Full-Spectrum Cannabidiol Oil for Anxiety and Depressive Symptoms in Parkinson's Disease (COOPERATE)
10 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
27
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Warsaw, Polônia
- Department of Neurology, Faculty of Health Sciences, Medical University of Warsaw
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: 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.
Outros nomes:
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Comparador Ativo: 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
|
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.
Outros nomes:
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Comparador Ativo: 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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in anxiety symptom severity measured by the Beck Anxiety Inventory (BAI)
Prazo: 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)
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in insomnia severity measured by the Athens Insomnia Scale (AIS)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in motor activity parameters measured by wearable gyroscopic-magnetometric sensors
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
18 de dezembro de 2023
Conclusão Primária (Real)
17 de novembro de 2024
Conclusão do estudo (Real)
17 de novembro de 2024
Datas de inscrição no estudo
Enviado pela primeira vez
7 de julho de 2025
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de junho de 2026
Primeira postagem (Real)
16 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de junho de 2026
Última verificação
1 de julho de 2025
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KB/279/2023
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .