Clinical TrialNeuroimaging & Brain MeasuresPsilocybinPlaceboCompleted

Animal and human serotonergic model of schizophrenia: validity evaluated by qEEG and fMRI

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.

Target Enrollment
40 participants
Study Type
Phase I/II interventional
Design
Randomized, double Blind

Detailed Description

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.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Psilocybin

experimental

Single oral psilocybin dose in crossover vs placebo.

Interventions

  • Psilocybin18.2 mg
    via Oral• single dose• 1 doses total

    Dose expressed per 70 kg.

Placebo

inactive

Matching capsule placebo, oral.

Interventions

  • Placebo
    via Oral• single dose

    Matching capsule placebo (oral).

Participants

Ages
28 – 65
Sexes
Male & Female

Inclusion Criteria

  • Men and women aged 28–65 years
  • Healthy volunteers with negative psychiatric history (no severe mental illnesses meeting ICD‑10 F0.x–F99.x)
  • Negative family psychiatric history for psychosis up to 2nd‑degree relatives
  • No harmful use, abuse or addiction to addictive substances
  • Able to give informed consent

Exclusion Criteria

  • Pregnancy or breastfeeding
  • Intracranial hypertension, severe arterial hypertension or pulmonary hypertension
  • History of stroke
  • Congestive heart failure
  • Presence of a pacemaker
  • Metal clamp or other incompatible metal in head/face
  • Celiac disease
  • Left‑handed volunteers
  • Regular medication use (except hormonal contraception)
  • Persons in dependent positions (undergraduate medical students or other students under 28 years)

Study Details

Locations

Czechia

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