Phase II, single-center, fixed-dose, open-label study (n=30) testing a single 25 mg oral dose of psilocybin in adults with MDD and a malignant neoplasm to assess safety, tolerability and preliminary efficacy.
Single-group Phase II study administering one 25 mg oral psilocybin session with supportive conditions to adults with Major Depressive Disorder and a malignant neoplasm.
Primary outcomes focus on safety and tolerability; depressive symptoms (HAM-D17) and other psychological measures assessed at baseline and follow-ups to explore efficacy signals.
Participants must be antidepressant-free, meet DSM-5 criteria for MDD, have HAM-D17 ≥18, and have an ICD-10 C00–C97 cancer diagnosis; key exclusions include psychosis, bipolar disorder, recent psychedelic use, significant suicide risk, or uncontrolled medical illness.
Single 25 mg oral dose with supportive conditions.
5 × 5 mg capsules (single session)
In interviews with 28 cancer patients with major depressive disorder, a combined model of psilocybin‑assisted simultaneous individual and group therapy was generally judged acceptable and was felt to enhance perceived safety, preparedness, connection and opportunities for self‑transcendence and compassion. Participants emphasised the therapeutic framework, the complementary value of individual sessions, and careful attention to group size and interaction structure as key factors influencing acceptability and scalability in cancer care.