Full-Spectrum Cannabidiol Oil for Anxiety and Depressive Symptoms in Parkinson's Disease (COOPERATE)
2026年6月10日 更新者：Stanislaw Szlufik、Medical University of Warsaw
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.
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.
調査の概要
研究の種類
介入
入学 (実際)
27
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Warsaw、ポーランド
- Department of Neurology, Faculty of Health Sciences, Medical University of Warsaw
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：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
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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.
他の名前：
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アクティブコンパレータ：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
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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.
他の名前：
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アクティブコンパレータ：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
|
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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in anxiety symptom severity measured by the Beck Anxiety Inventory (BAI)
時間枠：Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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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.
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Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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Change in depressive symptom severity measured by the Beck Depression Inventory-I (BDI-I)
時間枠：Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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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.
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Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in insomnia severity measured by the Athens Insomnia Scale (AIS)
時間枠：Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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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.
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Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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Change in anxiety symptoms measured by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)
時間枠：Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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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.
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Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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Change in depressive symptoms measured by the Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)
時間枠：Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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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.
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Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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Change in depression symptoms measured by the Depression Anxiety Stress Scales - Depression Subscale (DASS-21 Depression)
時間枠：Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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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.
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Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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Change in anxiety symptoms measured by the Depression Anxiety Stress Scales - Anxiety Subscale (DASS-21 Anxiety)
時間枠：Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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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.
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Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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Change in stress symptoms measured by the Depression Anxiety Stress Scales - Stress Subscale (DASS-21 Stress)
時間枠：Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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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.
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Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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Change in psychosis symptom severity measured by the Parkinson Psychosis Questionnaire (PPQ)
時間枠：Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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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.
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Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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Change in life satisfaction measured by the Satisfaction With Life Scale (SWLS)
時間枠：Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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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.
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Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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Change in fatigue measured by the Fatigue Assessment Scale (FAS)
時間枠：Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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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.
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Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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Change in pain severity measured by the Visual Analogue Scale (VAS)
時間枠：Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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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.
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Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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Change in health-related quality of life measured by the Parkinson's Disease Questionnaire (PDQ-39)
時間枠：Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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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.
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Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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Change in sleep-related symptoms measured by the Parkinson's Disease Sleep Scale (PDSS-1)
時間枠：Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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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.
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Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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Change in motor symptom severity measured by the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
時間枠：Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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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.
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Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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Change in non-motor symptom burden measured by the Non-Motor Symptoms Scale (NMSS)
時間枠：Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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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.
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Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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Change in daytime sleepiness measured by the Epworth Sleepiness Scale (ESS)
時間枠：Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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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.
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Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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Change in health-related quality of life measured by the EuroQol-5D (EQ-5D)
時間枠：Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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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.
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Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in motor activity parameters measured by wearable gyroscopic-magnetometric sensors
時間枠：Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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Motor function will be assessed using wearable gyroscopic-magnetometric sensors during clinic-based and home-based assessments.
The outcome measure is the change in sensor-derived motor function parameters from baseline to subsequent assessment time points.
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Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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Participant-rated perceived treatment effectiveness
時間枠：Month 1 and Month 2 (end of treatment)
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Participants will provide a subjective rating of the perceived effectiveness of the study intervention during treatment visits.
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Month 1 and Month 2 (end of treatment)
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Incidence of treatment-emergent adverse events
時間枠：Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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Treatment-emergent adverse events were monitored throughout treatment and follow-up.
The outcome measure is the incidence of adverse events occurring after initiation of cannabidiol treatment.
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Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2023年12月18日
一次修了 (実際)
2024年11月17日
研究の完了 (実際)
2024年11月17日
試験登録日
最初に提出
2025年7月7日
QC基準を満たした最初の提出物
2026年6月10日
最初の投稿 (実際)
2026年6月16日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月16日
QC基準を満たした最後の更新が送信されました
2026年6月10日
最終確認日
2025年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。