STX209 (Arbaclofen) for Autism Spectrum Disorders: An 8-Week Open-Label Study / Craig ERICKSON in Journal of Autism and Developmental Disorders, 44-4 (April 2014)  

Public ISBD [article]  inJournal of Autism and Developmental Disorders > 44-4 (April 2014) . - p.958-964 Titre : STX209 (Arbaclofen) for Autism Spectrum Disorders: An 8-Week Open-Label Study Type de document : texte imprimé Auteurs : Craig ERICKSON, Auteur ; Jeremy M. VEENSTRA-VANDERWEELE, Auteur ; Raun D. MELMED, Auteur ; James T. MCCRACKEN, Auteur ; Lawrence D. GINSBERG, Auteur ; Linmarie SIKICH, Auteur ; Lawrence SCAHILL, Auteur ; Maryann CHERUBINI, Auteur ; Peter ZAREVICS, Auteur ; Karen WALTON-BOWEN, Auteur ; Randall L. CARPENTER, Auteur ; Mark F. BEAR, Auteur ; Paul P. WANG, Auteur ; Bryan H. KING, Auteur Année de publication : 2014 Article en page(s) : p.958-964 Langues : Anglais (eng) Mots-clés : STX209  Arbaclofen  Gamma-aminobutyric acid (GABA)  Autism spectrum disorder  Clinical trial Index. décimale : PER Périodiques Résumé : STX209 (arbaclofen), a selective GABA-B agonist, is hypothesized to modulate the balance of excitatory to inhibitory neurotransmission, and has shown preliminary evidence of benefit in fragile X syndrome. We evaluated its safety, tolerability, and efficacy in non-syndromic autism spectrum disorders, in an 8-week open-label trial enrolling 32 children and adolescents with either Autistic Disorder or Pervasive Developmental Disorder—Not Otherwise Specified, and a score ≥17 on the Aberrant Behavior Checklist (ABC)—Irritability subscale. STX209 was generally well-tolerated. The most common adverse events were agitation and irritability, which typically resolved without dose changes, and were often felt to represent spontaneous variation in underlying symptoms. Improvements were observed on several outcome measures in this exploratory trial, including the ABC-Irritability (the primary endpoint) and the Lethargy/Social Withdrawal subscales, the Social Responsiveness Scale, the CY-BOCS-PDD, and clinical global impression scales. Placebo-controlled study of STX209 is warranted. En ligne : http://dx.doi.org/10.1007/s10803-013-1963-z Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=228 [article] STX209 (Arbaclofen) for Autism Spectrum Disorders: An 8-Week Open-Label Study [texte imprimé] / Craig ERICKSON, Auteur ; Jeremy M. VEENSTRA-VANDERWEELE, Auteur ; Raun D. MELMED, Auteur ; James T. MCCRACKEN, Auteur ; Lawrence D. GINSBERG, Auteur ; Linmarie SIKICH, Auteur ; Lawrence SCAHILL, Auteur ; Maryann CHERUBINI, Auteur ; Peter ZAREVICS, Auteur ; Karen WALTON-BOWEN, Auteur ; Randall L. CARPENTER, Auteur ; Mark F. BEAR, Auteur ; Paul P. WANG, Auteur ; Bryan H. KING, Auteur . - 2014 . - p.958-964. Langues : Anglais (eng) in Journal of Autism and Developmental Disorders > 44-4 (April 2014) . - p.958-964 Mots-clés : STX209  Arbaclofen  Gamma-aminobutyric acid (GABA)  Autism spectrum disorder  Clinical trial Index. décimale : PER Périodiques Résumé : STX209 (arbaclofen), a selective GABA-B agonist, is hypothesized to modulate the balance of excitatory to inhibitory neurotransmission, and has shown preliminary evidence of benefit in fragile X syndrome. We evaluated its safety, tolerability, and efficacy in non-syndromic autism spectrum disorders, in an 8-week open-label trial enrolling 32 children and adolescents with either Autistic Disorder or Pervasive Developmental Disorder—Not Otherwise Specified, and a score ≥17 on the Aberrant Behavior Checklist (ABC)—Irritability subscale. STX209 was generally well-tolerated. The most common adverse events were agitation and irritability, which typically resolved without dose changes, and were often felt to represent spontaneous variation in underlying symptoms. Improvements were observed on several outcome measures in this exploratory trial, including the ABC-Irritability (the primary endpoint) and the Lethargy/Social Withdrawal subscales, the Social Responsiveness Scale, the CY-BOCS-PDD, and clinical global impression scales. Placebo-controlled study of STX209 is warranted. En ligne : http://dx.doi.org/10.1007/s10803-013-1963-z Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=228

The SOFIA Study: Negative Multi-center Study of Low Dose Fluoxetine on Repetitive Behaviors in Children and Adolescents with Autistic Disorder / Paul HERSCU in Journal of Autism and Developmental Disorders, 50-9 (September 2020)  

Public ISBD [article]  inJournal of Autism and Developmental Disorders > 50-9 (September 2020) . - p.3233-3244 Titre : The SOFIA Study: Negative Multi-center Study of Low Dose Fluoxetine on Repetitive Behaviors in Children and Adolescents with Autistic Disorder Type de document : texte imprimé Auteurs : Paul HERSCU, Auteur ; Benjamin L. HANDEN, Auteur ; L. Eugene ARNOLD, Auteur ; Michael F. SNAPE, Auteur ; Joel D. BREGMAN, Auteur ; Lawrence D. GINSBERG, Auteur ; Robert L. HENDREN, Auteur ; Alexander KOLEVZON, Auteur ; Raun D. MELMED, Auteur ; Mark MINTZ, Auteur ; Nancy J. MINSHEW, Auteur ; Linmarie SIKICH, Auteur ; Ashraf ATTALLA, Auteur ; Brian KING, Auteur ; Thomas OWLEY, Auteur ; Ann CHILDRESS, Auteur ; Harry CHUGANI, Auteur ; Jean A. FRAZIER, Auteur ; Charles CARTWRIGHT, Auteur ; Tanya K. MURPHY, Auteur Article en page(s) : p.3233-3244 Langues : Anglais (eng) Mots-clés : Autism spectrum disorder  Repetitive behavior  Selective seretonin reuptake inhibitor Index. décimale : PER Périodiques Résumé : Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) that reduces obsessive-compulsive symptoms. There is limited evidence supporting its efficacy for repetitive behaviors (RRBs) in autistic spectrum disorder (ASD). We conducted a randomized controlled trial (RCT) of fluoxetine in 158 individuals with ASD (5-17 years). Following 14 treatment weeks (mean dose 11.8 mg/day), no significant differences were noted on the Children's Yale-Brown Obsessive Compulsive Scale; the proportion of responders was similar (fluoxetine: 36%; placebo: 41%). There were similar rates of AEs (e.g., insomnia, diarrhea, vomiting); high rates of activation were reported in both groups (fluoxetine: 42%; placebo: 45%). Overly cautious dosing/duration may have prevented attainment of a therapeutic level. Results are consistent with other SSRI RCTs treating RRBs in ASD.Trial Registration: clinicaltrials.gov Identifier: NCT00515320. En ligne : http://dx.doi.org/10.1007/s10803-019-04120-y Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=430 [article] The SOFIA Study: Negative Multi-center Study of Low Dose Fluoxetine on Repetitive Behaviors in Children and Adolescents with Autistic Disorder [texte imprimé] / Paul HERSCU, Auteur ; Benjamin L. HANDEN, Auteur ; L. Eugene ARNOLD, Auteur ; Michael F. SNAPE, Auteur ; Joel D. BREGMAN, Auteur ; Lawrence D. GINSBERG, Auteur ; Robert L. HENDREN, Auteur ; Alexander KOLEVZON, Auteur ; Raun D. MELMED, Auteur ; Mark MINTZ, Auteur ; Nancy J. MINSHEW, Auteur ; Linmarie SIKICH, Auteur ; Ashraf ATTALLA, Auteur ; Brian KING, Auteur ; Thomas OWLEY, Auteur ; Ann CHILDRESS, Auteur ; Harry CHUGANI, Auteur ; Jean A. FRAZIER, Auteur ; Charles CARTWRIGHT, Auteur ; Tanya K. MURPHY, Auteur . - p.3233-3244. Langues : Anglais (eng) in Journal of Autism and Developmental Disorders > 50-9 (September 2020) . - p.3233-3244 Mots-clés : Autism spectrum disorder  Repetitive behavior  Selective seretonin reuptake inhibitor Index. décimale : PER Périodiques Résumé : Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) that reduces obsessive-compulsive symptoms. There is limited evidence supporting its efficacy for repetitive behaviors (RRBs) in autistic spectrum disorder (ASD). We conducted a randomized controlled trial (RCT) of fluoxetine in 158 individuals with ASD (5-17 years). Following 14 treatment weeks (mean dose 11.8 mg/day), no significant differences were noted on the Children's Yale-Brown Obsessive Compulsive Scale; the proportion of responders was similar (fluoxetine: 36%; placebo: 41%). There were similar rates of AEs (e.g., insomnia, diarrhea, vomiting); high rates of activation were reported in both groups (fluoxetine: 42%; placebo: 45%). Overly cautious dosing/duration may have prevented attainment of a therapeutic level. Results are consistent with other SSRI RCTs treating RRBs in ASD.Trial Registration: clinicaltrials.gov Identifier: NCT00515320. En ligne : http://dx.doi.org/10.1007/s10803-019-04120-y Permalink : https://www.cra-rhone-alpes.org/cid/opac_css/index.php?lvl=notice_display&id=430

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