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Brief Report: Cannabidiol-Rich Cannabis in Children with Autism Spectrum Disorder and Severe Behavioral Problems-A Retrospective Feasibility Study / Adi ARAN in Journal of Autism and Developmental Disorders, 49-3 (March 2019)
[article]
Titre : Brief Report: Cannabidiol-Rich Cannabis in Children with Autism Spectrum Disorder and Severe Behavioral Problems-A Retrospective Feasibility Study Type de document : Texte imprimé et/ou numérique Auteurs : Adi ARAN, Auteur ; Hanoch CASSUTO, Auteur ; A. LUBOTZKY, Auteur ; N. WATTAD, Auteur ; E. HAZAN, Auteur Article en page(s) : p.1284-1288 Langues : Anglais (eng) Mots-clés : Autism spectrum disorder Cannabidiol Disruptive behavior Medical cannabis Medical marijuana Index. décimale : PER Périodiques Résumé : Anecdotal evidence of successful cannabis treatment in autism spectrum disorder (ASD) are accumulating but clinical studies are lacking. This retrospective study assessed tolerability and efficacy of cannabidiol-rich cannabis, in 60 children with ASD and severe behavioral problems (age = 11.8 +/- 3.5, range 5.0-17.5; 77% low functioning; 83% boys). Efficacy was assessed using the Caregiver Global Impression of Change scale. Adverse events included sleep disturbances (14%) irritability (9%) and loss of appetite (9%). One girl who used higher tetrahydrocannabinol had a transient serious psychotic event which required treatment with an antipsychotic. Following the cannabis treatment, behavioral outbreaks were much improved or very much improved in 61% of patients. This preliminary study supports feasibility of CBD-based cannabis trials in children with ASD. En ligne : http://dx.doi.org/10.1007/s10803-018-3808-2 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=386
in Journal of Autism and Developmental Disorders > 49-3 (March 2019) . - p.1284-1288[article] Brief Report: Cannabidiol-Rich Cannabis in Children with Autism Spectrum Disorder and Severe Behavioral Problems-A Retrospective Feasibility Study [Texte imprimé et/ou numérique] / Adi ARAN, Auteur ; Hanoch CASSUTO, Auteur ; A. LUBOTZKY, Auteur ; N. WATTAD, Auteur ; E. HAZAN, Auteur . - p.1284-1288.
Langues : Anglais (eng)
in Journal of Autism and Developmental Disorders > 49-3 (March 2019) . - p.1284-1288
Mots-clés : Autism spectrum disorder Cannabidiol Disruptive behavior Medical cannabis Medical marijuana Index. décimale : PER Périodiques Résumé : Anecdotal evidence of successful cannabis treatment in autism spectrum disorder (ASD) are accumulating but clinical studies are lacking. This retrospective study assessed tolerability and efficacy of cannabidiol-rich cannabis, in 60 children with ASD and severe behavioral problems (age = 11.8 +/- 3.5, range 5.0-17.5; 77% low functioning; 83% boys). Efficacy was assessed using the Caregiver Global Impression of Change scale. Adverse events included sleep disturbances (14%) irritability (9%) and loss of appetite (9%). One girl who used higher tetrahydrocannabinol had a transient serious psychotic event which required treatment with an antipsychotic. Following the cannabis treatment, behavioral outbreaks were much improved or very much improved in 61% of patients. This preliminary study supports feasibility of CBD-based cannabis trials in children with ASD. En ligne : http://dx.doi.org/10.1007/s10803-018-3808-2 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=386 A phase 1/2, open-label assessment of the safety, tolerability, and efficacy of transdermal cannabidiol (ZYN002) for the treatment of pediatric fragile X syndrome / H. HEUSSLER in Journal of Neurodevelopmental Disorders, 11-1 (December 2019)
[article]
Titre : A phase 1/2, open-label assessment of the safety, tolerability, and efficacy of transdermal cannabidiol (ZYN002) for the treatment of pediatric fragile X syndrome Type de document : Texte imprimé et/ou numérique Auteurs : H. HEUSSLER, Auteur ; J. COHEN, Auteur ; N. SILOVE, Auteur ; N. TICH, Auteur ; M. O. BONN-MILLER, Auteur ; W. DU, Auteur ; C. O'NEILL, Auteur ; T. SEBREE, Auteur Article en page(s) : 16 p. Langues : Anglais (eng) Mots-clés : Cannabidiol Fragile X Pediatric Transdermal Zyn002 Zynerba Index. décimale : PER Périodiques Résumé : BACKGROUND: Fragile X syndrome (FXS) is characterized by a range of developmental, neuropsychiatric, and behavioral symptoms that cause significant impairment in those with the disorder. Cannabidiol (CBD) holds promise as a potential treatment for FXS symptoms due to its safety profile and positive effects on a number of emotional and behavioral symptoms associated with FXS. The aim of the current study was to evaluate the safety, tolerability, and initial efficacy of ZYN002, a transdermal CBD gel, in a pediatric population with FXS. METHODS: Twenty children and adolescents (aged 6-17 years) with a diagnosis of FXS (confirmed through molecular documentation of FMR1 full mutation) were enrolled in an open-label, multi-site, trial of ZYN002. Transdermal CBD gel was administered twice daily for 12 weeks, titrated from 50 mg to a maximum daily dose of 250 mg. The primary efficacy endpoint was change from screening to week 12 on the Anxiety, Depression, and Mood Scale (ADAMS). Secondary endpoint measures included the Aberrant Behavior Checklist-Community for FXS (ABC-CFXS), Pediatric Anxiety Rating Scale (PARS-R), Pediatric Quality of Life Inventory (PedsQL), three Visual Analogue Scales (VAS), and the Clinical Global Impression Scale-Severity (CGI-S) and Improvement (CGI-I). RESULTS: The majority of treatment-emergent AEs (reported by 85% of participants) were mild in severity (70%), and no serious adverse events were reported. There was a statistically significant reduction in ADAMS total score from screening to week 12 and significant reductions on nearly all other secondary endpoints, including all ADAMS subscales (except depressed mood), all ABC-CFXS subscale scores (e.g., social avoidance, irritability), PARS-R total severity score, and PedsQL total score. CONCLUSIONS: ZYN002 was well tolerated and produced clinically meaningful reductions in anxiety and behavioral symptoms in children and adolescents with FXS. These findings support further study of ZYN002 in a randomized, well-controlled trial for the treatment of behavioral symptoms of FXS. TRIAL REGISTRATION: ANZCTR, ACTRN12617000150347 Registered 27 January 2017. En ligne : https://dx.doi.org/10.1186/s11689-019-9277-x Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=409
in Journal of Neurodevelopmental Disorders > 11-1 (December 2019) . - 16 p.[article] A phase 1/2, open-label assessment of the safety, tolerability, and efficacy of transdermal cannabidiol (ZYN002) for the treatment of pediatric fragile X syndrome [Texte imprimé et/ou numérique] / H. HEUSSLER, Auteur ; J. COHEN, Auteur ; N. SILOVE, Auteur ; N. TICH, Auteur ; M. O. BONN-MILLER, Auteur ; W. DU, Auteur ; C. O'NEILL, Auteur ; T. SEBREE, Auteur . - 16 p.
Langues : Anglais (eng)
in Journal of Neurodevelopmental Disorders > 11-1 (December 2019) . - 16 p.
Mots-clés : Cannabidiol Fragile X Pediatric Transdermal Zyn002 Zynerba Index. décimale : PER Périodiques Résumé : BACKGROUND: Fragile X syndrome (FXS) is characterized by a range of developmental, neuropsychiatric, and behavioral symptoms that cause significant impairment in those with the disorder. Cannabidiol (CBD) holds promise as a potential treatment for FXS symptoms due to its safety profile and positive effects on a number of emotional and behavioral symptoms associated with FXS. The aim of the current study was to evaluate the safety, tolerability, and initial efficacy of ZYN002, a transdermal CBD gel, in a pediatric population with FXS. METHODS: Twenty children and adolescents (aged 6-17 years) with a diagnosis of FXS (confirmed through molecular documentation of FMR1 full mutation) were enrolled in an open-label, multi-site, trial of ZYN002. Transdermal CBD gel was administered twice daily for 12 weeks, titrated from 50 mg to a maximum daily dose of 250 mg. The primary efficacy endpoint was change from screening to week 12 on the Anxiety, Depression, and Mood Scale (ADAMS). Secondary endpoint measures included the Aberrant Behavior Checklist-Community for FXS (ABC-CFXS), Pediatric Anxiety Rating Scale (PARS-R), Pediatric Quality of Life Inventory (PedsQL), three Visual Analogue Scales (VAS), and the Clinical Global Impression Scale-Severity (CGI-S) and Improvement (CGI-I). RESULTS: The majority of treatment-emergent AEs (reported by 85% of participants) were mild in severity (70%), and no serious adverse events were reported. There was a statistically significant reduction in ADAMS total score from screening to week 12 and significant reductions on nearly all other secondary endpoints, including all ADAMS subscales (except depressed mood), all ABC-CFXS subscale scores (e.g., social avoidance, irritability), PARS-R total severity score, and PedsQL total score. CONCLUSIONS: ZYN002 was well tolerated and produced clinically meaningful reductions in anxiety and behavioral symptoms in children and adolescents with FXS. These findings support further study of ZYN002 in a randomized, well-controlled trial for the treatment of behavioral symptoms of FXS. TRIAL REGISTRATION: ANZCTR, ACTRN12617000150347 Registered 27 January 2017. En ligne : https://dx.doi.org/10.1186/s11689-019-9277-x Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=409 Brief Report: Suspected Cannabis-Induced Mania and Psychosis in Young Adult Males with Autism Spectrum Disorder / Majd AL-SOLEITI in Journal of Autism and Developmental Disorders, 52-9 (September 2022)
[article]
Titre : Brief Report: Suspected Cannabis-Induced Mania and Psychosis in Young Adult Males with Autism Spectrum Disorder Type de document : Texte imprimé et/ou numérique Auteurs : Majd AL-SOLEITI, Auteur ; Kayla BALAJ, Auteur ; Robyn P. THOM, Auteur ; Christopher J. MCDOUGLE, Auteur ; Christopher J. KEARY, Auteur Article en page(s) : p.4164-4171 Langues : Anglais (eng) Mots-clés : Autism Spectrum Disorder/diagnosis/etiology Cannabis Humans Male Mania Psychotic Disorders/etiology Retrospective Studies Young Adult Autism Autism spectrum disorder Cannabidiol Clinical trials Delta-9-tetrahydrocannabinol Index. décimale : PER Périodiques Résumé : There is increasing interest in investigating cannabis for behavioral symptoms in individuals with autism spectrum disorder (ASD). The potential role of dysregulated cannabinoid signaling contributing to the pathophysiology of ASD is an area of active investigation. Results from retrospective and uncontrolled trials of cannabis in subjects with ASD have been published, reporting both potential benefits and adverse effects. Here, we describe the clinical course of three young adult males with ASD who developed mania or psychosis after the consistent use of cannabidiol and delta-9-tetrahydrocannabinol. Caution should be utilized with cannabis use in individuals with ASD until large-scale, replicated randomized controlled trials demonstrating efficacy, safety and tolerability have been published. En ligne : http://dx.doi.org/10.1007/s10803-021-05254-8 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=486
in Journal of Autism and Developmental Disorders > 52-9 (September 2022) . - p.4164-4171[article] Brief Report: Suspected Cannabis-Induced Mania and Psychosis in Young Adult Males with Autism Spectrum Disorder [Texte imprimé et/ou numérique] / Majd AL-SOLEITI, Auteur ; Kayla BALAJ, Auteur ; Robyn P. THOM, Auteur ; Christopher J. MCDOUGLE, Auteur ; Christopher J. KEARY, Auteur . - p.4164-4171.
Langues : Anglais (eng)
in Journal of Autism and Developmental Disorders > 52-9 (September 2022) . - p.4164-4171
Mots-clés : Autism Spectrum Disorder/diagnosis/etiology Cannabis Humans Male Mania Psychotic Disorders/etiology Retrospective Studies Young Adult Autism Autism spectrum disorder Cannabidiol Clinical trials Delta-9-tetrahydrocannabinol Index. décimale : PER Périodiques Résumé : There is increasing interest in investigating cannabis for behavioral symptoms in individuals with autism spectrum disorder (ASD). The potential role of dysregulated cannabinoid signaling contributing to the pathophysiology of ASD is an area of active investigation. Results from retrospective and uncontrolled trials of cannabis in subjects with ASD have been published, reporting both potential benefits and adverse effects. Here, we describe the clinical course of three young adult males with ASD who developed mania or psychosis after the consistent use of cannabidiol and delta-9-tetrahydrocannabinol. Caution should be utilized with cannabis use in individuals with ASD until large-scale, replicated randomized controlled trials demonstrating efficacy, safety and tolerability have been published. En ligne : http://dx.doi.org/10.1007/s10803-021-05254-8 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=486 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