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 actio
- Conditions
- Parkinson's disease10029305
- Registration Number
- NL-OMON52045
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 34
- 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
- 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
measures
- Experience with a full dose of a psychedelic within the last three months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameter will be a (statistically significant) change in a<br /><br>subjective parameters (mood) after treatment with low doses of psilocybin and<br /><br>ketamine compared to placebo treatment. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters are to is to investigate the effects of repeated low doses<br /><br>of psilocybin and ketamine on [1] well-being, [2] (emotional) attention, [3]<br /><br>neuroplasticity, [4] cognitive performance measures of memory and executive<br /><br>functioning, known to be impaired in Parkinson*s disease (computer tasks), [5]<br /><br>emotion regulation, [6] Parkinson*s symptoms, and [7] biological markers of<br /><br>wellbeing (microbiome, immune system, cortisol).<br /><br>A tertiary parameter is to investigate the effects of repeated low doses of<br /><br>psilocybin on and ketamine the endocannabinoid system, by measuring<br /><br>endocannabinoid concentrations (AEA and 2-AG) in blood plasma. </p><br>