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

NCT07651930 | Completed Phase 2

• 1 other identifier: KB/279/2023
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease (PD)

Keywords

Parkinson's Disease; Depression; Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

• Change in anxiety symptom severity measured by the Beck Anxiety Inventory (BAI)

  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.

  Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)

• Change in depressive symptom severity measured by the Beck Depression Inventory-I (BDI-I)

  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.

  Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)

Secondary Outcomes (16)

• 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)

Other Outcomes (3)

• Change in motor activity parameters measured by wearable gyroscopic-magnetometric sensors

  Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)

• Participant-rated perceived treatment effectiveness

  Month 1 and Month 2 (end of treatment)

• Incidence of treatment-emergent adverse events

  Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)

Study Arms (3)

Arm 1: CBD oil 30 mg/day

ACTIVE COMPARATOR

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

Dietary Supplement: Full-spectrum Cannabidiol (CBD) oil

Arm 2: CBD oil 60 mg/day

ACTIVE COMPARATOR

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

Dietary Supplement: Full-spectrum Cannabidiol (CBD) oil

Arm 3: CBD oil 300 mg/day

ACTIVE COMPARATOR

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

Dietary Supplement: Full-spectrum Cannabidiol (CBD) oil

Interventions

Full-spectrum Cannabidiol (CBD) oil DIETARY_SUPPLEMENT

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.

Also known as: CBD oil, Cannabidiol oil

Arm 1: CBD oil 30 mg/day; Arm 2: CBD oil 60 mg/day; Arm 3: CBD oil 300 mg/day

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed Parkinson's Disease according to MDS Clinical Diagnostic Criteria (2015).
• Age between 40 and 70 years at enrollment.
• Moderate or higher anxiety-depressive symptoms at baseline (BDI ≥11 points, BAI ≥16 points)

You may not qualify if:

• 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.
• Paracetamol intake exceeding 1 g/day during study participation

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Neurology, Faculty of Health Sciences, Medical University of Warsaw

Warsaw, Poland

Location

Related Publications (2)

• Schier AR, Ribeiro NP, Silva AC, Hallak JE, Crippa JA, Nardi AE, Zuardi AW. Cannabidiol, a Cannabis sativa constituent, as an anxiolytic drug. Braz J Psychiatry. 2012 Jun;34 Suppl 1:S104-10. doi: 10.1590/s1516-44462012000500008. English, Portuguese.

  PMID: 22729452 BACKGROUND

• Nagarkatti P, Pandey R, Rieder SA, Hegde VL, Nagarkatti M. Cannabinoids as novel anti-inflammatory drugs. Future Med Chem. 2009 Oct;1(7):1333-49. doi: 10.4155/fmc.09.93.

  PMID: 20191092 BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Oils; Cannabidiol

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Lipids; Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Neurology, Faculty of Health Sciences, Medical University of Warsaw

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: June 16, 2026
• Study Start: December 18, 2023
• Primary Completion: November 17, 2024
• Study Completion: November 17, 2024
• Last Updated: June 16, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)