This randomised, double-blind, placebo-controlled trial (n=0, withdrawn) aimed to assess the efficacy of micro-dosed psilocybin (PSIL428) in reducing anxiety and/or depression levels in adults.
Randomized, double-blind, parallel 16-week study (first 8 weeks double-blind PSIL428 vs placebo; weeks 9–16 open-label PSIL428) evaluating micro-dosed psilocybin (PSIL428, 1 mg) for adults with anxiety and/or depression symptoms.
Primary outcome is change in anxiety and/or depression from baseline to week 16 measured by Beck Anxiety Inventory and Beck Depression Inventory (bi-weekly); safety assessed via labs and adverse events.
Micro-dosed psilocybin (PSIL428), 1 mg, double-blind intervention arm (weeks 1–8).
Microdose regimen; 1 mg psilocybin (per registry)
Placebo comparator using oyster mushroom 1 mg (double-blind).
Oyster mushroom 1 mg used as placebo control
Open-label single-group PSIL428 phase (weeks 9–16) where all participants receive PSIL428.
Open-label PSIL428 1 mg during weeks 9–16