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dc.contributor.authorVeenstra-VanderWeele, Jeremy
dc.contributor.authorCook, Edwin H
dc.contributor.authorKing, Bryan H
dc.contributor.authorZarevics, Peter
dc.contributor.authorCherubini, Maryann
dc.contributor.authorWalton-Bowen, Karen
dc.contributor.authorBear, Mark
dc.contributor.authorWang, Paul P
dc.contributor.authorCarpenter, Randall L
dc.date.accessioned2020-08-07T15:28:31Z
dc.date.available2020-08-07T15:28:31Z
dc.date.issued2016-10
dc.date.submitted2016-10
dc.identifier.issn0893-133X
dc.identifier.issn1740-634X
dc.identifier.urihttps://hdl.handle.net/1721.1/126510
dc.description.abstractSeveral lines of emerging data point to an imbalance between neuronal excitation and inhibition in at least a subgroup of individuals with autism spectrum disorder (ASD), including in those with fragile X syndrome (FXS), one of the most common genetic syndromes within ASD. In animal models of FXS and of ASD, GABA-B agonists have improved both brain and behavioral phenotypes, including social behavior. A phase 2 randomized, placebo-controlled, crossover trial found that the GABA-B agonist arbaclofen improved social avoidance symptoms in FXS. A pilot open-label trial of arbaclofen suggested similar benefits in ASD. We therefore evaluated arbaclofen in a randomized, placebo-controlled, phase 2 study of 150 participants, aged 5-21 years, with ASD. No difference from placebo was detected on the primary outcome measure, the parent-rated Aberrant Behavior Checklist Social Withdrawal/Lethargy subscale. However, a specified secondary analysis found improvement on the clinician-rated Clinical Global Impression of Severity. An exploratory post hoc analysis of participants with a consistent rater across the trial revealed greater improvement in the Vineland Adaptive Behavior Scales II socialization domain in participants receiving arbaclofen. Affect lability (11%) and sedation (9%) were the most common adverse events. In this exploratory study, secondary analyses suggest that arbaclofen may have the potential to improve symptoms in some children with ASD, but further study will be needed to replicate and extend these initial findings.en_US
dc.language.isoen
dc.publisherSpringer Science and Business Media LLCen_US
dc.relation.isversionofhttp://dx.doi.org/10.1038/npp.2016.237en_US
dc.rightsCreative Commons Attribution-Noncommercial-Share Alikeen_US
dc.rights.urihttp://creativecommons.org/licenses/by-nc-sa/4.0/en_US
dc.sourcePMCen_US
dc.titleArbaclofen in Children and Adolescents with Autism Spectrum Disorder: A Randomized, Controlled, Phase 2 Trialen_US
dc.typeArticleen_US
dc.identifier.citationVeenstra-VanderWeele, Jeremy et al. "Arbaclofen in Children and Adolescents with Autism Spectrum Disorder: A Randomized, Controlled, Phase 2 Trial." Neuropsychopharmacology 42, 7 (October 2016): 1390–1398 © 2017 American College of Neuropsychopharmacologyen_US
dc.contributor.departmentPicower Institute for Learning and Memoryen_US
dc.relation.journalNeuropsychopharmacologyen_US
dc.eprint.versionAuthor's final manuscripten_US
dc.type.urihttp://purl.org/eprint/type/JournalArticleen_US
eprint.statushttp://purl.org/eprint/status/PeerRevieweden_US
dc.date.updated2019-09-27T17:42:32Z
dspace.date.submission2019-09-27T17:42:33Z
mit.journal.volume42en_US
mit.journal.issue7en_US


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