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

2026년 6월 10일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

27

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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
건강 보조 식품: Full-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.
다른 이름들:
  • CBD 오일
  • Cannabidiol oil
활성 비교기: 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
건강 보조 식품: Full-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.
다른 이름들:
  • CBD 오일
  • Cannabidiol oil
활성 비교기: 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
건강 보조 식품: Full-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.
다른 이름들:
  • CBD 오일
  • Cannabidiol oil

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in anxiety symptom severity measured by the Beck Anxiety Inventory (BAI)
기간: 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.
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)
기간: 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.
Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)

2차 결과 측정

결과 측정
측정값 설명
기간
Change in insomnia severity measured by the Athens Insomnia Scale (AIS)
기간: 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.
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)
기간: 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.
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)
기간: 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.
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)
기간: 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.
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)
기간: 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.
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)
기간: 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.
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)
기간: 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.
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)
기간: 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.
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)
기간: 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.
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)
기간: 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.
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)
기간: 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.
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)
기간: 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.
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)
기간: 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.
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)
기간: 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.
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)
기간: 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.
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)
기간: 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.
Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)

기타 결과 측정

결과 측정
측정값 설명
기간
Change in motor activity parameters measured by wearable gyroscopic-magnetometric sensors
기간: Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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.
Baseline, Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
Participant-rated perceived treatment effectiveness
기간: Month 1 and Month 2 (end of treatment)
Participants will provide a subjective rating of the perceived effectiveness of the study intervention during treatment visits.
Month 1 and Month 2 (end of treatment)
Incidence of treatment-emergent adverse events
기간: Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)
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.
Month 1, Month 2 (end of treatment), and Month 3 (1-month post-treatment follow-up)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Medical University of Warsaw

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 12월 18일

기본 완료 (실제)

2024년 11월 17일

연구 완료 (실제)

2024년 11월 17일

연구 등록 날짜

최초 제출

2025년 7월 7일

QC 기준을 충족하는 최초 제출

2026년 6월 10일

처음 게시됨 (실제)

2026년 6월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 10일

마지막으로 확인됨

2025년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • KB/279/2023

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

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아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

파킨슨병(PD)에 대한 임상 시험

Full-spectrum Cannabidiol (CBD) oil에 대한 임상 시험

유사한 임상시험 검색

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약물 개입

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스폰서 / 협력자

위치

구독하다