Psilocybin for Hospitalized Patients With Treatment-resistant Depression (PSIHOS-D)

Open-label single-group feasibility study in patients hospitalised for treatment-resistant depression assessing safety, feasibility and preliminary clinical and neurological outcomes of psilocybin-assisted psychotherapy.

Intervention comprises two 25 mg oral psilocybin sessions (week 3 and week 6) with five preparatory psychotherapy sessions (total 7.5 hours) and six integration sessions (total 9 hours), delivered by the same two therapists.

Assessments include questionnaires at regular intervals, EEG before each dosing and during follow-up, urine drug screens and pregnancy tests on dosing mornings, and semi-structured interviews at hospital admission and discharge.

Partners are involved in selected sessions, EEGs and follow-up contacts; outpatient follow-up continues to 12 weeks post-last dose with optional naturalistic follow-up to 1 year.