Safety and Efficacy of Psilocybin During Anticancer Treatment: A Phase II Trial Secondary Analysis.

Abstract

<h4>Context</h4>Psilocybin-assisted therapy has demonstrated rapid antidepressant effects in patients with cancer, but most trials have excluded individuals receiving active systemic anticancer treatment, limiting safety data in this population.<h4>Objectives</h4>To compare the efficacy and safety of psilocybin-assisted therapy in patients receiving versus not receiving concurrent systemic anticancer treatment.<h4>Methods</h4>This secondary analysis used data from a phase 2, open-label, single-arm trial (NCT04593563). Adults with malignant neoplasms and DSM-5-diagnosed major depressive disorder received individual and group preparation therapy, a single 25-mg oral psilocybin group dosing session, and individual and group integration therapy. Active systemic anticancer treatment was defined as receipt of systemic therapy within 30 days of psilocybin dosing (systemic treatment, n = 17; no systemic treatment, n = 13). The primary outcome was between-group difference in Montgomery-Åsberg Depression Rating Scale (MADRS) scores at weeks 1, 3, and 8; secondary outcomes included adverse events (AEs), severity, and timing through week 8.<h4>Results</h4>Among 30 participants (mean [SD] age, 56 [12] years; 21 women [70%]), MADRS scores decreased substantially in both groups, with no significant between-group differences at week 1 (P = .88), week 3 (P = .93), or week 8 (P = .97). AEs were frequent in both groups (mean per participant, 9.0 vs 6.7; P = .08). Four severe AEs and one serious AE occurred, all in systemic treatment recipients, but were deemed unrelated to psilocybin. No significant laboratory or suicidality changes attributable to psilocybin were observed.<h4>Conclusion</h4>Psilocybin-assisted therapy had comparable antidepressant outcomes and a similar safety profile in cancer patients regardless of systemic anticancer treatment status, supporting inclusion of actively treated oncology populations in future psilocybin trials.

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