This open-label, Phase Ib clinical trial (n=50) will investigate the safety, feasibility, and tolerability of a single dose of oral psilocybin (25 mg) in individuals with functional impairment due to psychiatric symptoms, including mood, anxiety, trauma, or addiction.
Phase 1b, open-label, single-arm trial assessing safety, feasibility and tolerability of a single oral 25 mg dose of psilocybin in people with psychiatric symptom-related functional impairment; DSM-5 diagnosis is not required and comorbidity is permitted to mirror real-world complexity.
All participants receive one dosing session with non-directive psychological support before, during, and after administration; follow-up assessments occur at 1, 4, and 6 weeks, with optional long-term follow-up at 3, 6, and 12 months.
Safety evaluations include C-SSRS, vitals, ECG, laboratory tests, and adverse event monitoring at acute and follow-up visits; descriptive analyses will summarise safety and feasibility outcomes, screening failure and dropout rates.
Single treatment arm: one oral dose of psilocybin 25 mg with non-directive support before, during, and after dosing.
Opaque size 2 gelatin capsule administered with ~180 ml water at dosing visit.