Efficacy and tolerability of psilocybin-assisted... — Clinical Trial Details

Randomised parallel Phase I/II single-centre pilot enrolling 24 participants with refractory motor functional neurological disorder; participants receive a single supervised oral psilocybin dose (15 mg or 25 mg) combined with physiotherapy.

Procedures include a pre-dosing mental health preparation session, two physiotherapy preparation sessions, in-session monitoring with vital signs for approximately 5 hours post-dose, and 3-6 follow-up physiotherapy sessions of ~60 minutes each; outcomes include clinician- and participant-rated motor symptom severity and resting-state/task fMRI.

Safety assessed via adverse events and vital signs; treatment fidelity monitored via checklists, participant reports and independent workbook review.

Participants

Ages

18 – 65

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria

Adults aged 18 to 65 years with a diagnosis of refractory motor FND 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 psychiatric management.
Participants must demonstrate understanding of their diagnosis and capacity to provide informed consent.

Exclusion Criteria

Medical exclusion criteria:
Cardiovascular conditions: poorly-controlled hypertension, angina, ischaemic heart disease, a clinically significant ECG abnormality (e.g. atrial fibrillation), transient ischaemic attack (TIA), stroke, peripheral or pulmonary vascular disease.
Diagnosis of epilepsy or previous seizures.
Diagnosis of dementia.
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 (SIADH), or carcinoid syndrome.
Insulin-dependent diabetes; participants on oral hypoglycaemic agents excluded only if they also have a history of hypoglycaemia.
Females who are pregnant, nursing or trying to conceive.
Use of medications contraindicated with psilocybin or that are inappropriate to cease for the necessary time period before/after dosing.
Enrollment in another clinical trial involving an investigational product.
Psychological exclusion criteria:
Current or previous diagnosis of any psychotic disorder (including schizophrenia, schizoaffective disorder, schizotypal personality disorder, delusional 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.
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.

Company

Product

Legal

Efficacy and tolerability of psilocybin-assisted physiotherapy on motor symptoms in refractory Functional Neurological Disorder

Detailed Description

Study Protocol

Preparation

Locations

Dosing

Integration

Therapeutic Protocol

Study Arms & Interventions

Low dose 15 mg

Interventions

Standard dose 25 mg

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details