Functional Neurological DisorderPsiFUNDNCT05723276
Psilocybin in Functional Neurological Disorder
A study testing Psilocybin in people with Functional Neurological Disorder, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Functional Neurological Disorder
- What is being tested?
- Psilocybin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Feb 2024to 7 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
- 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 7.0. 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 7.0. 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.
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- Diagnosis of any autistic spectrum disorder (defined as meeting DSM-5 criteria for any dementia disorder) based on clinical interview by a psychiatrist.
- Diagnosis of any learning disability (defined as meeting DSM-5 criteria for any dementia disorder) based on clinical interview by a psychiatrist
- Significant suicidal behaviour in past 12-months defined using the Columbia-Suicide Severity Rating Scale (C-SSRS) and confirmation based on clinical interview by a psychiatrist
- 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.
- Those unable to give informed consent
- Medical diagnosis incompatible with psilocybin treatment (see Section 8.2.1)
- Inability to provide a screening blood sample, urine sample or electrocardiogram.
- 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.
- Electrocardiographic abnormalities, defined as any abnormality that is not normal sinus rhythm and determined as clinically significant by a medical doctor.
- Women of childbearing potential not using contraception.
- Pregnant or breast-feeding women.
- Non-registration with a GP or failure to consent to sharing of the GP summary care record and any psychiatric assessments held.
- Those enrolled in another clinical or research study.
- Use of any psychedelic substances >2 times in past 12 months.
- Any factor which would exclude the participant from magnetic resonance imaging (e.g., presence of metal)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
South London and Maudsley NHS Foundation Trust
London
About this study
Official title: Probing the Functional Magnetic Resonance Imaging Response to Psilocybin in Functional Neurological Disorder (PsiFUND)
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?
- Conditions
- Functional Neurological Disorder
- Being tested
- Psilocybin
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Psilocybin 25mg PO
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Psilocybin with therapeutic support Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional connectivity in default mode network
Measured: One week prior dosing versus one week post dosing (intra-subject)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start14 Feb 2024
- Primary completion14 Apr 2026
- Study completion7 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Neurological DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723276
- Sponsor's protocol ID
- TBC
- Acronym
- PsiFUND
- Status last verified
- Jul 2026
- First submitted
- 3 Feb 2023
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probing the Functional Magnetic Resonance Imaging Response to Psilocybin in Functional Neurological Disorder (PsiFUND)
- ClinicalTrials.gov ID
- NCT05723276
- Acronym / sponsor ID
- PsiFUND / TBC
- Conditions
- Functional Neurological Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 7 Jul 2026 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Drug: PsilocybinPsilocybin with therapeutic support |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
- 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.
- 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 7.0. 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 7.0. Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinPsilocybin 25mg PO | Drug | Study arm |
Primary outcome
Change in functional connectivity in default mode network
Time frame: One week prior dosing versus one week post dosing (intra-subject)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psilocybin in people with Functional Neurological Disorder, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in functional connectivity in default mode network (time frame: One week prior dosing versus one week post dosing (intra-subject)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.