A study to investigate the effects of repeated... — Clinical Trial Details

This therapeutic exploratory randomised double-blind crossover trial tests repeated low-dose oral psilocybin and ketamine versus placebo in people with Parkinson’s disease to evaluate changes in positive and negative affect and related cognitive and biological outcomes.

Secondary outcomes include well-being, emotional and cognitive attention (computer tasks), neuroplasticity biomarkers, memory and executive function measures, emotion regulation, Parkinson’s symptom severity, microbiome and immune markers, and endocannabinoid concentrations.

Single-site in the Netherlands; participants were adults (including older adults). The primary endpoint is change in affect scores after completing all three treatment conditions.

At least 18 years of age.
Diagnosed with Parkinson’s disease with evidence (e.g., letter from a medical doctor or DaT-scan).
Underwent a DaT scan as part of the diagnostic process.
Able to provide details about disease duration or medical records.
Free from conventional Parkinson medication (e.g., Levodopa, dopamine agonist, amantadine, adenosine A2A antagonist, COMT inhibitors, anticholinergic drugs, MAO inhibitors).
Generally healthy per investigator assessment (medical history, exam, vitals, ECG, haematology, clinical chemistry, urinalysis, serology).
Resting pulse/heart rate ≥51 bpm and ≤100 bpm (≥45 bpm for fit participants).
Resting systolic BP ≥91 mmHg and ≤140 mmHg; diastolic BP ≥51 mmHg and ≤90 mmHg.
Clinical laboratory values within reference ranges or clinically insignificant if borderline.
Normal binocular visual acuity (corrected or uncorrected).
BMI between 19.5 and 28 kg/m2.
Able to communicate in Dutch or English.
Written informed consent.

Previous serious adverse reaction to psychedelic drugs (e.g., severe anxiety or panic attacks).
Use of conventional Parkinson’s disease medication.
Use of other psychiatric medication.
History of drug addiction per medical/drug questionnaires and exam.
Depression or dementia.
Excessive alcohol consumption (>20 units/week).
Excessive smoking (>20 cigarettes/week).
Current or past psychiatric disorder per medical questionnaire and exam.
Hypertension (diastolic >90 mmHg; systolic >140 mmHg).
Liver dysfunction.
History of cardiac dysfunction (arrhythmia, ischaemic heart disease, etc.).
Pregnancy or lactation.

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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

Detailed Description

Study Arms & Interventions

Psilocybin low-dose

Interventions

Ketamine low-dose

Locations

Interventions

Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details