Randomised, double-blind, crossover neuroimaging study (n=67) comparing single doses of psilocybin 2 mg and 5 mg versus placebo in adults with and without Autism Spectrum Disorder to probe serotonin system regulation.
Case-control repeated-measures crossover design: each participant receives placebo, psilocybin 2 mg and psilocybin 5 mg in separate visits; order pseudorandomised and participants/investigators blinded.
Primary outcomes evaluate serotonin-modulated brain responses using multimodal neuroimaging (fMRI, MRS), EEG and sensory tasks with unimodal and multimodal analyses.
Psilocybin (COMP360) is used as a probe of the serotonin system; UK MHRA determined this is not an IMP clinical trial under EU Directive definitions.
Randomised, double-blind, crossover administration of placebo, psilocybin 2 mg and psilocybin 5 mg in separate visits.
COMP360 psilocybin 5 mg.
COMP360 psilocybin 2 mg.
Inactive placebo.