PsiFUND
Overview
Probing the functional magnetic resonance imaging response to psilocybin in functional neurological disorder (PsiFUND)
Now recruiting!
What is the study?
The purpose of this study is to determine whether the psychedelic substance psilocybin changes brain activity in functional neurological disorder. We will measure this using functional magnetic resonance imaging (fMRI) before and after a single dose of psilocybin.
In doing this, we hope to better understand the brain activity signals seen in FND. Increased understand may help to guide us to investigate new treatments in future.
The study has received ethical approval and will be conducted at King’s College London.
Can I take part?
We are actively seeking participants aged 25-60 who have a diagnosis of FND which has not responded to at least one form of recommended treatment.
You do not have to take part and if you decide not to your care and treatment will not be affected in any way.
Are you interested in taking part in this study?
Planned end date
01 Aug 2025 10:19Conditions
Neurological DisordersInclusion Criteria
The following inclusion criteria will apply:
1) Age 25 - 60 years.
2) Fluent in the English language
3) A diagnosis of FND from a neurologist and/or neuropsychiatrist as per DSM-5 criteria
4) 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.
5) 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
The following exclusion criteria will apply:
1) 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.
2) Diagnosis of bipolar affective disorder (defined as meeting DSM-5 criteria for bipolar I or bipolar II) on the MINI 7.0. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist.
3) 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.
4) Diagnosis of drug or alcohol dependence disorder (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.
5) Diagnosis of a personality disorder (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.
6) Diagnosis of any dementia (defined as meeting DSM-5 criteria for any dementia disorder) based on clinical interview by a psychiatrist.
7) Diagnosis of any autistic spectrum disorder (defined as meeting DSM-5 criteria for any dementia disorder) based on clinical interview by a psychiatrist.
8) Diagnosis of any learning disability (defined as meeting DSM-5 criteria for any dementia disorder) based on clinical interview by a psychiatrist
9) Significant suicidal behaviour in past 12-months defined using the Columbia-Suicide Severity Rating Scale (CSSRS) and confirmation based on clinical interview by a psychiatrist
10) Any other factor which would render the participant unsuitable for psilocybin and/or interfere with a supportive therapeutic relationship and/or preclude safe follow-up.
11) Those unable to give informed consent
12) Medical diagnosis incompatible with psilocybin treatment (see Section 8.2.1)
13) Inability to provide a screening blood sample, urine sample or electrocardiogram.
14) Biochemical abnormalities (defined as falling outside the normal reference range) as evaluated by a full blood count, full biochemistry profile and thyroid function tests. Biochemical abnormalities must also be determined as clinically significant by a medical doctor to fulfil the criterion for exclusion.
15) Electrocardiographic abnormalities, defined as any abnormality that is not normal sinus rhythm and determined as clinically significant by a medical doctor.
16) Women of childbearing potential not using contraception.
17) Pregnant or breast-feeding women.
18) Non-registration with a GP or failure to consent to sharing of the GP summary care record and any psychiatric assessments held.
19) Those enrolled in another clinical or research study.
20) Use of any psychedelic substances >2 times in past 12 months.
21) Any factor which would exclude the participant from magnetic resonance imaging (e.g., presence of metal)
To be eligible for this study participants will need, in addition to satisfying the eligibility criteria, to agree to the following:
1) Provide contact details of a trusted friend or relative that the study team may contact in the event of an emergency.
2) To stay within the boundaries of the King’s Clinical Research Facility during the Dosing Visit (the day of treatment) for at least 6 hours after the psilocybin is given, or until it is clinically determined that they are safe to leave, whichever is longer.
