Randomised, double‑blind, placebo‑controlled crossover study (n=40) testing a single oral psilocybin dose (18.2 mg/70 kg) versus placebo in healthy volunteers to model psychosis and assess fMRI/qEEG changes.
This crossover, randomised, double‑blind trial administers a single oral dose of psilocybin and matching placebo to healthy volunteers to model serotonergic psychosis and evaluate brain connectivity using resting and task fMRI and quantitative EEG (qEEG).
Primary outcomes compare regional activity and connectivity changes on fMRI and EEG (LORETA, spectral measures, coherence) between psilocybin and placebo; neuropsychiatric scales (BPRS, ASCs, HRS) will be correlated with imaging findings.
The study is a single‑site EEA CTA sponsored by the National Institute of Mental Health (Czech Republic); planned enrolment per registry was 40 healthy adults.
Single oral psilocybin dose in crossover vs placebo.
Dose expressed per 70 kg.
Matching capsule placebo, oral.
Matching capsule placebo (oral).
In a randomised double-blind crossover study of 20 healthy volunteers, daytime psilocybin prolonged REM sleep latency and tended to reduce REM duration while suppressing slow‑wave activity in the first sleep cycle, without altering NREM macrostructure or whole‑night EEG power. These sleep‑architecture changes may relate to psilocybin’s putative antidepressant effects, although no evidence of sleep‑related neuroplasticity was found.