CANnabidiol for Parkinson's Disease Psychosis (CAN-PDP), version 1
Overview
Participants needed: researchers at King’s College London University are currently evaluating an investigational medication called cannabidiol (CBD) to see how safe and how well CBD works in patients with Parkinson’s disease psychosis.
The study will include:
• Twelve weeks of treatment with the study medicine
• Two MRI scans of approximately 60 minutes
• Study-related medical exams and assessments
• Compensation for reasonable costs
In order to be eligible you must:
• be age 40 or older
• have a diagnosis of Parkinson’s disease
• be experiencing symptoms of psychosis (such as delusions or hallucinations)
Are you interested in taking part in this study?
Planned end date
01 Sep 2025 00:00Conditions
Dementia,PsychosisPeople types
Older adultsInclusion Criteria
PDP inclusion criteria:
1. Satisfy established diagnostic criteria (NINDS-NIMH criteria for the diagnosis of Parkinson's disease psychosis) and UK Brian Bank criteria for idiopathic Parkinson's disease.
2. Age 40 or older.
3. For psychotic symptoms, they should have developed after the PD diagnosis and should have been present for at least 1 month, occurring at least weekly over the month before screening and should have a combined score of at least 6 or an individual score of at least 4 on the neuropsychiatric inventory (NPI) A (delusions) and/or B (hallucinations) subscale in the month before screening.
4. Parkinson's disease dementia would not be an exclusion criterion.
5. Participants with score greater than 18 on the Montreal Cognitive Assessment scale.
6. Treatment as usual will include patients on quetiapine and/ or cholinesterase inhibitors (rivastigmine/ donepezil) as well as standard antiparkinsonian treatments with dosage stable for at least 1 month.
7. At least 6 months post stereotaxic surgery (deep brain stimulation) and stimulator settings stable for at least 1 month prior to baseline and must remain stable during the trial.
8. Ability to participate in study evaluation and ingest oral medication.
9. Reliable informant/caregiver.
10. Written informed consent to participate.
Exclusion Criteria
PDP Exclusion criteria:
1. Insufficient understanding of trial.
2. History of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder.
3. Psychotic symptoms secondary to other toxic or metabolic disorders.
4. Psychosis onset after ablative stereotaxic surgery.
5. Diagnosis of dementia made concurrent with or prior to a PD diagnosis.
6. Patients on clozapine due to the requirement of special safety monitoring required for clozapine, which will unblind the safety.
7. Patients taking part in another intervention trial concurrently. However, those withdrawn from another study or who have recently completed another intervention study will be eligible for inclusion if they satisfy study inclusion/ exclusion criteria. For pharmacological intervention, they will be eligible only after a sufficient period of washout (~ 5 times half-life of other study drug).
8. Participant no longer able to report symptoms as a result of cognitive impairment.
9. Presence of depressive symptoms would not be an exclusion criterion. However, we would exclude those participants who may have severe depression.
10. Participants who answer "yes"" on the C-SSRS Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act
