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Decades of Progress in the Psychopharmacology of Autism Spectrum Disorder / E. HENNEBERRY in Journal of Autism and Developmental Disorders, 51-12 (December 2021)
[article]
Titre : Decades of Progress in the Psychopharmacology of Autism Spectrum Disorder Type de document : Texte imprimé et/ou numérique Auteurs : E. HENNEBERRY, Auteur ; M. LAMY, Auteur ; K. C. DOMINICK, Auteur ; C. A. ERICKSON, Auteur Article en page(s) : p.4370-4394 Langues : Anglais (eng) Mots-clés : Antipsychotic Agents/therapeutic use Autism Spectrum Disorder/drug therapy Autistic Disorder/drug therapy Humans Irritable Mood Psychopharmacology Anti-psychotic Autism Autism spectrum disorder Drug treatment Irritability Index. décimale : PER Périodiques Résumé : Recent decades have been marked by a wave drug treatment research in autism spectrum disorder (ASD). This work has resulted in improved ability to treat commonly occurring behavioral challenges associated with ASD including most prominently irritability marked by aggression, self-injurious behavior, and severe tantrums. While treatment of interfering behavior has progressed in our field, there remain several areas of unmet medical need including most prominently a lack of any approved drug therapies for the core, defining symptoms of autism. We outline the progress to date in the field of autism drug treatment while taking a future look forward into how decades of work can inform better future steps in this field. En ligne : http://dx.doi.org/10.1007/s10803-021-05237-9 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=454
in Journal of Autism and Developmental Disorders > 51-12 (December 2021) . - p.4370-4394[article] Decades of Progress in the Psychopharmacology of Autism Spectrum Disorder [Texte imprimé et/ou numérique] / E. HENNEBERRY, Auteur ; M. LAMY, Auteur ; K. C. DOMINICK, Auteur ; C. A. ERICKSON, Auteur . - p.4370-4394.
Langues : Anglais (eng)
in Journal of Autism and Developmental Disorders > 51-12 (December 2021) . - p.4370-4394
Mots-clés : Antipsychotic Agents/therapeutic use Autism Spectrum Disorder/drug therapy Autistic Disorder/drug therapy Humans Irritable Mood Psychopharmacology Anti-psychotic Autism Autism spectrum disorder Drug treatment Irritability Index. décimale : PER Périodiques Résumé : Recent decades have been marked by a wave drug treatment research in autism spectrum disorder (ASD). This work has resulted in improved ability to treat commonly occurring behavioral challenges associated with ASD including most prominently irritability marked by aggression, self-injurious behavior, and severe tantrums. While treatment of interfering behavior has progressed in our field, there remain several areas of unmet medical need including most prominently a lack of any approved drug therapies for the core, defining symptoms of autism. We outline the progress to date in the field of autism drug treatment while taking a future look forward into how decades of work can inform better future steps in this field. En ligne : http://dx.doi.org/10.1007/s10803-021-05237-9 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=454 A randomized placebo-controlled pilot study of N-acetylcysteine in youth with autism spectrum disorder / L. K. WINK in Molecular Autism, 7 (2016)
[article]
Titre : A randomized placebo-controlled pilot study of N-acetylcysteine in youth with autism spectrum disorder Type de document : Texte imprimé et/ou numérique Auteurs : L. K. WINK, Auteur ; R. ADAMS, Auteur ; Z. WANG, Auteur ; J. E. KLAUNIG, Auteur ; M. H. PLAWECKI, Auteur ; D. J. POSEY, Auteur ; C. J. MCDOUGLE, Auteur ; C. A. ERICKSON, Auteur Article en page(s) : 26p. Langues : Anglais (eng) Mots-clés : Acetylcysteine/pharmacology/therapeutic use Administration, Oral Autism Spectrum Disorder/drug therapy Child Child, Preschool Comet Assay DNA Damage/drug effects Double-Blind Method Drug Administration Schedule Female Follow-Up Studies Free Radical Scavengers/pharmacology/therapeutic use Glutathione/blood Homocysteine/blood Humans Male Oxidation-Reduction Oxidative Stress/drug effects Pilot Projects Placebo Effect Social Behavior Autism Autism spectrum disorder N-acetylcysteine Oxidative stress Social impairment Index. décimale : PER Périodiques Résumé : BACKGROUND: Social impairment is a defining feature of autism spectrum disorder (ASD) with no demonstrated effective pharmacologic treatments. The goal of this study was to evaluate efficacy, safety, and tolerability of oral N-acetylcysteine (NAC), an antioxidant whose function overlaps with proposed mechanisms of ASD pathophysiology, targeting core social impairment in youth with ASD. METHODS: This study was a 12-week randomized, double-blind, placebo-controlled trial of oral NAC in youth with ASD. Study participants were medically healthy youth age 4 to 12 years with ASD, weighing >/=15 kg, and judged to be moderately ill based on the Clinical Global Impressions Severity scale. The participants were randomized via computer to active drug or placebo in a 1:1 ratio, with the target dose of NAC being 60 mg/kg/day in three divided doses. The primary outcome measure of efficacy was the Clinical Global Impressions Improvement (CGI-I) scale anchored to core social impairment. To investigate the impact of NAC on oxidative stress markers in peripheral blood, venous blood samples were collected at screen and week 12. RESULTS: Thirty-one patients were enrolled (NAC = 16, placebo = 15). Three participants were lost to follow-up, and three left the trial due to adverse effects. The average daily dose of NAC at week 12 was 56.2 mg/kg (SD = 9.7) with dose ranging from 33.6 to 64.3 mg/kg. The frequency of adverse events was so low that comparisons between groups could not be conducted. At week 12, there was no statistically significant difference between the NAC and placebo groups on the CGI-I (p > 0.69) but the glutathione (GSH) level in blood was significantly higher in the NAC group (p < 0.05). The oxidative glutathione disulfide (GSSG) level increased in the NAC group, however only at a trend level of significance (p = 0.09). There was no significant difference between the NAC and placebo groups in the GSH/GSSG ratio, DNA strand break and oxidative damage, and blood homocysteine levels at week 12 (ps > 0.16). CONCLUSIONS: The results of this trial indicate that NAC treatment was well tolerated, had the expected effect of boosting GSH production, but had no significant impact on social impairment in youth with ASD. TRIAL REGISTRATION: Clinicaltrials.gov NCT00453180. En ligne : http://dx.doi.org/10.1186/s13229-016-0088-6 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=329
in Molecular Autism > 7 (2016) . - 26p.[article] A randomized placebo-controlled pilot study of N-acetylcysteine in youth with autism spectrum disorder [Texte imprimé et/ou numérique] / L. K. WINK, Auteur ; R. ADAMS, Auteur ; Z. WANG, Auteur ; J. E. KLAUNIG, Auteur ; M. H. PLAWECKI, Auteur ; D. J. POSEY, Auteur ; C. J. MCDOUGLE, Auteur ; C. A. ERICKSON, Auteur . - 26p.
Langues : Anglais (eng)
in Molecular Autism > 7 (2016) . - 26p.
Mots-clés : Acetylcysteine/pharmacology/therapeutic use Administration, Oral Autism Spectrum Disorder/drug therapy Child Child, Preschool Comet Assay DNA Damage/drug effects Double-Blind Method Drug Administration Schedule Female Follow-Up Studies Free Radical Scavengers/pharmacology/therapeutic use Glutathione/blood Homocysteine/blood Humans Male Oxidation-Reduction Oxidative Stress/drug effects Pilot Projects Placebo Effect Social Behavior Autism Autism spectrum disorder N-acetylcysteine Oxidative stress Social impairment Index. décimale : PER Périodiques Résumé : BACKGROUND: Social impairment is a defining feature of autism spectrum disorder (ASD) with no demonstrated effective pharmacologic treatments. The goal of this study was to evaluate efficacy, safety, and tolerability of oral N-acetylcysteine (NAC), an antioxidant whose function overlaps with proposed mechanisms of ASD pathophysiology, targeting core social impairment in youth with ASD. METHODS: This study was a 12-week randomized, double-blind, placebo-controlled trial of oral NAC in youth with ASD. Study participants were medically healthy youth age 4 to 12 years with ASD, weighing >/=15 kg, and judged to be moderately ill based on the Clinical Global Impressions Severity scale. The participants were randomized via computer to active drug or placebo in a 1:1 ratio, with the target dose of NAC being 60 mg/kg/day in three divided doses. The primary outcome measure of efficacy was the Clinical Global Impressions Improvement (CGI-I) scale anchored to core social impairment. To investigate the impact of NAC on oxidative stress markers in peripheral blood, venous blood samples were collected at screen and week 12. RESULTS: Thirty-one patients were enrolled (NAC = 16, placebo = 15). Three participants were lost to follow-up, and three left the trial due to adverse effects. The average daily dose of NAC at week 12 was 56.2 mg/kg (SD = 9.7) with dose ranging from 33.6 to 64.3 mg/kg. The frequency of adverse events was so low that comparisons between groups could not be conducted. At week 12, there was no statistically significant difference between the NAC and placebo groups on the CGI-I (p > 0.69) but the glutathione (GSH) level in blood was significantly higher in the NAC group (p < 0.05). The oxidative glutathione disulfide (GSSG) level increased in the NAC group, however only at a trend level of significance (p = 0.09). There was no significant difference between the NAC and placebo groups in the GSH/GSSG ratio, DNA strand break and oxidative damage, and blood homocysteine levels at week 12 (ps > 0.16). CONCLUSIONS: The results of this trial indicate that NAC treatment was well tolerated, had the expected effect of boosting GSH production, but had no significant impact on social impairment in youth with ASD. TRIAL REGISTRATION: Clinicaltrials.gov NCT00453180. En ligne : http://dx.doi.org/10.1186/s13229-016-0088-6 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=329 The challenge of detecting adverse events in adults with autism spectrum disorder who have intellectual disability / P. BALLESTER in Autism Research, 15-1 (January 2022)
[article]
Titre : The challenge of detecting adverse events in adults with autism spectrum disorder who have intellectual disability Type de document : Texte imprimé et/ou numérique Auteurs : P. BALLESTER, Auteur ; C. ESPADAS, Auteur ; A. C. LONDOÑO, Auteur ; S. ALMENARA, Auteur ; Víctor AGUILAR, Auteur ; C. BELDA, Auteur ; E. PÉREZ, Auteur ; J. MURIEL, Auteur ; A. M. PEIRO, Auteur Article en page(s) : p.192-202 Langues : Anglais (eng) Mots-clés : Adult Autism Spectrum Disorder/drug therapy Humans Intellectual Disability Male Prospective Studies Psychotropic Drugs/therapeutic use Retrospective Studies adverse events autism spectrum disorder pharmacovigilance Index. décimale : PER Périodiques Résumé : Adults with autism spectrum disorder (ASD) and associated intellectual disability (ID) take a high number of different psychotropic drugs simultaneously. Nowadays, little is known about this multidrug pattern efficacy and safety. The present study has endeavored to fill this gap creating a local pharmacovigilance system. A 36-month, retrospective and prospective, observational, and multicenter pharmacovigilance study was carried out in adults with ASD and ID (n = 83). Information regarding ongoing medications (polypharmacy: taking simultaneously >4 drugs; safety profile: adverse events' number, adverse drug reactions' number, and affected system; and observed-to-expected [O/E] ratio using the summary of product characteristics), and current diagnoses were recorded. A median of four ongoing medications per participant was registered, half of the sample was under polypharmacy regimen. Regarding all ongoing medications, 50% were antipsychotic drugs, and 47% of participants had >1 antipsychotic prescribed. In contrast, only 64 adverse events were identified from electronic health records, mostly due to risperidone. Half of them were related either to nervous or metabolic systems, and almost a third were not previously described in the corresponding drug summary of products characteristics. Extrapyramidalism, gynecomastia, hypercholesterolemia, and urinary retention were some AEs that occurred more frequently than expected (O/E ratio?>?6 times) according to our data. The highest O/E ratio scores (>120 times) were for hypercholesterolemia and rhabdomyolysis caused by valproic acid. According to the number of adverse events and adverse drug reactions reported in electronic health records locally and nationally by clinicians, we need to increase awareness about medications safety. LAY SUMMARY: A 36-month study in adults with autism, ID, and polypharmacy (>4 drugs) was done to investigate drug safety on everyone. A median of four medications per person was registered, half were antipsychotic drugs, and 47% of participants had >1 antipsychotic medication simultaneously. Only 64 adverse events were identified from electronic health records, mostly due to risperidone. Half of them were related to nervous or metabolic systems and a third were not previously described in the drug information sheet. En ligne : http://dx.doi.org/10.1002/aur.2624 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=450
in Autism Research > 15-1 (January 2022) . - p.192-202[article] The challenge of detecting adverse events in adults with autism spectrum disorder who have intellectual disability [Texte imprimé et/ou numérique] / P. BALLESTER, Auteur ; C. ESPADAS, Auteur ; A. C. LONDOÑO, Auteur ; S. ALMENARA, Auteur ; Víctor AGUILAR, Auteur ; C. BELDA, Auteur ; E. PÉREZ, Auteur ; J. MURIEL, Auteur ; A. M. PEIRO, Auteur . - p.192-202.
Langues : Anglais (eng)
in Autism Research > 15-1 (January 2022) . - p.192-202
Mots-clés : Adult Autism Spectrum Disorder/drug therapy Humans Intellectual Disability Male Prospective Studies Psychotropic Drugs/therapeutic use Retrospective Studies adverse events autism spectrum disorder pharmacovigilance Index. décimale : PER Périodiques Résumé : Adults with autism spectrum disorder (ASD) and associated intellectual disability (ID) take a high number of different psychotropic drugs simultaneously. Nowadays, little is known about this multidrug pattern efficacy and safety. The present study has endeavored to fill this gap creating a local pharmacovigilance system. A 36-month, retrospective and prospective, observational, and multicenter pharmacovigilance study was carried out in adults with ASD and ID (n = 83). Information regarding ongoing medications (polypharmacy: taking simultaneously >4 drugs; safety profile: adverse events' number, adverse drug reactions' number, and affected system; and observed-to-expected [O/E] ratio using the summary of product characteristics), and current diagnoses were recorded. A median of four ongoing medications per participant was registered, half of the sample was under polypharmacy regimen. Regarding all ongoing medications, 50% were antipsychotic drugs, and 47% of participants had >1 antipsychotic prescribed. In contrast, only 64 adverse events were identified from electronic health records, mostly due to risperidone. Half of them were related either to nervous or metabolic systems, and almost a third were not previously described in the corresponding drug summary of products characteristics. Extrapyramidalism, gynecomastia, hypercholesterolemia, and urinary retention were some AEs that occurred more frequently than expected (O/E ratio?>?6 times) according to our data. The highest O/E ratio scores (>120 times) were for hypercholesterolemia and rhabdomyolysis caused by valproic acid. According to the number of adverse events and adverse drug reactions reported in electronic health records locally and nationally by clinicians, we need to increase awareness about medications safety. LAY SUMMARY: A 36-month study in adults with autism, ID, and polypharmacy (>4 drugs) was done to investigate drug safety on everyone. A median of four medications per person was registered, half were antipsychotic drugs, and 47% of participants had >1 antipsychotic medication simultaneously. Only 64 adverse events were identified from electronic health records, mostly due to risperidone. Half of them were related to nervous or metabolic systems and a third were not previously described in the drug information sheet. En ligne : http://dx.doi.org/10.1002/aur.2624 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=450 Bumetanide Oral Liquid Formulation for the Treatment of Children and Adolescents with Autism Spectrum Disorder: Design of Two Phase III Studies (SIGN Trials) / V. CRUTEL in Journal of Autism and Developmental Disorders, 51-8 (August 2021)
[article]
Titre : Bumetanide Oral Liquid Formulation for the Treatment of Children and Adolescents with Autism Spectrum Disorder: Design of Two Phase III Studies (SIGN Trials) Type de document : Texte imprimé et/ou numérique Auteurs : V. CRUTEL, Auteur ; E. LAMBERT, Auteur ; P. F. PENELAUD, Auteur ; C. ALBARRÁN SEVERO, Auteur ; J. FUENTES, Auteur ; A. ROSIER, Auteur ; A. HERVAS, Auteur ; S. MARRET, Auteur ; G. OLIVEIRA, Auteur ; Mara PARELLADA, Auteur ; S. KYAGA, Auteur ; S. GOUTTEFANGEAS, Auteur ; M. BERTRAND, Auteur ; D. RAVEL, Auteur ; B. FALISSARD, Auteur Article en page(s) : p.2959-2972 Langues : Anglais (eng) Mots-clés : Adolescent Autism Spectrum Disorder/drug therapy Bumetanide/administration & dosage/therapeutic use Child Child, Preschool Double-Blind Method Humans Male Research Design Social Behavior Treatment Outcome Autism spectrum disorder Bumetanide Pediatrics Randomized controlled trial for Actelion, Allergan, Almirall, Astellas, AstraZeneca, Bayer, Biotronik, BMS, Boehringer Ingelheim, Daiichi- Sankyo, Eli Lilly, Genzyme, Gilead, Grunenthal, GSK, HRA, Janssen, Lundbeck, MSD, Novartis, Otsuka, Pierre Fabre, Roche, Sanofi, Servier, Stallergene, UCB, ViiV. JF has received research support from Servier and AIMS-2-Trials project ID 777394. DR is an employee of Neurochlore. GO, SM, AR, AH, and MP report no conflict of interest. Index. décimale : PER Périodiques Résumé : There are currently no approved pharmacological treatments to improve social reciprocity and limit repetitive and rigid behaviors in autism spectrum disorder (ASD). We describe the design of two Phase III studies evaluating the efficacy/safety of bumetanide oral liquid formulation in ASD. These are international, multicenter, randomized, double-blind, placebo-controlled studies in children and adolescents with ASD aged 7 to 17 years (n?=?200; study 1), or younger children with ASD aged 2 to 6 years (n?=?200; study 2). The primary endpoint of each is change in Childhood Autism Rating Scale 2 total raw score after 6 months. These studies could contribute to the first pharmacological treatment to improve social reciprocity and limit repetitive and rigid behaviors in children and adolescents with ASD. En ligne : http://dx.doi.org/10.1007/s10803-020-04709-8 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=453
in Journal of Autism and Developmental Disorders > 51-8 (August 2021) . - p.2959-2972[article] Bumetanide Oral Liquid Formulation for the Treatment of Children and Adolescents with Autism Spectrum Disorder: Design of Two Phase III Studies (SIGN Trials) [Texte imprimé et/ou numérique] / V. CRUTEL, Auteur ; E. LAMBERT, Auteur ; P. F. PENELAUD, Auteur ; C. ALBARRÁN SEVERO, Auteur ; J. FUENTES, Auteur ; A. ROSIER, Auteur ; A. HERVAS, Auteur ; S. MARRET, Auteur ; G. OLIVEIRA, Auteur ; Mara PARELLADA, Auteur ; S. KYAGA, Auteur ; S. GOUTTEFANGEAS, Auteur ; M. BERTRAND, Auteur ; D. RAVEL, Auteur ; B. FALISSARD, Auteur . - p.2959-2972.
Langues : Anglais (eng)
in Journal of Autism and Developmental Disorders > 51-8 (August 2021) . - p.2959-2972
Mots-clés : Adolescent Autism Spectrum Disorder/drug therapy Bumetanide/administration & dosage/therapeutic use Child Child, Preschool Double-Blind Method Humans Male Research Design Social Behavior Treatment Outcome Autism spectrum disorder Bumetanide Pediatrics Randomized controlled trial for Actelion, Allergan, Almirall, Astellas, AstraZeneca, Bayer, Biotronik, BMS, Boehringer Ingelheim, Daiichi- Sankyo, Eli Lilly, Genzyme, Gilead, Grunenthal, GSK, HRA, Janssen, Lundbeck, MSD, Novartis, Otsuka, Pierre Fabre, Roche, Sanofi, Servier, Stallergene, UCB, ViiV. JF has received research support from Servier and AIMS-2-Trials project ID 777394. DR is an employee of Neurochlore. GO, SM, AR, AH, and MP report no conflict of interest. Index. décimale : PER Périodiques Résumé : There are currently no approved pharmacological treatments to improve social reciprocity and limit repetitive and rigid behaviors in autism spectrum disorder (ASD). We describe the design of two Phase III studies evaluating the efficacy/safety of bumetanide oral liquid formulation in ASD. These are international, multicenter, randomized, double-blind, placebo-controlled studies in children and adolescents with ASD aged 7 to 17 years (n?=?200; study 1), or younger children with ASD aged 2 to 6 years (n?=?200; study 2). The primary endpoint of each is change in Childhood Autism Rating Scale 2 total raw score after 6 months. These studies could contribute to the first pharmacological treatment to improve social reciprocity and limit repetitive and rigid behaviors in children and adolescents with ASD. En ligne : http://dx.doi.org/10.1007/s10803-020-04709-8 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=453 Case Report: Clozapine-Induced Myocarditis in a Patient with Autism Spectrum Disorder and Schizophrenia / Ganj BEEBANI in Journal of Autism and Developmental Disorders, 52-7 (July 2022)
Pharmacological and dietary-supplement treatments for autism spectrum disorder: a systematic review and network meta-analysis / Spyridon SIAFIS in Molecular Autism, 13 (2022)
PermalinkPractitioner Review: Pharmacological treatment of attention-deficit/hyperactivity disorder symptoms in children and youth with autism spectrum disorder: a systematic review and meta-analysis / R. RODRIGUES in Journal of Child Psychology and Psychiatry, 62-6 (June 2021)
PermalinkRandomized Controlled Trial of Omega-3 and -6 Fatty Acid Supplementation to Reduce Inflammatory Markers in Children with Autism Spectrum Disorder / Sarah A. KEIM in Journal of Autism and Developmental Disorders, 52-12 (December 2022)
PermalinkRisk of exposure to prescription opioids in children and adolescents with autism spectrum disorder: A nationwide longitudinal study / Ju-Wei HSU in Autism Research, 15-11 (November 2022)
PermalinkThe effects of JASPER intervention for children with autism spectrum disorder: A systematic review / H. WADDINGTON in Autism, 25-8 (November 2021)
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