title: Extended-Release Guanfacine for Hyperactivity in Children With Autism Spectrum Disorder.
abstract: OBJECTIVE
  Hyperactivity, impulsiveness, and distractibility are common problems in children with autism spectrum disorder (ASD). Extended-release guanfacine is approved for children with attention deficit hyperactivity disorder but not well studied in ASD.
  
  
  METHODS
  In a multisite, randomized clinical trial, extended-release guanfacine was compared with placebo in children with ASD accompanied by hyperactivity, impulsiveness, and distractibility.
  
  
  RESULTS
  Sixty-two subjects (boys, N=53; girls, N=9; mean age=8.5 years [SD=2.25]) were randomly assigned to guanfacine (N=30) or placebo (N=32) for 8 weeks. The guanfacine group showed a 43.6% decline in scores on the Aberrant Behavior Checklist-hyperactivity subscale (least squares mean from 34.2 to 19.3) compared with a 13.2% decrease in the placebo group (least squares mean from 34.2 to 29.7; effect size=1.67). The rate of positive response (much improved or very much improved on the Clinical Global Impression-Improvement scale) was 50% (15 of 30) for guanfacine compared with 9.4% (3 of 32) for placebo. A brief cognitive battery tapping working memory and motor planning showed no group differences before or after 8 weeks of treatment. The modal dose of guanfacine at week 8 was 3 mg/day (range: 1-4 mg/day), and the modal dose was 3 mg/day (range: 2-4 mg/day) for placebo. Four guanfacine-treated subjects (13.3%) and four placebo subjects (12.5%) exited the study before week 8. The most common adverse events included drowsiness, fatigue, and decreased appetite. There were no significant changes on ECG in either group. For subjects in the guanfacine group, blood pressure declined in the first 4 weeks, with return nearly to baseline by endpoint (week 8). Pulse rate showed a similar pattern but remained lower than baseline at endpoint.
  
  
  CONCLUSIONS
  Extended-release guanfacine appears to be safe and effective for reducing hyperactivity, impulsiveness, and distractibility in children with ASD.
authors: From the Department of Pediatrics, Emory University School of Medicine, Atlanta; the Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles; the Department of Psychiatry and Behavioral Sciences, Seattle Children's Hospital, Seattle, Wash.; the Department of Child and Adolescent Psychiatry, Lurie Center for Autism, Massachusetts General Hospital, Lexington, Mass.; the Marcus Autism Center, Atlanta; the Department of Biostatistics, Yale University, New Haven, Conn.; the Department of Emergency Medicine, Yale University, New Haven, Conn.; the Department of Psychiatry, Massachusetts General Hospital, Boston; and the David Geffen School of Medicine, University of California, Los Angeles.
authors: Lawrence
authors: L
authors: Scahill
authors: From the Department of Pediatrics, Emory University School of Medicine, Atlanta; the Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles; the Department of Psychiatry and Behavioral Sciences, Seattle Children's Hospital, Seattle, Wash.; the Department of Child and Adolescent Psychiatry, Lurie Center for Autism, Massachusetts General Hospital, Lexington, Mass.; the Marcus Autism Center, Atlanta; the Department of Biostatistics, Yale University, New Haven, Conn.; the Department of Emergency Medicine, Yale University, New Haven, Conn.; the Department of Psychiatry, Massachusetts General Hospital, Boston; and the David Geffen School of Medicine, University of California, Los Angeles.
authors: James T
authors: JT
authors: McCracken
authors: From the Department of Pediatrics, Emory University School of Medicine, Atlanta; the Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles; the Department of Psychiatry and Behavioral Sciences, Seattle Children's Hospital, Seattle, Wash.; the Department of Child and Adolescent Psychiatry, Lurie Center for Autism, Massachusetts General Hospital, Lexington, Mass.; the Marcus Autism Center, Atlanta; the Department of Biostatistics, Yale University, New Haven, Conn.; the Department of Emergency Medicine, Yale University, New Haven, Conn.; the Department of Psychiatry, Massachusetts General Hospital, Boston; and the David Geffen School of Medicine, University of California, Los Angeles.
authors: Bryan H
authors: BH
authors: King
authors: From the Department of Pediatrics, Emory University School of Medicine, Atlanta; the Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles; the Department of Psychiatry and Behavioral Sciences, Seattle Children's Hospital, Seattle, Wash.; the Department of Child and Adolescent Psychiatry, Lurie Center for Autism, Massachusetts General Hospital, Lexington, Mass.; the Marcus Autism Center, Atlanta; the Department of Biostatistics, Yale University, New Haven, Conn.; the Department of Emergency Medicine, Yale University, New Haven, Conn.; the Department of Psychiatry, Massachusetts General Hospital, Boston; and the David Geffen School of Medicine, University of California, Los Angeles.
authors: Carol
authors: C
authors: Rockhill
authors: From the Department of Pediatrics, Emory University School of Medicine, Atlanta; the Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles; the Department of Psychiatry and Behavioral Sciences, Seattle Children's Hospital, Seattle, Wash.; the Department of Child and Adolescent Psychiatry, Lurie Center for Autism, Massachusetts General Hospital, Lexington, Mass.; the Marcus Autism Center, Atlanta; the Department of Biostatistics, Yale University, New Haven, Conn.; the Department of Emergency Medicine, Yale University, New Haven, Conn.; the Department of Psychiatry, Massachusetts General Hospital, Boston; and the David Geffen School of Medicine, University of California, Los Angeles.
authors: Bhavik
authors: B
authors: Shah
authors: From the Department of Pediatrics, Emory University School of Medicine, Atlanta; the Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles; the Department of Psychiatry and Behavioral Sciences, Seattle Children's Hospital, Seattle, Wash.; the Department of Child and Adolescent Psychiatry, Lurie Center for Autism, Massachusetts General Hospital, Lexington, Mass.; the Marcus Autism Center, Atlanta; the Department of Biostatistics, Yale University, New Haven, Conn.; the Department of Emergency Medicine, Yale University, New Haven, Conn.; the Department of Psychiatry, Massachusetts General Hospital, Boston; and the David Geffen School of Medicine, University of California, Los Angeles.
authors: Laura
authors: L
authors: Politte
authors: From the Department of Pediatrics, Emory University School of Medicine, Atlanta; the Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles; the Department of Psychiatry and Behavioral Sciences, Seattle Children's Hospital, Seattle, Wash.; the Department of Child and Adolescent Psychiatry, Lurie Center for Autism, Massachusetts General Hospital, Lexington, Mass.; the Marcus Autism Center, Atlanta; the Department of Biostatistics, Yale University, New Haven, Conn.; the Department of Emergency Medicine, Yale University, New Haven, Conn.; the Department of Psychiatry, Massachusetts General Hospital, Boston; and the David Geffen School of Medicine, University of California, Los Angeles.
authors: Roy
authors: R
authors: Sanders
authors: From the Department of Pediatrics, Emory University School of Medicine, Atlanta; the Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles; the Department of Psychiatry and Behavioral Sciences, Seattle Children's Hospital, Seattle, Wash.; the Department of Child and Adolescent Psychiatry, Lurie Center for Autism, Massachusetts General Hospital, Lexington, Mass.; the Marcus Autism Center, Atlanta; the Department of Biostatistics, Yale University, New Haven, Conn.; the Department of Emergency Medicine, Yale University, New Haven, Conn.; the Department of Psychiatry, Massachusetts General Hospital, Boston; and the David Geffen School of Medicine, University of California, Los Angeles.
authors: Mendy
authors: M
authors: Minjarez
authors: From the Department of Pediatrics, Emory University School of Medicine, Atlanta; the Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles; the Department of Psychiatry and Behavioral Sciences, Seattle Children's Hospital, Seattle, Wash.; the Department of Child and Adolescent Psychiatry, Lurie Center for Autism, Massachusetts General Hospital, Lexington, Mass.; the Marcus Autism Center, Atlanta; the Department of Biostatistics, Yale University, New Haven, Conn.; the Department of Emergency Medicine, Yale University, New Haven, Conn.; the Department of Psychiatry, Massachusetts General Hospital, Boston; and the David Geffen School of Medicine, University of California, Los Angeles.
authors: Jennifer
authors: J
authors: Cowen
authors: From the Department of Pediatrics, Emory University School of Medicine, Atlanta; the Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles; the Department of Psychiatry and Behavioral Sciences, Seattle Children's Hospital, Seattle, Wash.; the Department of Child and Adolescent Psychiatry, Lurie Center for Autism, Massachusetts General Hospital, Lexington, Mass.; the Marcus Autism Center, Atlanta; the Department of Biostatistics, Yale University, New Haven, Conn.; the Department of Emergency Medicine, Yale University, New Haven, Conn.; the Department of Psychiatry, Massachusetts General Hospital, Boston; and the David Geffen School of Medicine, University of California, Los Angeles.
authors: Jennifer
authors: J
authors: Mullett
authors: From the Department of Pediatrics, Emory University School of Medicine, Atlanta; the Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles; the Department of Psychiatry and Behavioral Sciences, Seattle Children's Hospital, Seattle, Wash.; the Department of Child and Adolescent Psychiatry, Lurie Center for Autism, Massachusetts General Hospital, Lexington, Mass.; the Marcus Autism Center, Atlanta; the Department of Biostatistics, Yale University, New Haven, Conn.; the Department of Emergency Medicine, Yale University, New Haven, Conn.; the Department of Psychiatry, Massachusetts General Hospital, Boston; and the David Geffen School of Medicine, University of California, Los Angeles.
authors: Chris
authors: C
authors: Page
authors: From the Department of Pediatrics, Emory University School of Medicine, Atlanta; the Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles; the Department of Psychiatry and Behavioral Sciences, Seattle Children's Hospital, Seattle, Wash.; the Department of Child and Adolescent Psychiatry, Lurie Center for Autism, Massachusetts General Hospital, Lexington, Mass.; the Marcus Autism Center, Atlanta; the Department of Biostatistics, Yale University, New Haven, Conn.; the Department of Emergency Medicine, Yale University, New Haven, Conn.; the Department of Psychiatry, Massachusetts General Hospital, Boston; and the David Geffen School of Medicine, University of California, Los Angeles.
authors: Denise
authors: D
authors: Ward
authors: From the Department of Pediatrics, Emory University School of Medicine, Atlanta; the Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles; the Department of Psychiatry and Behavioral Sciences, Seattle Children's Hospital, Seattle, Wash.; the Department of Child and Adolescent Psychiatry, Lurie Center for Autism, Massachusetts General Hospital, Lexington, Mass.; the Marcus Autism Center, Atlanta; the Department of Biostatistics, Yale University, New Haven, Conn.; the Department of Emergency Medicine, Yale University, New Haven, Conn.; the Department of Psychiatry, Massachusetts General Hospital, Boston; and the David Geffen School of Medicine, University of California, Los Angeles.
authors: Yanhong
authors: Y
authors: Deng
authors: From the Department of Pediatrics, Emory University School of Medicine, Atlanta; the Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles; the Department of Psychiatry and Behavioral Sciences, Seattle Children's Hospital, Seattle, Wash.; the Department of Child and Adolescent Psychiatry, Lurie Center for Autism, Massachusetts General Hospital, Lexington, Mass.; the Marcus Autism Center, Atlanta; the Department of Biostatistics, Yale University, New Haven, Conn.; the Department of Emergency Medicine, Yale University, New Haven, Conn.; the Department of Psychiatry, Massachusetts General Hospital, Boston; and the David Geffen School of Medicine, University of California, Los Angeles.
authors: Sandra
authors: S
authors: Loo
authors: From the Department of Pediatrics, Emory University School of Medicine, Atlanta; the Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles; the Department of Psychiatry and Behavioral Sciences, Seattle Children's Hospital, Seattle, Wash.; the Department of Child and Adolescent Psychiatry, Lurie Center for Autism, Massachusetts General Hospital, Lexington, Mass.; the Marcus Autism Center, Atlanta; the Department of Biostatistics, Yale University, New Haven, Conn.; the Department of Emergency Medicine, Yale University, New Haven, Conn.; the Department of Psychiatry, Massachusetts General Hospital, Boston; and the David Geffen School of Medicine, University of California, Los Angeles.
authors: James
authors: J
authors: Dziura
authors: From the Department of Pediatrics, Emory University School of Medicine, Atlanta; the Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles; the Department of Psychiatry and Behavioral Sciences, Seattle Children's Hospital, Seattle, Wash.; the Department of Child and Adolescent Psychiatry, Lurie Center for Autism, Massachusetts General Hospital, Lexington, Mass.; the Marcus Autism Center, Atlanta; the Department of Biostatistics, Yale University, New Haven, Conn.; the Department of Emergency Medicine, Yale University, New Haven, Conn.; the Department of Psychiatry, Massachusetts General Hospital, Boston; and the David Geffen School of Medicine, University of California, Los Angeles.
authors: Christopher J
authors: CJ
authors: McDougle
mesh_terms: D000293:Adolescent; D058647:Adrenergic alpha-2 Receptor Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D000067877:Autism Spectrum Disorder / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D002648:Child; D002675:Child, Preschool; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D016316:Guanfacine / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D006948:Hyperkinesis / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D008297:Male; D008570:Memory, Short-Term / Q000187:drug effects; D009483:Neuropsychological Tests; D011597:Psychomotor Performance / Q000187:drug effects; D016896:Treatment Outcome
chemical_list: D058647:Adrenergic alpha-2 Receptor Agonists; D003692:Delayed-Action Preparations; D016316:Guanfacine