ACTRN12621000578808招募中1 期
Efficacy and tolerability of psilocybin-assisted physiotherapy on motor symptoms in refractory Functional Neurological Disorder
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •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.
排除标准
- •--- 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
研究者
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