A pilot randomised placebo‐controlled trial of cannabidiol to reduce severe behavioural problems in children and adolescents with intellectual disability

Efron, Daryl; Freeman, Jeremy L.; Cranswick, Noel; Payne, Jonathan M.; Mulraney, Melissa; Prakash, Chidambaram; Lee, Katherine J.; Taylor, Keith F.; Williams, Katrina

doi:10.1111/bcp.14399

Cited by 24 publications

(24 citation statements)

References 43 publications

(69 reference statements)

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“…Placebo Dravet syndrome 2-week titration period followed by a 12-week maintenance period GW Pharmaceuticals Fairhurst et al 51 RCT, double-blind 72 8.0–18.0 Spray max 12 actuations of Nabiximols spray c vs. Placebo Spasticity due to cerebral palsy or traumatic, non‐progressive CNS injury Patients titrated over a period of 9 weeks followed by 3 weeks of maintenance to a total of 12 weeks GW Pharmaceuticals Efron et al 52 RCT, double-blind 8 8.0–16.0 Oral solution CBD 20 mg/kg/d vs. Placebo Severe behavioral problems with intellectual disability 9-days up-titration, followed by 8 weeks of maintenance and 9 days down-titration Internal grant (not commercial sponsor) Aran et al 53 RCT, double-blind, crossover 150 5–21 Oral solution whole-plant cannabis extract, purified CBD and THC vs.…”

Section: Resultsmentioning

confidence: 99%

Efficacy and safety of medical cannabinoids in children: a systematic review and meta-analysis

Treves

Mor

Allegaert

et al. 2021

Sci Rep

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Despite the increased use of medical cannabinoids, the efficacy and safety of the treatment among children remain uncertain. The objective was to study the efficacy and safety of medical cannabinoids in children. The search included studies through 11-May-2020. Selection criteria included studies evaluating efficacy and safety outcomes of medical cannabinoids (tetrahydrocannabinol, cannabidiol and other cannabis derivatives) versus control in children, independently assessed by two reviewers. Eight studies were included, all of which are randomized controlled trials. Cannabidiol is associated with 50% reduction in seizures rate (Relative Risk (RR) = 1.69, 95% CI [1.20–2.36]) and caregiver global impression of change (Median Estimated difference = (− 1), 95%CI [− 1.39–(− 0.60)]) in Dravet syndrome, compared to placebo. While cannabidiol was associated with a reduction in reported seizure events (RR = 0.59, 95% CI [0.36–0.97]), no association was found in products contained also tetrahydrocannabinol (RR = 1.35, 95% CI [0.46–4.03]). Higher dose of cannabidiol was associated with decreased appetite (RR = 2.40, 95% CI [1.39–4.15]). A qualitative assessment suggests that medical cannabinoids might be associated with adverse mental events. In conclusion, cannabidiol is associated with clinical improvement in Dravet syndrome. However, cannabidiol is also associated with decreased appetite. Adverse mental events were reported as well, however, more research should be performed to assess well this outcome.

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Section: Resultsmentioning

confidence: 99%

Efficacy and safety of medical cannabinoids in children: a systematic review and meta-analysis

Treves

Mor

Allegaert

et al. 2021

Sci Rep

View full text Add to dashboard Cite

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“…( Almog, et al, 2020 ; Birnbaum, et al, 2019 ; Efron, et al, 2021 ; Freeman, et al, 2020 ; Grimison, et al, 2020 ; Hotz, et al, 2021 ; Hurd, et al, 2019 ; Izgelov, et al, 2020 ; Lintzeris, et al, 2020 ; Mitelpunkt, et al, 2019 ; O'Neill, et al, 2021 ; Perkins, et al, 2020 ; Pretzsch, et al, 2019a ; Pretzsch, et al, 2019c ; Wall, et al, 2019 ; Xu, et al, 2020 ; Yassin, et al, 2019 ; Zylla, et al, 2021 )…”

Section: Resultsunclassified

Cannabis for Medical Use: Analysis of Recent Clinical Trials in View of Current Legislation

et al. 2022

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Cannabis has long been regarded as a recreational substance in the Western world. The recent marketing authorization of some medicinal products of industrial origin and the introduction onto the market of inflorescences for medical use mean that medical doctors can now prescribe Cannabis-based medicines in those countries which allow it. Nevertheless, there is still considerable controversy on this topic in the scientific community. In particular, this controversy concerns: the plant species to be used; the pathologies that can be treated and consequently the efficacy and safety of use; the routes of administration; the methods of preparation; the type and dosage of cannabinoids to be used; and, the active molecules of interest. As such, although medical Cannabis has been historically used, the results of currently completed and internationally published studies are inconclusive and often discordant. In light of these considerations, the aim of this work is to analyse the current legislation in countries that allow the use of medical Cannabis, in relation to the impact that this legislation has had on clinical trials. First of all, a literature search has been performed (PubMed and SciFinder) on clinical trials which involved the administration of Cannabis for medical use over the last 3 years. Of the numerous studies extrapolated from the literature, only about 43 reported data on clinical trials on medical Cannabis, with these mainly being performed in Australia, Brazil, Canada, Denmark, Germany, Israel, Netherlands, Switzerland, the United Kingdom and the United States of America. Once the reference countries were identified, an evaluation of the legislation in relation to Cannabis for medical use in each was carried out via the consultation of the pertinent scientific literature, but also of official government documentation and that of local regulatory authorities. This analysis provided us with an overview of the different legislation in these countries and, consequently, allowed us to analyse, with greater awareness, the results of the clinical trials published in the last 3 years in order to obtain general interest indications in the prosecution of scientific research in this area.

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“…However, it is not known whether ID is associated with alterations in the ECS. There is growing interest from parents of children with ID to determine whether CBP can reduce behaviour problems in children and adolescents with ID [49,50].…”

Section: Rationalementioning

confidence: 99%

Efficacy of cannabinoids in neurodevelopmental and neuropsychiatric disorders among children and adolescents: a systematic review

Rice

Cannon

Dadlani

et al. 2023

Eur Child Adolesc Psychiatry

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A better understanding of the endocannabinoid system and a relaxation in regulatory control of cannabis globally has increased interest in the medicinal use of cannabinoid-based products (CBP). We provide a systematic review of the rationale and current clinical trial evidence for CBP in the treatment of neuropsychiatric and neurodevelopmental disorders in children and adolescents. A systematic search of MEDLINE, Embase, PsycINFO, and the Cochrane Central Register of Trials was performed to identify articles published after 1980 about CBP for medical purposes in individuals aged 18 years or younger with selected neuropsychiatric or neurodevelopmental conditions. Risk of bias and quality of evidence was assessed for each article. Of 4466 articles screened, 18 were eligible for inclusion, addressing eight conditions (anxiety disorders (n = 1); autism spectrum disorder (n = 5); foetal alcohol spectrum disorder (n = 1); fragile X syndrome (n = 2); intellectual disability (n = 1); mood disorders (n = 2); post-traumatic stress disorder (n = 3); and Tourette syndrome (n = 3)). Only one randomised controlled trial (RCT) was identified. The remaining seventeen articles included one open-label trial, three uncontrolled before-and-after trials, two case series and 11 case reports, thus the risk of bias was high. Despite growing community and scientific interest, our systematic review identified limited and generally poor-quality evidence for the efficacy of CBP in neuropsychiatric and neurodevelopmental disorders in children and adolescents. Large rigorous RCTs are required to inform clinical care. In the meantime, clinicians must balance patient expectations with the limited evidence available.

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A pilot randomised placebo‐controlled trial of cannabidiol to reduce severe behavioural problems in children and adolescents with intellectual disability

Cited by 24 publications

References 43 publications

Efficacy and safety of medical cannabinoids in children: a systematic review and meta-analysis

Efficacy and safety of medical cannabinoids in children: a systematic review and meta-analysis

Cannabis for Medical Use: Analysis of Recent Clinical Trials in View of Current Legislation

Efficacy of cannabinoids in neurodevelopmental and neuropsychiatric disorders among children and adolescents: a systematic review

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