Psilocybin-assisted physiotherapy for refractory Functional Neurological Disorder
- Conditions
- Functional neurological disorderMental Health - Other mental health disordersNeurological - Other neurological disorders
- Registration Number
- ACTRN12621000578808
- Lead Sponsor
- Austin Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Adults aged 18 to 65 years with a diagnosis of refractory motor FND. The diagnosis must be supported by relevant neurological investigations and independent assessment by a psychiatrist and neurologist. Refractory motor FND is defined as upper or lower limb motor weakness, gait disorder or movement disorder (e.g. tremor) of at least 6 months duration.
Participants must have previously received physiotherapy and psychiatry management.
Participants must demonstrate an understanding of their diagnosis of FND and capacity to provide informed consent for the study.
--- Medical exclusion criteria ---
Cardiovascular conditions: poorly-controlled hypertension, angina, ischemic heart disease, a clinically significant ECG abnormality (e.g. atrial fibrillation), transient ischemic attack (TIA), stroke, peripheral or pulmonary vascular disease (no active claudication).
A diagnosis of epilepsy or previous seizures.
A diagnosis of dementia.
A history of Chronic Kidney Disease or Chronic Liver Disease
Known conditions putting the participant at risk for hypercalcaemia, Cushing's syndrome, hypoglycaemia, syndrome of inappropriate antidiuretic hormone secretion, or carcinoid syndrome.
Insulin-dependent diabetes; if taking oral hypoglycaemic agents, the participant is only excluded if they also have a history of hypoglycaemia.
Females who are pregnant, nursing or trying to conceive.
Use of medications contraindicated with psilocybin, that are inappropriate to cease for the necessary time period before/after the dosing session.
Patients enrolled in another clinical trial involving an investigational product.
--- Psychological exclusion criteria ---
Current or previous diagnosis of any psychotic disorder, including Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Brief Psychotic Disorder, Delusional Disorder, Schizotypal Personality Disorder, Substance/Medication-Induced Psychotic Disorder or Psychotic Disorder due to another medical condition.
Current or previous diagnosis of Bipolar I or II disorder.
First degree relative with diagnosed Schizophrenia, Psychotic Disorder, or Bipolar I or II Disorder.
A history of attempted suicide or mania.
Current or previous diagnosis of substance use disorder (excluding caffeine and nicotine).
Previous regular use, or current use of psychedelic agents.
Current diagnosis of other psychiatric conditions judged to be incompatible with safe exposure to psilocybin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method