Safety and tolerability of psilocybin-assisted physiotherapy in healthy volunteers

Phase 1

Completed

• Conditions: Functional neurological disorder; Mental Health - Other mental health disorders; Neurological - Other neurological disorders

• Registration Number: ACTRN12621000560897
• Lead Sponsor: Austin Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-12
• Study Completion: 2024-02-28
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Adults aged 18 to 65 years, without a history of Functional Neurological Disorder (FND), who have volunteered for the study.

Capacity to provide informed consent

Exclusion Criteria

--- 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 epileptic seizures.

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 disorder.

First degree relative with diagnosed Schizophrenia, Psychotic Disorder, or Bipolar 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