title: Efficacy and safety of immediate-release methylphenidate treatment for preschoolers with ADHD.
abstract: OBJECTIVE
  The Preschool ADHD Treatment Study (PATS) was a NIMH-funded, six-center, randomized, controlled trial to determine the efficacy and safety of immediate-release methylphenidate (MPH-IR), given t.i.d. to children ages 3 to 5.5 years with attention-deficit/hyperactivity disorder (ADHD).
  
  
  METHODS
  The 8-phase, 70-week PATS protocol included two double-blind, controlled phases, a crossover-titration trial followed by a placebo-controlled parallel trial. The crossover-titration phase's primary efficacy measure was a combined score from the Swanson, Kotkin, Atkins, M-Flynn, and Pelham (SKAMP) plus the Conners, Loney, and Milich (CLAM) rating scales; the parallel phase's primary outcome measure was excellent response, based on composite scores on the Swanson, Nolan, and Pelham (SNAP) rating scale.
  
  
  RESULTS
  Of 303 preschoolers enrolled, 165 were randomized into the titration trial. Compared with placebo, significant decreases in ADHD symptoms were found on MPH at 2.5 mg (p<.01), 5 mg (p<.001), and 7.5 mg (p<.001) t.i.d. doses, but not for 1.25 mg (p<.06). The mean optimal MPH total daily dose for the entire group was 14.2 +/- 8.1 mg/day (0.7+/-0.4 mg/kg/day). For the preschoolers (n=114) later randomized into the parallel phase, only 21% on best-dose MPH and 13% on placebo achieved MTA-defined categorical criterion for remission set for school-age children with ADHD.
  
  
  CONCLUSIONS
  MPH-IR, delivered in 2.5-, 5-, and 7.5-mg doses t.i.d., produced significant reductions on ADHD symptom scales in preschoolers compared to placebo, although effect sizes (0.4-0.8) were smaller than those cited for school-age children on the same medication.
authors.affiliation: Dr. Greenhill and Posner, Mr. Davies, Mr. Cooper, Ms. Skrobala, and Ms. Chuang are with the New York State Psychiatric Institute/Columbia University; Dr. Kollins is with Duke University, Durham, NC; Dr. Abikoff is with the New York University Child Study Center, New York; Dr. Riddle is with Johns Hopkins University, Baltimore; Dr. Ghuman is with the University of Arizona, Tucson; Dr. Cunningham is with McMaster University, Hamilton, Ontario, Canada; Drs. McCracken and McGough are with the University of California, Los Angeles; Drs. Swanson, T. Wigal, and S. Wigal are with the University of California, Irvine; and Mr. Cooper is also with the Nathan Kline Institute, Orangeburg, NY; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD.. Electronic address: greenhil@childpysch.columbia.edu.
authors.forename: Laurence
authors.initials: L
authors.lastname: Greenhill
authors.affiliation: Dr. Greenhill and Posner, Mr. Davies, Mr. Cooper, Ms. Skrobala, and Ms. Chuang are with the New York State Psychiatric Institute/Columbia University; Dr. Kollins is with Duke University, Durham, NC; Dr. Abikoff is with the New York University Child Study Center, New York; Dr. Riddle is with Johns Hopkins University, Baltimore; Dr. Ghuman is with the University of Arizona, Tucson; Dr. Cunningham is with McMaster University, Hamilton, Ontario, Canada; Drs. McCracken and McGough are with the University of California, Los Angeles; Drs. Swanson, T. Wigal, and S. Wigal are with the University of California, Irvine; and Mr. Cooper is also with the Nathan Kline Institute, Orangeburg, NY; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD.
authors.forename: Scott
authors.initials: S
authors.lastname: Kollins
authors.affiliation: Dr. Greenhill and Posner, Mr. Davies, Mr. Cooper, Ms. Skrobala, and Ms. Chuang are with the New York State Psychiatric Institute/Columbia University; Dr. Kollins is with Duke University, Durham, NC; Dr. Abikoff is with the New York University Child Study Center, New York; Dr. Riddle is with Johns Hopkins University, Baltimore; Dr. Ghuman is with the University of Arizona, Tucson; Dr. Cunningham is with McMaster University, Hamilton, Ontario, Canada; Drs. McCracken and McGough are with the University of California, Los Angeles; Drs. Swanson, T. Wigal, and S. Wigal are with the University of California, Irvine; and Mr. Cooper is also with the Nathan Kline Institute, Orangeburg, NY; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD.
authors.forename: Howard
authors.initials: H
authors.lastname: Abikoff
authors.affiliation: Dr. Greenhill and Posner, Mr. Davies, Mr. Cooper, Ms. Skrobala, and Ms. Chuang are with the New York State Psychiatric Institute/Columbia University; Dr. Kollins is with Duke University, Durham, NC; Dr. Abikoff is with the New York University Child Study Center, New York; Dr. Riddle is with Johns Hopkins University, Baltimore; Dr. Ghuman is with the University of Arizona, Tucson; Dr. Cunningham is with McMaster University, Hamilton, Ontario, Canada; Drs. McCracken and McGough are with the University of California, Los Angeles; Drs. Swanson, T. Wigal, and S. Wigal are with the University of California, Irvine; and Mr. Cooper is also with the Nathan Kline Institute, Orangeburg, NY; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD.
authors.forename: James
authors.initials: J
authors.lastname: McCracken
authors.affiliation: Dr. Greenhill and Posner, Mr. Davies, Mr. Cooper, Ms. Skrobala, and Ms. Chuang are with the New York State Psychiatric Institute/Columbia University; Dr. Kollins is with Duke University, Durham, NC; Dr. Abikoff is with the New York University Child Study Center, New York; Dr. Riddle is with Johns Hopkins University, Baltimore; Dr. Ghuman is with the University of Arizona, Tucson; Dr. Cunningham is with McMaster University, Hamilton, Ontario, Canada; Drs. McCracken and McGough are with the University of California, Los Angeles; Drs. Swanson, T. Wigal, and S. Wigal are with the University of California, Irvine; and Mr. Cooper is also with the Nathan Kline Institute, Orangeburg, NY; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD.
authors.forename: Mark
authors.initials: M
authors.lastname: Riddle
authors.affiliation: Dr. Greenhill and Posner, Mr. Davies, Mr. Cooper, Ms. Skrobala, and Ms. Chuang are with the New York State Psychiatric Institute/Columbia University; Dr. Kollins is with Duke University, Durham, NC; Dr. Abikoff is with the New York University Child Study Center, New York; Dr. Riddle is with Johns Hopkins University, Baltimore; Dr. Ghuman is with the University of Arizona, Tucson; Dr. Cunningham is with McMaster University, Hamilton, Ontario, Canada; Drs. McCracken and McGough are with the University of California, Los Angeles; Drs. Swanson, T. Wigal, and S. Wigal are with the University of California, Irvine; and Mr. Cooper is also with the Nathan Kline Institute, Orangeburg, NY; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD.
authors.forename: James
authors.initials: J
authors.lastname: Swanson
authors.affiliation: Dr. Greenhill and Posner, Mr. Davies, Mr. Cooper, Ms. Skrobala, and Ms. Chuang are with the New York State Psychiatric Institute/Columbia University; Dr. Kollins is with Duke University, Durham, NC; Dr. Abikoff is with the New York University Child Study Center, New York; Dr. Riddle is with Johns Hopkins University, Baltimore; Dr. Ghuman is with the University of Arizona, Tucson; Dr. Cunningham is with McMaster University, Hamilton, Ontario, Canada; Drs. McCracken and McGough are with the University of California, Los Angeles; Drs. Swanson, T. Wigal, and S. Wigal are with the University of California, Irvine; and Mr. Cooper is also with the Nathan Kline Institute, Orangeburg, NY; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD.
authors.forename: James
authors.initials: J
authors.lastname: McGough
authors.affiliation: Dr. Greenhill and Posner, Mr. Davies, Mr. Cooper, Ms. Skrobala, and Ms. Chuang are with the New York State Psychiatric Institute/Columbia University; Dr. Kollins is with Duke University, Durham, NC; Dr. Abikoff is with the New York University Child Study Center, New York; Dr. Riddle is with Johns Hopkins University, Baltimore; Dr. Ghuman is with the University of Arizona, Tucson; Dr. Cunningham is with McMaster University, Hamilton, Ontario, Canada; Drs. McCracken and McGough are with the University of California, Los Angeles; Drs. Swanson, T. Wigal, and S. Wigal are with the University of California, Irvine; and Mr. Cooper is also with the Nathan Kline Institute, Orangeburg, NY; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD.
authors.forename: Sharon
authors.initials: S
authors.lastname: Wigal
authors.affiliation: Dr. Greenhill and Posner, Mr. Davies, Mr. Cooper, Ms. Skrobala, and Ms. Chuang are with the New York State Psychiatric Institute/Columbia University; Dr. Kollins is with Duke University, Durham, NC; Dr. Abikoff is with the New York University Child Study Center, New York; Dr. Riddle is with Johns Hopkins University, Baltimore; Dr. Ghuman is with the University of Arizona, Tucson; Dr. Cunningham is with McMaster University, Hamilton, Ontario, Canada; Drs. McCracken and McGough are with the University of California, Los Angeles; Drs. Swanson, T. Wigal, and S. Wigal are with the University of California, Irvine; and Mr. Cooper is also with the Nathan Kline Institute, Orangeburg, NY; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD.
authors.forename: Tim
authors.initials: T
authors.lastname: Wigal
authors.affiliation: Dr. Greenhill and Posner, Mr. Davies, Mr. Cooper, Ms. Skrobala, and Ms. Chuang are with the New York State Psychiatric Institute/Columbia University; Dr. Kollins is with Duke University, Durham, NC; Dr. Abikoff is with the New York University Child Study Center, New York; Dr. Riddle is with Johns Hopkins University, Baltimore; Dr. Ghuman is with the University of Arizona, Tucson; Dr. Cunningham is with McMaster University, Hamilton, Ontario, Canada; Drs. McCracken and McGough are with the University of California, Los Angeles; Drs. Swanson, T. Wigal, and S. Wigal are with the University of California, Irvine; and Mr. Cooper is also with the Nathan Kline Institute, Orangeburg, NY; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD.
authors.forename: Benedetto
authors.initials: B
authors.lastname: Vitiello
authors.affiliation: Dr. Greenhill and Posner, Mr. Davies, Mr. Cooper, Ms. Skrobala, and Ms. Chuang are with the New York State Psychiatric Institute/Columbia University; Dr. Kollins is with Duke University, Durham, NC; Dr. Abikoff is with the New York University Child Study Center, New York; Dr. Riddle is with Johns Hopkins University, Baltimore; Dr. Ghuman is with the University of Arizona, Tucson; Dr. Cunningham is with McMaster University, Hamilton, Ontario, Canada; Drs. McCracken and McGough are with the University of California, Los Angeles; Drs. Swanson, T. Wigal, and S. Wigal are with the University of California, Irvine; and Mr. Cooper is also with the Nathan Kline Institute, Orangeburg, NY; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD.
authors.forename: Anne
authors.initials: A
authors.lastname: Skrobala
authors.affiliation: Dr. Greenhill and Posner, Mr. Davies, Mr. Cooper, Ms. Skrobala, and Ms. Chuang are with the New York State Psychiatric Institute/Columbia University; Dr. Kollins is with Duke University, Durham, NC; Dr. Abikoff is with the New York University Child Study Center, New York; Dr. Riddle is with Johns Hopkins University, Baltimore; Dr. Ghuman is with the University of Arizona, Tucson; Dr. Cunningham is with McMaster University, Hamilton, Ontario, Canada; Drs. McCracken and McGough are with the University of California, Los Angeles; Drs. Swanson, T. Wigal, and S. Wigal are with the University of California, Irvine; and Mr. Cooper is also with the Nathan Kline Institute, Orangeburg, NY; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD.
authors.forename: Kelly
authors.initials: K
authors.lastname: Posner
authors.affiliation: Dr. Greenhill and Posner, Mr. Davies, Mr. Cooper, Ms. Skrobala, and Ms. Chuang are with the New York State Psychiatric Institute/Columbia University; Dr. Kollins is with Duke University, Durham, NC; Dr. Abikoff is with the New York University Child Study Center, New York; Dr. Riddle is with Johns Hopkins University, Baltimore; Dr. Ghuman is with the University of Arizona, Tucson; Dr. Cunningham is with McMaster University, Hamilton, Ontario, Canada; Drs. McCracken and McGough are with the University of California, Los Angeles; Drs. Swanson, T. Wigal, and S. Wigal are with the University of California, Irvine; and Mr. Cooper is also with the Nathan Kline Institute, Orangeburg, NY; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD.
authors.forename: Jaswinder
authors.initials: J
authors.lastname: Ghuman
authors.affiliation: Dr. Greenhill and Posner, Mr. Davies, Mr. Cooper, Ms. Skrobala, and Ms. Chuang are with the New York State Psychiatric Institute/Columbia University; Dr. Kollins is with Duke University, Durham, NC; Dr. Abikoff is with the New York University Child Study Center, New York; Dr. Riddle is with Johns Hopkins University, Baltimore; Dr. Ghuman is with the University of Arizona, Tucson; Dr. Cunningham is with McMaster University, Hamilton, Ontario, Canada; Drs. McCracken and McGough are with the University of California, Los Angeles; Drs. Swanson, T. Wigal, and S. Wigal are with the University of California, Irvine; and Mr. Cooper is also with the Nathan Kline Institute, Orangeburg, NY; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD.
authors.forename: Charles
authors.initials: C
authors.lastname: Cunningham
authors.affiliation: Dr. Greenhill and Posner, Mr. Davies, Mr. Cooper, Ms. Skrobala, and Ms. Chuang are with the New York State Psychiatric Institute/Columbia University; Dr. Kollins is with Duke University, Durham, NC; Dr. Abikoff is with the New York University Child Study Center, New York; Dr. Riddle is with Johns Hopkins University, Baltimore; Dr. Ghuman is with the University of Arizona, Tucson; Dr. Cunningham is with McMaster University, Hamilton, Ontario, Canada; Drs. McCracken and McGough are with the University of California, Los Angeles; Drs. Swanson, T. Wigal, and S. Wigal are with the University of California, Irvine; and Mr. Cooper is also with the Nathan Kline Institute, Orangeburg, NY; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD.
authors.forename: Mark
authors.initials: M
authors.lastname: Davies
authors.affiliation: Dr. Greenhill and Posner, Mr. Davies, Mr. Cooper, Ms. Skrobala, and Ms. Chuang are with the New York State Psychiatric Institute/Columbia University; Dr. Kollins is with Duke University, Durham, NC; Dr. Abikoff is with the New York University Child Study Center, New York; Dr. Riddle is with Johns Hopkins University, Baltimore; Dr. Ghuman is with the University of Arizona, Tucson; Dr. Cunningham is with McMaster University, Hamilton, Ontario, Canada; Drs. McCracken and McGough are with the University of California, Los Angeles; Drs. Swanson, T. Wigal, and S. Wigal are with the University of California, Irvine; and Mr. Cooper is also with the Nathan Kline Institute, Orangeburg, NY; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD.
authors.forename: Shirley
authors.initials: S
authors.lastname: Chuang
authors.affiliation: Dr. Greenhill and Posner, Mr. Davies, Mr. Cooper, Ms. Skrobala, and Ms. Chuang are with the New York State Psychiatric Institute/Columbia University; Dr. Kollins is with Duke University, Durham, NC; Dr. Abikoff is with the New York University Child Study Center, New York; Dr. Riddle is with Johns Hopkins University, Baltimore; Dr. Ghuman is with the University of Arizona, Tucson; Dr. Cunningham is with McMaster University, Hamilton, Ontario, Canada; Drs. McCracken and McGough are with the University of California, Los Angeles; Drs. Swanson, T. Wigal, and S. Wigal are with the University of California, Irvine; and Mr. Cooper is also with the Nathan Kline Institute, Orangeburg, NY; Dr. Vitiello is with the National Institute of Mental Health, Bethesda, MD.
authors.forename: Tom
authors.initials: T
authors.lastname: Cooper
mesh_terms: D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000523:psychology; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use*; D002675:Child, Preschool; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000009:adverse effects / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome
chemical_list: D000697:Central Nervous System Stimulants; D008774:Methylphenidate