CANnabidiol for Parkinson’s Disease Psychosis

Registry facts

Study at a glance

Phase

PHASEII

Enrollment

100 (ACTUAL)

Start date

2020-02-12

Sponsor

King's College London [...] 1. King's College London 2. South London and Maudsley NHS Foundation Trust

Design

Not reported

Locations

0

Results record

Not present in registry snapshot

For Part I of the proposed study, it is predicted that: 1. Cannabidiol at doses between 200-800 mg/day will be safe for short-term (6 weeks) use as a treatment in patients with Parkinson’s disease psychosis 2. A dose of 800 mg/day of cannabidiol will be the maximum tolerated dose in patients with Parkinson’s disease psychosis 3. There will be a minimal effect of short-term (6 weeks) cannabidiol treatment (at doses between 200 to 800 mg/day) on levels of medications such as quetiapine and donepezil in peripheral blood (drug-drug interaction) Based on the results of Part I, the researchers will identify a safe and tolerated dose of cannabidiol to test in Part II of the study. For Part II of the proposed study, it is predicted that: 1. The dose of cannabidiol chosen based on Part I of the study will be safe over a 12-week period of treatment in patients with Parkinson’s disease psychosis 2. The dose of cannabidiol chosen based on Part I of the study will show evidence of activity on measures of psychosis in patients with Parkinson’s disease psychosis (pharmacodynamic signal) For the mechanistic sub-study, it is predicted that: 1. Presence of psychosis in Parkinson’s disease patients would be associated with altered brain function in the striatum and medial temporal, prefrontal and visual cortices and functional connectivity between those regions as measured using MRI 2. 12-week treatment with cannabidiol would normalise those brain functional and connectivity alterations present at baseline (pre-treatment) in Parkinson’s disease patients with psychosis