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Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication

Summary

Researchers tested whether people with severe depression could take psilocybin (a compound from certain mushrooms) while staying on their antidepressant medications. In this study of 19 people, those who received psilocybin with psychological support while continuing their SSRI showed significant improvement in depression symptoms over three weeks, with response rates of 42%. Side effects were mostly mild and temporary, suggesting this approach may be safe and effective without requiring patients to stop their current antidepressants.

Background

Psilocybin demonstrates antidepressant properties in clinical trials for treatment-resistant depression (TRD). Previous trials typically required withdrawal from serotonergic antidepressants due to concerns about altered psychedelic effects, but recent evidence suggests this may not be necessary.

Objective

To investigate the safety, tolerability, and efficacy of synthetic psilocybin (COMP360) as adjunctive therapy with selective serotonin reuptake inhibitors (SSRIs) in participants with treatment-resistant depression.

Results

Mean MADRS score change from baseline to Week 3 was −14.9 points. Response and remission rates were both 42.1% at Week 3. Treatment-emergent adverse events occurred in 12 participants (63.2%), mostly mild and resolving on Day 1. No serious adverse events or increased suicidal ideation were observed.

Conclusion

Single-dose psilocybin adjunctive to SSRI demonstrated favorable safety profile and therapeutic efficacy in TRD participants, suggesting that antidepressant withdrawal may not be necessary for psilocybin treatment to be effective. Larger comparator-controlled trials are needed to confirm these findings.
  • Published in:Neuropsychopharmacology,
  • Study Type:Clinical Trial,
  • Source: PMID: 37443386, DOI: 10.1038/s41386-023-01648-7
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