Clinical TrialNeuroimaging & Brain MeasuresPsilocybinActive not recruiting

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).

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Target Enrollment
24 participants
Study Type
Phase NA interventional
Design
Non-randomized

Detailed Description

Open-label, single-group basic-science study administering a single 25 mg oral dose of psilocybin with therapeutic support to 24 adults with FND, with pre- and post-dose fMRI.

Primary outcome is change in default mode network connectivity on fMRI; additional assessments include CGI-S, safety/tolerability and ability to tolerate MRI procedures.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin

experimental

Single 25 mg oral psilocybin with therapeutic support.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Therapeutic support provided.

Participants

Ages
25 – 60
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 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

  • Exclusion Criteria:
  • 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 (C-SSRS) 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)

Study Protocol, Arms & Participants

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Study Details

  • Status
    Active not recruiting
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment24 participants
  • Timeline
    Start: 2024-01-01
    End: 2026-01-01
  • Compound
    Psilocybin
  • Topic
    Neuroimaging & Brain Measures

Study Team

Sponsors & Collaborators

Locations

South London and Maudsley NHS Foundation Trust — London, United Kingdom

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