Probing the Functional Magnetic Resonance Imaging Response to Psilocybin in Functional Neurological Disorder (PsiFUND)

King's College London1 site in 1 country24 target enrollmentFebruary 14, 2024

ConditionsFunctional Neurological Disorder

InterventionsPsilocybin

DrugsPsilocybin

Overview

Phase: N/A
Intervention: Psilocybin
Conditions: Functional Neurological Disorder
Sponsor: King's College London
Enrollment: 24
Locations: 1
Primary Endpoint: Change in functional connectivity in default mode network
Status: Active, Not Recruiting
Last Updated: 15 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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?

Registry

clinicaltrials.gov

Start Date

February 14, 2024

End Date

May 1, 2026

Last Updated

15 days ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

King's College London

Responsible Party

Sponsor

Eligibility Criteria

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.
•Failed to respond is defined as an inadequate response to a full course of FND-specific therapy, including psychological therapy (cognitive behavioural therapy) or physiotherapy. Either therapy must have been undertaken by a suitably trained expert in FND and must have been specifically targeted at FND symptoms.

Exclusion Criteria

•Diagnosis of severe depression (defined as meeting DSM-5 criteria) on the MINI 7.
•Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist.
•Diagnosis of bipolar affective disorder (defined as meeting DSM-5 criteria for bipolar I or bipolar II) on the MINI 7.
•Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist.
•Diagnosis of a psychotic disorder (defined as meeting DSM-5 criteria) on the MINI 7.0, EXCEPT substance/medication induced psychotic disorder where the duration was limited to the acute period of direct intoxication with the substance/medication. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist.
•Diagnosis of drug or alcohol dependence disorder (defined as meeting DSM-5 criteria) on the MINI 7.
•Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist.
•Diagnosis of a personality disorder (defined as meeting DSM-5 criteria) on the MINI 7.
•Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist.
•Diagnosis of any dementia (defined as meeting DSM-5 criteria for any dementia disorder) based on clinical interview by a psychiatrist.