Full-Spectrum Cannabidiol Oil for Anxiety and Depressive Symptoms in Parkinson's Disease (COOPERATE)
10 de junio de 2026 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
27
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Warsaw, Polonia
- Department of Neurology, Faculty of Health Sciences, Medical University of Warsaw
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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
|
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.
Otros nombres:
|
|
Comparador activo: 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.
Otros nombres:
|
|
Comparador activo: 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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in anxiety symptom severity measured by the Beck Anxiety Inventory (BAI)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in insomnia severity measured by the Athens Insomnia Scale (AIS)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in motor activity parameters measured by wearable gyroscopic-magnetometric sensors
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
18 de diciembre de 2023
Finalización primaria (Actual)
17 de noviembre de 2024
Finalización del estudio (Actual)
17 de noviembre de 2024
Fechas de registro del estudio
Enviado por primera vez
7 de julio de 2025
Primero enviado que cumplió con los criterios de control de calidad
10 de junio de 2026
Publicado por primera vez (Actual)
16 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de junio de 2026
Última verificación
1 de julio de 2025
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KB/279/2023
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .