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Auteur H. LIU |
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Correction to: Randomized controlled trial of sulforaphane and metabolite discovery in children with Autism Spectrum Disorder / Andrew W. ZIMMERMAN in Molecular Autism, 12 (2021)
[article]
Titre : Correction to: Randomized controlled trial of sulforaphane and metabolite discovery in children with Autism Spectrum Disorder Type de document : Texte imprimé et/ou numérique Auteurs : Andrew W. ZIMMERMAN, Auteur ; K. SINGH, Auteur ; S. L. CONNORS, Auteur ; H. LIU, Auteur ; Anita A PANJWANI, Auteur ; L. C. LEE, Auteur ; E. DIGGINS, Auteur ; A. FOLEY, Auteur ; S. MELNYK, Auteur ; I. N. SINGH, Auteur ; S. JILL JAMES, Auteur ; R. E. FRYE, Auteur ; J. W. FAHEY, Auteur Article en page(s) : 44 p. Langues : Anglais (eng) Index. décimale : PER Périodiques En ligne : http://dx.doi.org/10.1186/s13229-021-00451-9 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=459
in Molecular Autism > 12 (2021) . - 44 p.[article] Correction to: Randomized controlled trial of sulforaphane and metabolite discovery in children with Autism Spectrum Disorder [Texte imprimé et/ou numérique] / Andrew W. ZIMMERMAN, Auteur ; K. SINGH, Auteur ; S. L. CONNORS, Auteur ; H. LIU, Auteur ; Anita A PANJWANI, Auteur ; L. C. LEE, Auteur ; E. DIGGINS, Auteur ; A. FOLEY, Auteur ; S. MELNYK, Auteur ; I. N. SINGH, Auteur ; S. JILL JAMES, Auteur ; R. E. FRYE, Auteur ; J. W. FAHEY, Auteur . - 44 p.
Langues : Anglais (eng)
in Molecular Autism > 12 (2021) . - 44 p.
Index. décimale : PER Périodiques En ligne : http://dx.doi.org/10.1186/s13229-021-00451-9 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=459 Randomized controlled trial of sulforaphane and metabolite discovery in children with Autism Spectrum Disorder / Andrew W. ZIMMERMAN in Molecular Autism, 12 (2021)
[article]
Titre : Randomized controlled trial of sulforaphane and metabolite discovery in children with Autism Spectrum Disorder Type de document : Texte imprimé et/ou numérique Auteurs : Andrew W. ZIMMERMAN, Auteur ; K. SINGH, Auteur ; S. L. CONNORS, Auteur ; H. LIU, Auteur ; Anita A PANJWANI, Auteur ; L. C. LEE, Auteur ; E. DIGGINS, Auteur ; A. FOLEY, Auteur ; S. MELNYK, Auteur ; I. N. SINGH, Auteur ; S. J. JAMES, Auteur ; R. E. FRYE, Auteur ; J. W. FAHEY, Auteur Article en page(s) : 38 p. Langues : Anglais (eng) Mots-clés : Autism spectrum disorder (ASD) Biomarkers Clinical trial Placebo effects Sulforaphane defendants in matters related to pediatric neurology and Autism Spectrum Disorder. JWF retired from the full-time faculty at Johns Hopkins in mid-2020, and now serves as a scientific advisor to Brassica Protection Products LLC (Baltimore, MD, USA), which produces a glucoraphanin-rich broccoli seed extract that it supplies to the supplement industry. AWZ is named on a patent on the use of sulforaphane for the treatment of autism that has been assigned to Johns Hopkins University. Index. décimale : PER Périodiques Résumé : BACKGROUND: Sulforaphane (SF), an isothiocyanate in broccoli, has potential benefits relevant to autism spectrum disorder (ASD) through its effects on several metabolic and immunologic pathways. Previous clinical trials of oral SF demonstrated positive clinical effects on behavior in young men and changes in urinary metabolomics in children with ASD. METHODS: We conducted a 15-week randomized parallel double-blind placebo-controlled clinical trial with 15-week open-label treatment and 6-week no-treatment extensions in 57 children, ages 3-12 years, with ASD over 36 weeks. Twenty-eight were assigned SF and 29 received placebo (PL). Clinical effects, safety and tolerability of SF were measured as were biomarkers to elucidate mechanisms of action of SF in ASD. RESULTS: Data from 22 children taking SF and 23 on PL were analyzed. Treatment effects on the primary outcome measure, the Ohio Autism Clinical Impressions Scale (OACIS), in the general level of autism were not significant between SF and PL groups at 7 and 15 weeks. The effect sizes on the OACIS were non-statistically significant but positive, suggesting a possible trend toward greater improvement in those on treatment with SF (Cohen's d 0.21; 95% CI -?0.46, 0.88 and 0.10; 95% CI -?0.52, 0.72, respectively). Both groups improved in all subscales when on SF during the open-label phase. Caregiver ratings on secondary outcome measures improved significantly on the Aberrant Behavior Checklist (ABC) at 15 weeks (Cohen's d -?0.96; 95% CI -?1.73, -?0.15), but not on the Social Responsiveness Scale-2 (SRS-2). Ratings on the ABC and SRS-2 improved with a non-randomized analysis of the length of exposure to SF, compared to the pre-treatment baseline (p?0.001). There were significant changes with SF compared to PL in biomarkers of glutathione redox status, mitochondrial respiration, inflammatory markers and heat shock proteins. Clinical laboratory studies confirmed product safety. SF was very well tolerated and side effects of treatment, none serious, included rare insomnia, irritability and intolerance of the taste and smell. LIMITATIONS: The sample size was limited to 45 children with ASD and we did not impute missing data. We were unable to document significant changes in clinical assessments during clinical visits in those taking SF compared to PL. The clinical results were confounded by placebo effects during the open-label phase. CONCLUSIONS: SF led to small yet non-statistically significant changes in the total and all subscale scores of the primary outcome measure, while for secondary outcome measures, caregivers' assessments of children taking SF showed statistically significant improvements compared to those taking PL on the ABC but not the SRS-2. Clinical effects of SF were less notable in children compared to our previous trial of a SF-rich preparation in young men with ASD. Several of the effects of SF on biomarkers correlated to clinical improvements. SF was very well tolerated and safe and effective based on our secondary clinical measures. TRIAL REGISTRATION: This study was prospectively registered at clinicaltrials.gov (NCT02561481) on September 28, 2015. Funding was provided by the U.S. Department of Defense. En ligne : http://dx.doi.org/10.1186/s13229-021-00447-5 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=459
in Molecular Autism > 12 (2021) . - 38 p.[article] Randomized controlled trial of sulforaphane and metabolite discovery in children with Autism Spectrum Disorder [Texte imprimé et/ou numérique] / Andrew W. ZIMMERMAN, Auteur ; K. SINGH, Auteur ; S. L. CONNORS, Auteur ; H. LIU, Auteur ; Anita A PANJWANI, Auteur ; L. C. LEE, Auteur ; E. DIGGINS, Auteur ; A. FOLEY, Auteur ; S. MELNYK, Auteur ; I. N. SINGH, Auteur ; S. J. JAMES, Auteur ; R. E. FRYE, Auteur ; J. W. FAHEY, Auteur . - 38 p.
Langues : Anglais (eng)
in Molecular Autism > 12 (2021) . - 38 p.
Mots-clés : Autism spectrum disorder (ASD) Biomarkers Clinical trial Placebo effects Sulforaphane defendants in matters related to pediatric neurology and Autism Spectrum Disorder. JWF retired from the full-time faculty at Johns Hopkins in mid-2020, and now serves as a scientific advisor to Brassica Protection Products LLC (Baltimore, MD, USA), which produces a glucoraphanin-rich broccoli seed extract that it supplies to the supplement industry. AWZ is named on a patent on the use of sulforaphane for the treatment of autism that has been assigned to Johns Hopkins University. Index. décimale : PER Périodiques Résumé : BACKGROUND: Sulforaphane (SF), an isothiocyanate in broccoli, has potential benefits relevant to autism spectrum disorder (ASD) through its effects on several metabolic and immunologic pathways. Previous clinical trials of oral SF demonstrated positive clinical effects on behavior in young men and changes in urinary metabolomics in children with ASD. METHODS: We conducted a 15-week randomized parallel double-blind placebo-controlled clinical trial with 15-week open-label treatment and 6-week no-treatment extensions in 57 children, ages 3-12 years, with ASD over 36 weeks. Twenty-eight were assigned SF and 29 received placebo (PL). Clinical effects, safety and tolerability of SF were measured as were biomarkers to elucidate mechanisms of action of SF in ASD. RESULTS: Data from 22 children taking SF and 23 on PL were analyzed. Treatment effects on the primary outcome measure, the Ohio Autism Clinical Impressions Scale (OACIS), in the general level of autism were not significant between SF and PL groups at 7 and 15 weeks. The effect sizes on the OACIS were non-statistically significant but positive, suggesting a possible trend toward greater improvement in those on treatment with SF (Cohen's d 0.21; 95% CI -?0.46, 0.88 and 0.10; 95% CI -?0.52, 0.72, respectively). Both groups improved in all subscales when on SF during the open-label phase. Caregiver ratings on secondary outcome measures improved significantly on the Aberrant Behavior Checklist (ABC) at 15 weeks (Cohen's d -?0.96; 95% CI -?1.73, -?0.15), but not on the Social Responsiveness Scale-2 (SRS-2). Ratings on the ABC and SRS-2 improved with a non-randomized analysis of the length of exposure to SF, compared to the pre-treatment baseline (p?0.001). There were significant changes with SF compared to PL in biomarkers of glutathione redox status, mitochondrial respiration, inflammatory markers and heat shock proteins. Clinical laboratory studies confirmed product safety. SF was very well tolerated and side effects of treatment, none serious, included rare insomnia, irritability and intolerance of the taste and smell. LIMITATIONS: The sample size was limited to 45 children with ASD and we did not impute missing data. We were unable to document significant changes in clinical assessments during clinical visits in those taking SF compared to PL. The clinical results were confounded by placebo effects during the open-label phase. CONCLUSIONS: SF led to small yet non-statistically significant changes in the total and all subscale scores of the primary outcome measure, while for secondary outcome measures, caregivers' assessments of children taking SF showed statistically significant improvements compared to those taking PL on the ABC but not the SRS-2. Clinical effects of SF were less notable in children compared to our previous trial of a SF-rich preparation in young men with ASD. Several of the effects of SF on biomarkers correlated to clinical improvements. SF was very well tolerated and safe and effective based on our secondary clinical measures. TRIAL REGISTRATION: This study was prospectively registered at clinicaltrials.gov (NCT02561481) on September 28, 2015. Funding was provided by the U.S. Department of Defense. En ligne : http://dx.doi.org/10.1186/s13229-021-00447-5 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=459 A randomized, placebo-controlled trial of D-cycloserine for the enhancement of social skills training in autism spectrum disorders / N. F. MINSHAWI in Molecular Autism, 7 (2016)
[article]
Titre : A randomized, placebo-controlled trial of D-cycloserine for the enhancement of social skills training in autism spectrum disorders Type de document : Texte imprimé et/ou numérique Auteurs : N. F. MINSHAWI, Auteur ; L. K. WINK, Auteur ; R. SHAFFER, Auteur ; M. H. PLAWECKI, Auteur ; D. J. POSEY, Auteur ; H. LIU, Auteur ; S. HURWITZ, Auteur ; C. J. MCDOUGLE, Auteur ; N. B. SWIEZY, Auteur ; C. A. ERICKSON, Auteur Article en page(s) : 2p. Langues : Anglais (eng) Mots-clés : Autism Spectrum Disorder/drug therapy/psychology/therapy Behavior Therapy Child Child, Preschool Cycloserine/adverse effects/therapeutic use Double-Blind Method Excitatory Amino Acid Agonists/adverse effects/therapeutic use Female Humans Interpersonal Relations Learning/drug effects Male Parents/psychology Severity of Illness Index Social Skills Treatment Failure Autism spectrum disorders Social deficits Social skills training d-cycloserine Index. décimale : PER Périodiques Résumé : BACKGROUND: Researchers have demonstrated that d-cycloserine (DCS) can enhance the effects of behavioral interventions in adults with anxiety and enhances prosocial behavior in animal models of autism spectrum disorders (ASD). This study extended upon this background by combining DCS with behavioral social skills therapy in youth with ASD to assess its impact on the core social deficits of ASD. We hypothesized that DCS used in combination with social skills training would enhance the acquisition of social skills in children with ASD. METHODS: A 10-week, double-blind, placebo-controlled trial of DCS (50 mg) given 30 min prior to weekly group social skills training was conducted at two sites. Children with ASD were randomized to receive 10 weeks (10 doses) of DCS or placebo in a 1:1 ratio. RESULTS: No statistically significant difference attributable to drug treatment was observed in the change scores for the primary outcome measure, the Social Responsiveness Scale (SRS), total score (p = 0.45), or on secondary outcome measures. CONCLUSIONS: The results of this trial demonstrated no drug-related short-term improvement on the primary outcome measure, or any of the secondary outcome measures. However, an overall significant improvement in SRS total raw score was observed from baseline to end of treatment for the entire group of children with ASD. This suggests a need to further study the efficacy of the social skills training protocol. Limitations to the current study and areas for future research are discussed. TRIAL REGISTRATION: ClinicalTrials.govNCT01086475. En ligne : http://dx.doi.org/10.1186/s13229-015-0062-8 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=328
in Molecular Autism > 7 (2016) . - 2p.[article] A randomized, placebo-controlled trial of D-cycloserine for the enhancement of social skills training in autism spectrum disorders [Texte imprimé et/ou numérique] / N. F. MINSHAWI, Auteur ; L. K. WINK, Auteur ; R. SHAFFER, Auteur ; M. H. PLAWECKI, Auteur ; D. J. POSEY, Auteur ; H. LIU, Auteur ; S. HURWITZ, Auteur ; C. J. MCDOUGLE, Auteur ; N. B. SWIEZY, Auteur ; C. A. ERICKSON, Auteur . - 2p.
Langues : Anglais (eng)
in Molecular Autism > 7 (2016) . - 2p.
Mots-clés : Autism Spectrum Disorder/drug therapy/psychology/therapy Behavior Therapy Child Child, Preschool Cycloserine/adverse effects/therapeutic use Double-Blind Method Excitatory Amino Acid Agonists/adverse effects/therapeutic use Female Humans Interpersonal Relations Learning/drug effects Male Parents/psychology Severity of Illness Index Social Skills Treatment Failure Autism spectrum disorders Social deficits Social skills training d-cycloserine Index. décimale : PER Périodiques Résumé : BACKGROUND: Researchers have demonstrated that d-cycloserine (DCS) can enhance the effects of behavioral interventions in adults with anxiety and enhances prosocial behavior in animal models of autism spectrum disorders (ASD). This study extended upon this background by combining DCS with behavioral social skills therapy in youth with ASD to assess its impact on the core social deficits of ASD. We hypothesized that DCS used in combination with social skills training would enhance the acquisition of social skills in children with ASD. METHODS: A 10-week, double-blind, placebo-controlled trial of DCS (50 mg) given 30 min prior to weekly group social skills training was conducted at two sites. Children with ASD were randomized to receive 10 weeks (10 doses) of DCS or placebo in a 1:1 ratio. RESULTS: No statistically significant difference attributable to drug treatment was observed in the change scores for the primary outcome measure, the Social Responsiveness Scale (SRS), total score (p = 0.45), or on secondary outcome measures. CONCLUSIONS: The results of this trial demonstrated no drug-related short-term improvement on the primary outcome measure, or any of the secondary outcome measures. However, an overall significant improvement in SRS total raw score was observed from baseline to end of treatment for the entire group of children with ASD. This suggests a need to further study the efficacy of the social skills training protocol. Limitations to the current study and areas for future research are discussed. TRIAL REGISTRATION: ClinicalTrials.govNCT01086475. En ligne : http://dx.doi.org/10.1186/s13229-015-0062-8 Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=328