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J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1284-1293. doi: 10.1097/01.chi.0000235077.32661.61.

Efficacy and safety of immediate-release methylphenidate treatment for preschoolers with ADHD.

Author information

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.

Erratum in

  • J Am Acad Child Adolesc Psychiatry. 2007 Jan;46(1):141.

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 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.

[Indexed for MEDLINE]

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