NL-OMON52045撤回2 期
A study to investigate the effects of repeated low doses of psilocybin and ketamine on cognitive and emotional dysfunctions in Parkinson*s disease and to understand its mechanism of action - Microdosing and Parkinson*s disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- At least 18 years of age
- •- Being diagnosed with Parkinson*s Disease
- •- Underwent a DAT scan as part of the diagnostic process
- •- Being able to provide details about the duration of the disease or provide
- •medical records
- •- Free from conventional Parkinson medication (i.e., Levodopa, dopamine
- •agonist, amantadine, adenosine a2a antagonist, COMT inhibitors, anticholinergic
- •drugs, MAO inhibitors)
- •- The participant is, in the opinion of the investigator, generally healthy
- •based on assessment of medical history, physical examination, vital signs,
- •electrocardiogram (ECG), and the results of the haematology, clinical
- •chemistry, urinalysis, serology, and other laboratory tests
- •- A resting pulse and heart rate (as read on the ECG) *51 bpm and *100 bpm. For
- •participants in good physical condition, the lower limit is *45 bpm.
- •- A resting systolic blood pressure *91 mmHg and *140 mmHg and a resting
- •diastolic blood pressure *51 mmHg and *90 mmHg.
- •- Clinical laboratory test values within clinical reference ranges at
- •screening. Borderline values may be accepted if they are, in the opinion of the
- •investigator, clinically insignificant.
- •- Normal binocular visual acuity, corrected or uncorrected
- •- Absence of any major medical, endocrine and neurological condition (apart
- •from Parkinson*s disease), as determined by the medical history, medical
- •examination, electrocardiogram and laboratory analyses (haematology, clinical
- •chemistry, urinalysis, serology).
- •- Normal weight, body mass index (weight/height2) between 19,5 and 28 kg/m2
- •- Being able to communicate in Dutch or English
- •- Written informed consent
排除标准
- •- Previous experience of serious side effects to psychedelic drugs (anxiety or
- •panic attacks)
- •- Use of conventional Parkinson*s disease medication or other psychiatric
- •medication (i.e., Levodopa, dopamine agonist, amantadine, adenosine a2a
- •antagonist, COMT inhibitors, anticholinergic drugs, MAO inhibitors)
- •- History of drug addiction (determined by the medical questionnaire, drug
- •questionnaire and medical examination)
- •- Depression or dementia
- •- Excessive alcohol consumption (>20 units a week)
- •- Excessive smoking (>20 cigarettes a week)
- •- Current or history of psychiatric disorder (determined by the medical
- •questionnaire and medical examination)
- •- Hypertension (diastolic >90; systolic >140)
- •- Liver dysfunction
- •- History of cardiac dysfunctions (arrhythmia, ischemic heart disease, etc)
- •- Pregnancy or lactation
- •- For women of childbearing potential: absence of reliable contraceptive
- •- Experience with a full dose of a psychedelic within the last three months
研究者
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