E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective is to investigate the effects of repeated small doses of psilocybin and ketamine on affect (self-rated). |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in negative and positive affect scores between at the end of the treatment compared to baseline. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After completing all three treatment conditions. |
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E.5.2 | 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. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
After completing all three treatment conditions. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |