The Impact of Different Concentrations of Hemp-Derived Cannabidiol (CBD) Full-spectrum Oil Solutions in the Treatment of Depressive and Anxiety Disorders in Parkinson's Disease Patients.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Change in anxiety symptom severity measured by the Beck Anxiety Inventory (BAI)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed Parkinson's Disease according to MDS Clinical Diagnostic Criteria (2015).
- •Disease duration ≥4 years before study inclusion.
- •Age between 40 and 70 years at enrollment.
- •Stable oral medication regimen (including Parkinson's disease medications, antidepressants, and anxiolytics) for at least 1 month prior to inclusion and maintained throughout the study (up to 2 months from inclusion).
- •Moderate or higher anxiety-depressive symptoms at baseline (BDI ≥11 points, BAI ≥16 points)
Exclusion Criteria
- •Dementia or cognitive impairment.
- •Advanced Parkinson's therapy (DBS, infusion pumps, ablation) or planned initiation within study duration (2 months).
- •No caregiver support.
- •Pregnancy, breastfeeding, or lack of contraception in women of childbearing potential.
- •Neurological or psychiatric disorders affecting evaluation (vascular CNS damage, previous CNS surgery).
- •Musculoskeletal conditions preventing motor assessments.
- •Active malignancy.
- •Cannabinoids use within the last 30 days.
- •Use of hepatotoxic drugs or drugs with potential toxic interaction with CBD (e.g., valproic acid, warfarin, haloperidol) within 90 days prior to inclusion.
- •Paracetamol intake exceeding 1 g/day during study participation
Arms & Interventions
Arm 1: CBD oil 30 mg/day
Intervention type: Dietary Supplement Product description: Full-spectrum CBD oil (2000 mg CBD/30 ml bottle) Dose: 30 mg CBD/day, divided into two doses (15 mg each) Route of administration: Sublingual, administered orally during meals Frequency: Twice daily Duration: 60 days
Intervention: Full-spectrum Cannabidiol (CBD) oil (Dietary Supplement)
Arm 2: CBD oil 60 mg/day
Intervention type: Dietary Supplement Product description: Full-spectrum CBD oil (2000 mg CBD/30 ml bottle) Dose: 60 mg CBD/day, divided into two doses (30 mg each) Route of administration: Sublingual, administered orally during meals Frequency: Twice daily Duration: 60 days
Intervention: Full-spectrum Cannabidiol (CBD) oil (Dietary Supplement)
Arm 3: CBD oil 300 mg/day
Intervention type: Dietary Supplement Product description: Full-spectrum CBD oil (2000 mg CBD/30 ml bottle) Dose: 300 mg CBD/day, divided into two doses (150 mg each) Route of administration: Sublingual, administered orally during meals Frequency: Twice daily Duration: 60 days
Intervention: Full-spectrum Cannabidiol (CBD) oil (Dietary Supplement)
Outcomes
Primary Outcomes
Change in anxiety symptom severity measured by the Beck Anxiety Inventory (BAI)
Time Frame: Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
Anxiety symptom severity will be assessed using the Beck Anxiety Inventory (BAI). The outcome measure is the change in total BAI score from baseline to subsequent assessment time points. Higher scores indicate greater anxiety symptom severity.
Change in depressive symptom severity measured by the Beck Depression Inventory-I (BDI-I)
Time Frame: Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
Depressive symptom severity will be assessed using the Beck Depression Inventory-I (BDI-I). The outcome measure is the change in total BDI-I score from baseline to subsequent assessment time points. Higher scores indicate greater depressive symptom severity.
Secondary Outcomes
- Change in insomnia severity measured by the Athens Insomnia Scale (AIS)(Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up))
- Change in anxiety symptoms measured by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)(Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up))
- Change in depressive symptoms measured by the Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)(Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up))
- Change in depression symptoms measured by the Depression Anxiety Stress Scales - Depression Subscale (DASS-21 Depression)(Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up))
- Change in anxiety symptoms measured by the Depression Anxiety Stress Scales - Anxiety Subscale (DASS-21 Anxiety)(Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up))
- Change in stress symptoms measured by the Depression Anxiety Stress Scales - Stress Subscale (DASS-21 Stress)(Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up))
- Change in psychosis symptom severity measured by the Parkinson Psychosis Questionnaire (PPQ)(Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up))
- Change in life satisfaction measured by the Satisfaction With Life Scale (SWLS)(Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up))
- Change in fatigue measured by the Fatigue Assessment Scale (FAS)(Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up))
- Change in pain severity measured by the Visual Analogue Scale (VAS)(Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up))
- Change in health-related quality of life measured by the Parkinson's Disease Questionnaire (PDQ-39)(Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up))
- Change in sleep-related symptoms measured by the Parkinson's Disease Sleep Scale (PDSS-1)(Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up))
- Change in motor symptom severity measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up))
- Change in non-motor symptom burden measured by the Non-Motor Symptoms Scale (NMSS)(Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up))
- Change in daytime sleepiness measured by the Epworth Sleepiness Scale (ESS)(Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up))
- Change in health-related quality of life measured by the EuroQol-5D (EQ-5D)(Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up))
Investigators
Stanislaw Szlufik
Department of Neurology, Faculty of Health Sciences, Medical University of Warsaw
Medical University of Warsaw