The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder
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.
Details
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.