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Auteur Dorit SHMUELI |
Documents disponibles écrits par cet auteur (2)
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Cannabinoid treatment for autism: a proof-of-concept randomized trial / Adi ARAN in Molecular Autism, 12 (2021)
[article]
Titre : Cannabinoid treatment for autism: a proof-of-concept randomized trial Type de document : Texte imprimé et/ou numérique Auteurs : Adi ARAN, Auteur ; Moria HAREL, Auteur ; Hanoch CASSUTO, Auteur ; Lola POLYANSKY, Auteur ; Aviad SCHNAPP, Auteur ; Nadia WATTAD, Auteur ; Dorit SHMUELI, Auteur ; Daphna GOLAN, Auteur ; Francisco Xavier CASTELLANOS, Auteur Article en page(s) : 6p. Langues : Anglais (eng) Mots-clés : Autism spectrum disorder Behavior Cannabidiol Cannabinoids Child psychiatry Clinical trials randomized controlled Developmental disorders Entourage effect Neuropsychology Tetrahydrocannabinol Index. décimale : PER Périodiques Résumé : BACKGROUND: Endocannabinoid dysfunction in animal models of autism spectrum disorder (ASD) and accumulating, albeit anecdotal, evidence for efficacy in humans motivated this placebo-controlled double-blind comparison of two oral cannabinoid solutions in 150 participants (age 5-21 years) with ASD. METHODS: We tested (1) BOL-DP-O-01-W, a whole-plant cannabis extract containing cannabidiol and ?9-tetrahydrocannabinol at a 20:1 ratio and (2) BOL-DP-O-01, purified cannabidiol and ?9-tetrahydrocannabinol at the same ratio. Participants (N?=?150) received either placebo or cannabinoids for 12-weeks (testing efficacy) followed by a 4-week washout and predetermined cross-over for another 12 weeks to further assess tolerability. Registered primary efficacy outcome measures were improvement in behavioral problems (differences between whole-plant extract and placebo) on the Home Situation Questionnaire-ASD (HSQ-ASD) and the Clinical Global Impression-Improvement scale with disruptive behavior anchor points (CGI-I). Secondary measures were Social Responsiveness Scale (SRS-2) and Autism Parenting Stress Index (APSI). RESULTS: Changes in Total Scores of HSQ-ASD (primary-outcome) and APSI (secondary-outcome) did not differ among groups. Disruptive behavior on the CGI-I (co-primary outcome) was either much or very much improved in 49% on whole-plant extract (n?=?45) versus 21% on placebo (n?=?47; p?=?0.005). Median SRS Total Score (secondary-outcome) improved by 14.9 on whole-plant extract (n?=?34) versus 3.6 points after placebo (n?=?36); p?=?0.009). There were no treatment-related serious adverse events. Common adverse events included somnolence and decreased appetite, reported for 28% and 25% on whole-plant extract, respectively (n?=?95); 23% and 21% on pure-cannabinoids (n?=?93), and 8% and 15% on placebo (n?=?94). Limitations Lack of pharmacokinetic data and a wide range of ages and functional levels among participants warrant caution when interpreting the results. CONCLUSIONS: This interventional study provides evidence that BOL-DP-O-01-W and BOL-DP-O-01, administrated for 3 months, are well tolerated. Evidence for efficacy of these interventions are mixed and insufficient. Further testing of cannabinoids in ASD is recommended. Trial registration ClinicalTrials.gov: NCT02956226. Registered 06 November 2016, https://clinicaltrials.gov/ct2/show/NCT02956226. En ligne : http://dx.doi.org/10.1186/s13229-021-00420-2 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=442
in Molecular Autism > 12 (2021) . - 6p.[article] Cannabinoid treatment for autism: a proof-of-concept randomized trial [Texte imprimé et/ou numérique] / Adi ARAN, Auteur ; Moria HAREL, Auteur ; Hanoch CASSUTO, Auteur ; Lola POLYANSKY, Auteur ; Aviad SCHNAPP, Auteur ; Nadia WATTAD, Auteur ; Dorit SHMUELI, Auteur ; Daphna GOLAN, Auteur ; Francisco Xavier CASTELLANOS, Auteur . - 6p.
Langues : Anglais (eng)
in Molecular Autism > 12 (2021) . - 6p.
Mots-clés : Autism spectrum disorder Behavior Cannabidiol Cannabinoids Child psychiatry Clinical trials randomized controlled Developmental disorders Entourage effect Neuropsychology Tetrahydrocannabinol Index. décimale : PER Périodiques Résumé : BACKGROUND: Endocannabinoid dysfunction in animal models of autism spectrum disorder (ASD) and accumulating, albeit anecdotal, evidence for efficacy in humans motivated this placebo-controlled double-blind comparison of two oral cannabinoid solutions in 150 participants (age 5-21 years) with ASD. METHODS: We tested (1) BOL-DP-O-01-W, a whole-plant cannabis extract containing cannabidiol and ?9-tetrahydrocannabinol at a 20:1 ratio and (2) BOL-DP-O-01, purified cannabidiol and ?9-tetrahydrocannabinol at the same ratio. Participants (N?=?150) received either placebo or cannabinoids for 12-weeks (testing efficacy) followed by a 4-week washout and predetermined cross-over for another 12 weeks to further assess tolerability. Registered primary efficacy outcome measures were improvement in behavioral problems (differences between whole-plant extract and placebo) on the Home Situation Questionnaire-ASD (HSQ-ASD) and the Clinical Global Impression-Improvement scale with disruptive behavior anchor points (CGI-I). Secondary measures were Social Responsiveness Scale (SRS-2) and Autism Parenting Stress Index (APSI). RESULTS: Changes in Total Scores of HSQ-ASD (primary-outcome) and APSI (secondary-outcome) did not differ among groups. Disruptive behavior on the CGI-I (co-primary outcome) was either much or very much improved in 49% on whole-plant extract (n?=?45) versus 21% on placebo (n?=?47; p?=?0.005). Median SRS Total Score (secondary-outcome) improved by 14.9 on whole-plant extract (n?=?34) versus 3.6 points after placebo (n?=?36); p?=?0.009). There were no treatment-related serious adverse events. Common adverse events included somnolence and decreased appetite, reported for 28% and 25% on whole-plant extract, respectively (n?=?95); 23% and 21% on pure-cannabinoids (n?=?93), and 8% and 15% on placebo (n?=?94). Limitations Lack of pharmacokinetic data and a wide range of ages and functional levels among participants warrant caution when interpreting the results. CONCLUSIONS: This interventional study provides evidence that BOL-DP-O-01-W and BOL-DP-O-01, administrated for 3 months, are well tolerated. Evidence for efficacy of these interventions are mixed and insufficient. Further testing of cannabinoids in ASD is recommended. Trial registration ClinicalTrials.gov: NCT02956226. Registered 06 November 2016, https://clinicaltrials.gov/ct2/show/NCT02956226. En ligne : http://dx.doi.org/10.1186/s13229-021-00420-2 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=442 Large increase in ASD prevalence in Israel between 2017 and 2021 / Ilan DINSTEIN in Autism Research, 17-2 (February 2024)
[article]
Titre : Large increase in ASD prevalence in Israel between 2017 and 2021 Type de document : Texte imprimé et/ou numérique Auteurs : Ilan DINSTEIN, Auteur ; Shirley SOLOMON, Auteur ; Michael ZATS, Auteur ; Ronit SHUSEL, Auteur ; Raphael LOTTNER, Auteur ; Bella Ben GERSHON, Auteur ; Gal MEIRI, Auteur ; Idan MENASHE, Auteur ; Dorit SHMUELI, Auteur Article en page(s) : p.410-418 Langues : Anglais (eng) Index. décimale : PER Périodiques Résumé : Abstract Accurate estimation of annual changes in autism spectrum disorders (ASD) prevalence is critical for planning the expansion of diagnostic, education, and intervention services at an adequate rate. Previous studies from Israel have reported that ASD prevalence among 8-year-old children has increased from estimates of 0.3% in 2008 to 0.65% in 2015 and 1.3% in 2018. Here, we analyzed data acquired from the National Insurance Institute of Israeli (NII), a governmental organization that approves and monitors all ASD children who receive welfare services in Israel, and Clalit Health Services (CHS), the largest Health Maintenance Organization in Israel that provides health services to ~52% of the population. Data from both sources included annual data files from 2017 to 2021 containing the number of ASD cases per year of birth for 1-17-year-old children. This allowed us to estimate annual ASD prevalence among 3.5?million children born between 2000 and 2020 in Israel. Both data sources revealed a nearly two-fold increase in ASD prevalence among 1-17-year-old children from 2017 to 2021. Estimated prevalence rates differed across age groups with 2-3-year-old (day-care) children increasing from 0.27% to 1.19% (>4 fold change), 4-6-year-old (pre-school) children increasing from 0.8% to 1.83%, and 8-year-old children increasing from 0.82% to 1.56% in NII data. These results demonstrate that autism prevalence continues to increase in Israel with a shift towards diagnosis at earlier ages. These findings highlight the challenge facing health and education service providers in meeting the needs of a rapidly growing autism population. En ligne : https://doi.org/10.1002/aur.3085 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=522
in Autism Research > 17-2 (February 2024) . - p.410-418[article] Large increase in ASD prevalence in Israel between 2017 and 2021 [Texte imprimé et/ou numérique] / Ilan DINSTEIN, Auteur ; Shirley SOLOMON, Auteur ; Michael ZATS, Auteur ; Ronit SHUSEL, Auteur ; Raphael LOTTNER, Auteur ; Bella Ben GERSHON, Auteur ; Gal MEIRI, Auteur ; Idan MENASHE, Auteur ; Dorit SHMUELI, Auteur . - p.410-418.
Langues : Anglais (eng)
in Autism Research > 17-2 (February 2024) . - p.410-418
Index. décimale : PER Périodiques Résumé : Abstract Accurate estimation of annual changes in autism spectrum disorders (ASD) prevalence is critical for planning the expansion of diagnostic, education, and intervention services at an adequate rate. Previous studies from Israel have reported that ASD prevalence among 8-year-old children has increased from estimates of 0.3% in 2008 to 0.65% in 2015 and 1.3% in 2018. Here, we analyzed data acquired from the National Insurance Institute of Israeli (NII), a governmental organization that approves and monitors all ASD children who receive welfare services in Israel, and Clalit Health Services (CHS), the largest Health Maintenance Organization in Israel that provides health services to ~52% of the population. Data from both sources included annual data files from 2017 to 2021 containing the number of ASD cases per year of birth for 1-17-year-old children. This allowed us to estimate annual ASD prevalence among 3.5?million children born between 2000 and 2020 in Israel. Both data sources revealed a nearly two-fold increase in ASD prevalence among 1-17-year-old children from 2017 to 2021. Estimated prevalence rates differed across age groups with 2-3-year-old (day-care) children increasing from 0.27% to 1.19% (>4 fold change), 4-6-year-old (pre-school) children increasing from 0.8% to 1.83%, and 8-year-old children increasing from 0.82% to 1.56% in NII data. These results demonstrate that autism prevalence continues to increase in Israel with a shift towards diagnosis at earlier ages. These findings highlight the challenge facing health and education service providers in meeting the needs of a rapidly growing autism population. En ligne : https://doi.org/10.1002/aur.3085 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=522