Psilocybin in Functional Neurological Disorder (NCT05723276) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Psilocybin in Functional Neurological Disorder
United Kingdom24 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 range25 Years – 60 Years
SexALL
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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.
✕. 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.
What they're measuring
1
Change in functional connectivity in default mode network
Timeframe: One week prior dosing versus one week post dosing (intra-subject)
✕. Diagnosis of any dementia (defined as meeting DSM-5 criteria for any dementia disorder) based on clinical interview by a psychiatrist.
✕. 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