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

10. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

27

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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
Doplněk stravy: 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.
Ostatní jména:
  • CBD olej
  • Cannabidiol oil
Aktivní komparátor: 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
Doplněk stravy: 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.
Ostatní jména:
  • CBD olej
  • Cannabidiol oil
Aktivní komparátor: 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
Doplněk stravy: 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.
Ostatní jména:
  • CBD olej
  • Cannabidiol oil

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in anxiety symptom severity measured by the Beck Anxiety Inventory (BAI)
Časové okno: 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)
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in insomnia severity measured by the Athens Insomnia Scale (AIS)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in motor activity parameters measured by wearable gyroscopic-magnetometric sensors
Časové okno: 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
Časové okno: 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
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Medical University of Warsaw

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

18. prosince 2023

Primární dokončení (Aktuální)

17. listopadu 2024

Dokončení studie (Aktuální)

17. listopadu 2024

Termíny zápisu do studia

První předloženo

7. července 2025

První předloženo, které splnilo kritéria kontroly kvality

10. června 2026

První zveřejněno (Aktuální)

16. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

16. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. června 2026

Naposledy ověřeno

1. července 2025

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • KB/279/2023

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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