title: Design and subject characteristics in the federally-funded citalopram trial in children with pervasive developmental disorders.
abstract: The Studies to Advance Autism Research and Treatment Network conducted a randomized trial with citalopram in children with Pervasive developmental disorders (PDDs). We present the rationale, design and sample characteristics of the citalopram trial. Subjects (128 boys, 21 girls) had a mean age of 9.3 (±3.12) years; 132 (88.6%) were diagnosed with autistic disorder (4.7% with Asperger's Disorder; 6.7% with PDD-not otherwise specified). Less than half of the subjects were intellectually disabled; 117 (78.5%) were rated Moderate or Marked on the Clinical Global Impression for Severity. Study measures were similar to previous Research Units on Pediatric Psychopharmacology trials. Subjects in this trial were slightly older and more likely to have complaints of repetitive behavior than participants in RUPP trials.
authors.affiliation: Yale University School of Nursing and Child Study Center, 230 S. Frontage Rd., New Haven, CT, USA. lawrence.scahill@yale.edu
authors.forename: Lawrence
authors.initials: L
authors.lastname: Scahill
authors.forename: James T
authors.initials: JT
authors.lastname: McCracken
authors.forename: Karen
authors.initials: K
authors.lastname: Bearss
authors.forename: Fay
authors.initials: F
authors.lastname: Robinson
authors.forename: Eric
authors.initials: E
authors.lastname: Hollander
authors.forename: Bryan
authors.initials: B
authors.lastname: King
authors.forename: Joel
authors.initials: J
authors.lastname: Bregman
authors.forename: Lin
authors.initials: L
authors.lastname: Sikich
authors.forename: Kimberly
authors.initials: K
authors.lastname: Dukes
authors.forename: Lisa
authors.initials: L
authors.lastname: Sullivan
authors.forename: Evdokia
authors.initials: E
authors.lastname: Anagnostou
authors.forename: Craig
authors.initials: C
authors.lastname: Donnelly
authors.forename: Young-Shin
authors.initials: YS
authors.lastname: Kim
authors.forename: Louise
authors.initials: L
authors.lastname: Ritz
authors.forename: Deborah
authors.initials: D
authors.lastname: Hirtz
authors.forename: Ann
authors.initials: A
authors.lastname: Wagner
mesh_terms: D000293:Adolescent; D002648:Child; D002659:Child Development Disorders, Pervasive / Q000188:drug therapy*; D015283:Citalopram / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009483:Neuropsychological Tests; D012107:Research Design; D035842:Research Subjects; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D015283:Citalopram; D017367:Selective Serotonin Reuptake Inhibitors