Parkinson's disease
Conditions
Interventions
Product Name: Psilocybin
Pharmaceutical Form: Capsule
INN or Proposed INN: Psilocybine
CAS Number: 520-52-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharm
Sponsors
Maastricht University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - At least 18 years of age - Being diagnosed with Parkinson’s disease, and able to provide evidence for this (e.g., letter from a medical doctor or DaT-scan) - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Previous experience of serious side effects to psychedelic drugs (anxiety or panic attacks) - Use of conventional Parkinson’s disease medication (i.e., Levodopa, dopamine agonist, amantadine, adenosine a2a antagonist, COMT inhibitors, anticholinergic drugs, MAO inhibitors) - Use of other psychiatric medication - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to investigate the effects of repeated small doses of psilocybin and ketamine on affect (self-rated).;Secondary Objective: Secondary objectives are to investigate the effects of repeated small doses of psilocybin and ketamine on [1] well-being, [2] emotional and cognitive attention (computer tasks), [3] biological markers of neuroplasticity, [4] cognitive performance measures of memory and executive functioning (computer tasks), known to be impaired in Parkinson’s disease and [5] emotion regulation, [6] Parkinson’s disease symptoms, [6] biological markers of well-being (microbiome, immune system, cortisol). A tertiary objective includes investigating the effect of repeated small doses of psilocybin and ketamine on the endocannabinoid concentrations in blood samples. ;Primary end point(s): Change in negative and positive affect scores between at the end of the treatment compared to baseline. ;Timepoint(s) of evaluation of this end point: After completing all three treatment conditions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in quality of life, (emotional) attention, neuroplasticity, emotion regulation, psychological symptom severity, executive functioning, memory performance, Parkinson's disease symptom severity and immune markers at the end of the treatment compared to baseline. ;Timepoint(s) of evaluation of this end point: After completing all three treatment conditions. | — |
Countries
Netherlands
Contacts
Public ContactStudy coordinator
Maastricht University
Outcome results
None listed