Psilocybin as a model of psychotic illness

This phase I human pharmacology trial (n=40), sponsored by the National Institute of Mental Health in the Czech Republic, investigates the effects of psilocybin on brain connectivity in a pharmacological model of psychosis. The trial involves healthy volunteers aged 18 to 65, excluding pregnant women and those with certain medical conditions.

Psilocybin, administered orally, will be compared to a placebo in a double-blind, crossover design. The primary endpoints include changes in regional brain activity, cognitive activation, EEG spectra, and neuropsychiatric test results. The trial aims to correlate these findings with the neurobiology of schizophrenia, providing implications for treatment. The study began in 2014 and concluded in December 2016.

Topic Healthy Subjects
Compound Psilocybin
Country Czech Republic
Visit trial
Status Active, not recruiting
Results Published Yes
Start date 01 January 2014
End date 01 December 2016
Chance of happening 100%
Phase Phase I Phase II
Design Blinded
Type Interventional
Generation First
Participants 40
Sex All
Age 18- 64
Therapy No

Trial Details

The aim of the project is the study of functional brain connectivity in pharmacological model of psychosis induced by acute administration of psilocybin. Brain connectivity under resting condition and during activation tasks will be studied using functional magnetic resonance imaging (fMRI) and quantitative electroencephalography (qEEG) and correlated with psychopathological changes.

NCT Number EudraCT Number: 2012-004579-37

Sponsors & Collaborators

National Institute of Mental Health
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Data attribution

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