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

10 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

27

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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
Integratore alimentare: 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.
Altri nomi:
  • Olio di CBD
  • Cannabidiol oil
Comparatore attivo: 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
Integratore alimentare: 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.
Altri nomi:
  • Olio di CBD
  • Cannabidiol oil
Comparatore attivo: 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
Integratore alimentare: 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.
Altri nomi:
  • Olio di CBD
  • Cannabidiol oil

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in anxiety symptom severity measured by the Beck Anxiety Inventory (BAI)
Lasso di tempo: 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)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in insomnia severity measured by the Athens Insomnia Scale (AIS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in motor activity parameters measured by wearable gyroscopic-magnetometric sensors
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Medical University of Warsaw

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

18 dicembre 2023

Completamento primario (Effettivo)

17 novembre 2024

Completamento dello studio (Effettivo)

17 novembre 2024

Date di iscrizione allo studio

Primo inviato

7 luglio 2025

Primo inviato che soddisfa i criteri di controllo qualità

10 giugno 2026

Primo Inserito (Effettivo)

16 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 giugno 2026

Ultimo verificato

1 luglio 2025

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KB/279/2023

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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