Long-Term Efficacy of Psilocybin with Adjunct Psychotherapy in Treatment-Resistant Major Depression (EPIsoDE): 6- and 12-Month Naturalistic Follow-Up of a Phase 2b Trial - PubMed
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- #psilocybin
- #long-term follow-up
- #treatment-resistant depression
- Study examines long-term efficacy of psilocybin with adjunct psychotherapy for treatment-resistant depression (TRD) at 6- and 12-month follow-ups.
- Phase 2b trial included groups receiving different psilocybin doses or active placebo, with psychotherapeutic support; controlled phase ended at 12 weeks.
- Results show significant and sustained reduction in depression scores (HAMD17) at both follow-up time points, with no significant group differences.
- Re-initiation of antidepressant pharmacotherapy during follow-up was associated with higher depression scores, suggesting potential interference with psilocybin's effects.
- Findings support stable, clinically meaningful antidepressant effects of psilocybin therapy up to 12 months in TRD, based on largest psychedelic trial follow-up to date.