Psilocybin in Functional Neurological Disorder (PsiFUND)

This open-label trial (n=24) aims to investigate the impact of a single dose of psilocybin (25mg), administered with therapeutic support, on the default mode network (DMN) in individuals with Functional Neurological Disorder (FND).

The study is conducted by King’s College London, with an estimated start date in January 2024 and an estimated completion date in January 2026. The primary goal is to determine whether the default mode network, implicated in FND, can be modified by psilocybin, as assessed through functional magnetic resonance imaging (fMRI).

The trial anticipates enrolling 24 participants aged 25 to 60, diagnosed with FND and experiencing moderate or severe symptoms for over 12 months, unresponsive to previous treatments. Exclusion criteria include severe depression, bipolar affective disorder, psychotic disorder, substance or alcohol dependence disorder, personality disorder, dementia, autistic spectrum disorder, learning disability, significant suicidal behaviour, and other factors unsuitable for psilocybin treatment.

The study design involves a single-group assignment with an open-label approach, and participants will receive psilocybin 25mg orally. The primary outcome measure is the change in functional connectivity in the default mode network, assessed one week before and after dosing. The study is led by King’s College London and has not yet published any general publications related to its results. The trial was first submitted to ClinicalTrials.gov on February 3, 2023, and the last update meeting quality control criteria was on October 2, 2023.

Trial Details

The goal of this study is to learn about the brain network response in people who have functional neurological disorder who are administered with a single dose of the psychedelic psilocybin with therapeutic support. The main question it aims to answer is: Can the default mode network, a brain network thought to be relevent in FND, be modified by the administration of psilocybin based on functional magnetic resonance imaging before and after the dose?

NCT Number NCT05723276

Data attribution

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