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

Columbia University, New York, New York, United States
Journal of the American Academy of Child & Adolescent Psychiatry (Impact Factor: 7.26). 11/2006; 45(11):1284-93. DOI: 10.1097/01.chi.0000235077.32661.61
Source: PubMed


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).
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.
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.
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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Available from: Kelly Posner, Dec 27, 2013
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    • "While stimulant medication is relatively easy to implement and often provides rapid therapeutic benefit, a significant minority of youth with ADHD do not respond to stimulant medication (10–30 %; Goldman et al. 1998) or experience significant side effects that prohibit continued use (\10 %; Graham and Coghill 2008). Additionally, stimulant medications appear less effective for young children with ADHD (Greenhill et al. 2006) and may result in an increased rate of side effects (Wigal et al. 2006). Parental perceptions of stimulant medication's impact on overall health and preference for alternative (non-medication) treatments also limit the use of and compliance with stimulant medication (Chacko et al. 2010)—by some accounts, up to 58 % of parents refuse stimulant medication for their child with ADHD (Krain et al. 2005). "
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