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Randomized Controlled Trial
. 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

Affiliations
Randomized Controlled Trial

Efficacy and Safety of Immediate-Release Methylphenidate Treatment for Preschoolers With ADHD

Laurence Greenhill et al. J Am Acad Child Adolesc Psychiatry. .

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.

Comment in

  • Stimulant-related reductions of growth rates in the PATS.
    Swanson J, Greenhill L, Wigal T, Kollins S, Stehli A, Davies M, Chuang S, Vitiello B, Skrobala A, Posner K, Abikoff H, Oatis M, McCRACKEN J, McGOUGH J, Riddle M, Ghuman J, Cunningham C, Wigal S. Swanson J, et al. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1304-1313. doi: 10.1097/01.chi.0000235075.25038.5a. J Am Acad Child Adolesc Psychiatry. 2006. PMID: 17023868 Clinical Trial.
  • Rationale, design, and methods of the Preschool ADHD Treatment Study (PATS).
    Kollins S, Greenhill L, Swanson J, Wigal S, Abikoff H, McCRACKEN J, Riddle M, McGOUGH J, Vitiello B, Wigal T, Skrobala A, Posner K, Ghuman J, Davies M, Cunningham C, Bauzo A. Kollins S, et al. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1275-1283. doi: 10.1097/01.chi.0000235074.86919.dc. J Am Acad Child Adolesc Psychiatry. 2006. PMID: 17023869 Clinical Trial.
  • Pharmacogenetics of methylphenidate response in preschoolers with ADHD.
    McGOUGH J, McCRACKEN J, Swanson J, Riddle M, Kollins S, Greenhill L, Abikoff H, Davies M, Chuang S, Wigal T, Wigal S, Posner K, Skrobala A, Kastelic E, Ghuman J, Cunningham C, Shigawa S, Moyzis R, Vitiello B. McGOUGH J, et al. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1314-1322. doi: 10.1097/01.chi.0000235083.40285.08. J Am Acad Child Adolesc Psychiatry. 2006. PMID: 17023870 Clinical Trial.
  • Safety and tolerability of methylphenidate in preschool children with ADHD.
    Wigal T, Greenhill L, Chuang S, McGOUGH J, Vitiello B, Skrobala A, Swanson J, Wigal S, Abikoff H, Kollins S, McCRACKEN J, Riddle M, Posner K, Ghuman J, Davies M, Thorp B, Stehli A. Wigal T, et al. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1294-1303. doi: 10.1097/01.chi.0000235082.63156.27. J Am Acad Child Adolesc Psychiatry. 2006. PMID: 17028508 Clinical Trial.
  • Methylphenidate may improve symptoms but does not increase response compared with placebo in preschool children with ADHD.
    Wolraich ML. Wolraich ML. Evid Based Ment Health. 2007 May;10(2):60. doi: 10.1136/ebmh.10.2.60. Evid Based Ment Health. 2007. PMID: 17459991 No abstract available.

Comment on

  • Stimulant-related reductions of growth rates in the PATS.
    Swanson J, Greenhill L, Wigal T, Kollins S, Stehli A, Davies M, Chuang S, Vitiello B, Skrobala A, Posner K, Abikoff H, Oatis M, McCRACKEN J, McGOUGH J, Riddle M, Ghuman J, Cunningham C, Wigal S. Swanson J, et al. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1304-1313. doi: 10.1097/01.chi.0000235075.25038.5a. J Am Acad Child Adolesc Psychiatry. 2006. PMID: 17023868 Clinical Trial.
  • Rationale, design, and methods of the Preschool ADHD Treatment Study (PATS).
    Kollins S, Greenhill L, Swanson J, Wigal S, Abikoff H, McCRACKEN J, Riddle M, McGOUGH J, Vitiello B, Wigal T, Skrobala A, Posner K, Ghuman J, Davies M, Cunningham C, Bauzo A. Kollins S, et al. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1275-1283. doi: 10.1097/01.chi.0000235074.86919.dc. J Am Acad Child Adolesc Psychiatry. 2006. PMID: 17023869 Clinical Trial.
  • Pharmacogenetics of methylphenidate response in preschoolers with ADHD.
    McGOUGH J, McCRACKEN J, Swanson J, Riddle M, Kollins S, Greenhill L, Abikoff H, Davies M, Chuang S, Wigal T, Wigal S, Posner K, Skrobala A, Kastelic E, Ghuman J, Cunningham C, Shigawa S, Moyzis R, Vitiello B. McGOUGH J, et al. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1314-1322. doi: 10.1097/01.chi.0000235083.40285.08. J Am Acad Child Adolesc Psychiatry. 2006. PMID: 17023870 Clinical Trial.
  • Safety and tolerability of methylphenidate in preschool children with ADHD.
    Wigal T, Greenhill L, Chuang S, McGOUGH J, Vitiello B, Skrobala A, Swanson J, Wigal S, Abikoff H, Kollins S, McCRACKEN J, Riddle M, Posner K, Ghuman J, Davies M, Thorp B, Stehli A. Wigal T, et al. J Am Acad Child Adolesc Psychiatry. 2006 Nov;45(11):1294-1303. doi: 10.1097/01.chi.0000235082.63156.27. J Am Acad Child Adolesc Psychiatry. 2006. PMID: 17028508 Clinical Trial.

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