive efficacy. If approved, regulatory oversight similar to electroconvulsive therapy may be required, and the therapy would likely target the TRD population.
  • Published in:BJPsych Bulletin,
  • Study Type:Narrative Review,
  • Source: PMID: 37357767, DOI: 10.1192/bjb.2023.25
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