Safety, Tolerability, and Preliminary Efficacy of Psilocybin Oral Solution in Adults With Generalized Anxiety Disorder

Phase 2a design with screening (up to 4 weeks), a 4-week open-label run-in (psilocybin 3 mg daily), then responders randomised 1:1 to 28-day double-blind psilocybin or placebo.

Outcomes include safety and tolerability, preliminary efficacy on GAD-7 and HAM-A, cognitive testing, EEG and patient-reported outcomes; allocation is randomized with quadruple masking.