Full-Spectrum Cannabidiol Oil for Anxiety and Depressive Symptoms in Parkinson's Disease

Brief summary (registry, in English)

Parkinson's disease (PD) is a progressive neurodegenerative disorder primarily characterized by motor symptoms such as bradykinesia, rigidity, and tremor. However, non-motor symptoms, particularly anxiety and depression, are also common and substantially affect patients' daily functioning and quality of life. Cannabidiol (CBD), a non-intoxicating constituent of Cannabis sativa, has demonstrated anti-inflammatory, antioxidant, and anxiolytic properties and has shown therapeutic potential in several clinical settings. The aim of this study was to evaluate the efficacy and safety of full-spectrum CBD oil administered at three different doses (30 mg/day, 60 mg/day, and 300 mg/day) as adjunctive therapy for anxiety and depressive symptoms in patients with Parkinson's disease. This randomized, double-blind, dose-ranging clinical trial enrolled 27 participants with Parkinson's disease and moderate anxiety-depressive symptoms. Participants aged 40 to 70 years, diagnosed with Parkinson's disease at least four years before enrollment and presenting with moderate or greater anxiety-depressive symptoms, were randomly assigned in a 1:1:1 ratio to receive full-spectrum CBD oil at doses of 30 mg/day, 60 mg/day, or 300 mg/day for two months. Assessments were conducted at baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up) to evaluate treatment effects and safety after treatment discontinuation. Primary outcomes included changes in anxiety and depression severity measured using the Beck Anxiety Inventory (BAI) and Beck Depression Inventory-I (BDI-I). Secondary and other pre-specified outcomes included assessments of sleep quality, fatigue, cognitive functioning, psychosis symptoms, quality of life, motor and non-motor symptoms of Parkinson's disease, daytime sleepiness, pain, wearable sensor-derived motor assessments, and participant-rated treatment effectiveness. The CBD oils used in the study were prepared under controlled conditions and tested to verify CBD concentration and the absence of contaminants, including heavy metals and mold contamination. Participants were monitored throughout the study for adverse events, including somnolence, fatigue, gastrointestinal symptoms, and potential treatment-related safety concerns. The study evaluated the potential role of CBD as an adjunctive treatment for anxiety and depressive symptoms in Parkinson's disease and assessed the safety and tolerability of different CBD dosing regimens. The duration of participation for each participant was approximately three months, including a two-month treatment period and a one-month follow-up assessment.

What you commit to

• Study type: Interventional · Phase 2
• Participants enrolled: 27
• From 18 Dec 2023 to the primary completion date, 17 Nov 2024
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 40 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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