Parkinson's Disease (PD)
Conditions
Keywords
Parkinson's Disease, Depression, Anxiety Disorders
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.
Interventions
DIETARY_SUPPLEMENTFull-spectrum Cannabidiol (CBD) oil
Participants will receive full-spectrum cannabidiol (CBD) oil, administered orally as a dietary supplement. CBD oil will be delivered sublingually twice daily during meals. Three dosage groups will be studied: 30 mg/day, 60 mg/day, and 300 mg/day. CBD oil used in the study contains 2000 mg CBD per 30 ml bottle. Each participant will receive blinded bottles labeled with unique identifiers, ensuring double-blind administration. The duration of intervention is 60 days, followed by a one-month follow-up period to assess safety and lasting effects after discontinuation.
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety symptom severity measured by the Beck Anxiety Inventory (BAI) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | Insomnia severity will be assessed using the Athens Insomnia Scale (AIS). The outcome measure is the change in total AIS score from baseline to subsequent assessment time points. Higher scores indicate greater insomnia severity. |
| 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) | Anxiety symptoms will be assessed using the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A). The outcome measure is the change in HADS-A score from baseline to subsequent assessment time points. Higher scores indicate greater anxiety symptom severity. |
| 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) | Depressive symptoms will be assessed using the Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D). The outcome measure is the change in HADS-D score from baseline to subsequent assessment time points. Higher scores indicate greater depressive symptom severity. |
| 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) | Depression symptoms will be assessed using the DASS-21 Depression Subscale. The outcome measure is the change in depression subscale score from baseline to subsequent assessment time points. Higher scores indicate greater depressive symptom severity. |
| 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) | Anxiety symptoms will be assessed using the DASS-21 Anxiety Subscale. The outcome measure is the change in anxiety subscale score from baseline to subsequent assessment time points. Higher scores indicate greater anxiety symptom severity. |
| 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) | Stress symptoms will be assessed using the DASS-21 Stress Subscale. The outcome measure is the change in stress subscale score from baseline to subsequent assessment time points. Higher scores indicate greater stress symptom severity. |
| 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) | Psychosis symptoms will be assessed using the Parkinson Psychosis Questionnaire (PPQ). The outcome measure is the change in total PPQ score from baseline to subsequent assessment time points. Higher scores indicate greater frequency and severity of psychotic symptoms. |
| 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) | Life satisfaction will be assessed using the Satisfaction With Life Scale (SWLS). The outcome measure is the change in total SWLS score from baseline to subsequent assessment time points. Higher scores indicate greater life satisfaction. |
| 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) | Fatigue will be assessed using the Fatigue Assessment Scale (FAS). The outcome measure is the change in total FAS score from baseline to subsequent assessment time points. Higher scores indicate greater fatigue. |
| 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) | Pain severity will be assessed using a Visual Analogue Scale (VAS). The outcome measure is the change in pain intensity score from baseline to subsequent assessment time points. Higher scores indicate greater pain severity. |
| 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) | Health-related quality of life will be assessed using the Parkinson's Disease Questionnaire (PDQ-39). The outcome measure is the change in total PDQ-39 score from baseline to subsequent assessment time points. Higher scores indicate poorer health-related quality of life. |
| 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) | Sleep-related symptoms will be assessed using the Parkinson's Disease Sleep Scale (PDSS-1). The outcome measure is the change in total PDSS-1 score from baseline to subsequent assessment time points. Higher scores indicate better sleep quality and fewer sleep-related symptoms. |
| 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) | Motor and non-motor symptom severity will be assessed using the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The outcome measure is the change in total MDS-UPDRS score from baseline to subsequent assessment time points. Higher scores indicate greater disease severity. |
| 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) | Non-motor symptom burden will be assessed using the Non-Motor Symptoms Scale (NMSS). The outcome measure is the change in total NMSS score from baseline to subsequent assessment time points. Higher scores indicate greater non-motor symptom burden. |
| 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) | Daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS). The outcome measure is the change in total ESS score from baseline to subsequent assessment time points. Higher scores indicate greater daytime sleepiness. |
| 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) | Health-related quality of life will be assessed using the EuroQol-5D (EQ-5D). The outcome measure is the change in EQ-5D health status score from baseline to subsequent assessment time points. Higher scores indicate better perceived health status. |
Countries
Poland
Outcome results
None listed