CompletedNot Applicable

Psilocybin in Functional Neurological Disorder

United Kingdom20 participantsStarted 2024-02-14

Plain-language summary

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?

Who can participate

Age range

25 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 25 - 60 years.
. Fluent in the English language
. A diagnosis of FND from a neurologist and/or neuropsychiatrist as per DSM-5 criteria
. Moderate or severe symptoms (≥4 on Clinical Global Impression Severity (CGI-S) scale) which have been present for \>12 months and have failed to respond to best available treatment.
. Able to tolerate fMRI scanning procedures.

Exclusion criteria

. Diagnosis of severe depression (defined as meeting DSM-5 criteria) on the MINI 7.0. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in functional connectivity in default mode network

Timeframe: One week prior dosing versus one week post dosing (intra-subject)

Trial details

NCT IDNCT05723276

SponsorKing's College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-14

View on ClinicalTrials.gov More Functional Neurological Disorder trials