Randomised, parallel-group Phase II trial (n=30) comparing immediate vs delayed point-of-care psilocybin for treatment-resistant depression; single dosing with up to two repeat doses permitted for relapse.
This randomised, parallel-group study evaluates feasibility, safety, and efficacy of point-of-care psilocybin in adults with treatment-resistant depression (MDD or bipolar II).
Participants receive a single dose of psilocybin and are assessed weekly for six weeks then biweekly to 18 weeks; those who relapse may receive up to two repeat doses. Primary outcome is feasibility; secondary outcomes include depressive symptom change and tolerability.
Safety monitoring includes tracking suicidal thoughts and behaviour, adverse events, vital signs, ECG and laboratory tests; exclusion criteria screen for personal or family history of psychosis and recent substance or medical risks.
Participants commence psilocybin treatment immediately upon enrollment.
Single dose at point-of-care; participants who relapse may receive up to two repeat doses (total up to 3).
Participants commence psilocybin treatment two weeks after enrollment (delayed/waitlist comparator).
Single dose at point-of-care; participants who relapse may receive up to two repeat doses (total up to 3).