Parkinson's disease
Conditions
Interventions
Psilocybin is a serotonin 2A receptor agonists. Ketamine is a glutamate
receptor (NMDA) antagonist. Effects are expected to last up to 4 hours.
Participants will receive three doses of psilocybin (5
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter will be a (statistically significant) change in a subjective parameters (mood) after treatment with low doses of psilocybin and ketamine compared to placebo treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters are to is to investigate the effects of repeated low doses of psilocybin and ketamine on [1] well-being, [2] (emotional) attention, [3] neuroplasticity, [4] cognitive performance measures of memory and executive functioning, known to be impaired in Parkinson*s disease (computer tasks), [5] emotion regulation, [6] Parkinson*s symptoms, and [7] biological markers of wellbeing (microbiome, immune system, cortisol). A tertiary parameter is to investigate the effects of repeated low doses of psilocybin on and ketamine the endocannabinoid system, by measuring endocannabinoid concentrations (AEA and 2-AG) in blood plasma. | — |
Countries
Netherlands
Outcome results
None listed