Laurence Greenhill1, Scott Kollins2, Howard Abikoff2, James McCracken2, Mark Riddle2, James Swanson2, James McGough2, Sharon Wigal2, Tim Wigal2, Benedetto Vitiello2, Anne Skrobala2, Kelly Posner2, Jaswinder Ghuman2, Charles Cunningham2, Mark Davies2, Shirley Chuang2, Tom Cooper2. 1. 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. 2. 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.
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). METHOD: 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 setfor 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.
RCT Entities:
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). METHOD: 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.
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Authors: Mark A Riddle; Kseniya Yershova; Deborah Lazzaretto; Natalya Paykina; Gayane Yenokyan; Laurence Greenhill; Howard Abikoff; Benedetto Vitiello; Tim Wigal; James T McCracken; Scott H Kollins; Desiree W Murray; Sharon Wigal; Elizabeth Kastelic; James J McGough; Susan dosReis; Audrey Bauzó-Rosario; Annamarie Stehli; Kelly Posner Journal: J Am Acad Child Adolesc Psychiatry Date: 2013-02-08 Impact factor: 8.829
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