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Cited by 242Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesPharmacology and Obesity Treatment

Safety and tolerability of methylphenidate in preschool children with ADHD

WIGAL, TIM, GREENHILL, LAURENCE, CHUANG, SHIRLEY, McGOUGH, JAMES, VITIELLO, BENEDETTO, SKROBALA, ANNE, SWANSON, JAMES, WIGAL, SHARON +9 more·2006·Journal of the American Academy of Child & Adolescent Psychiatry
DOI 10.1097/01.chi.0000235082.63156.27
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Abstract

Objective To report on the safety and tolerability of methylphenidate (MPH) 3- to 5-year-old children with attention-deficit/hyperactivity disorder (ADHD) during 1 year of treatment.Method Exactly 183 children (3-5 years old) entered a treatment study of MPH, consisting of a 1-week open-label lead-in (n=183); a 5-week placebo-controlled, double-blind phase (n=165); a 5-week double-blind, parallel phase (n=114); and 10 months of open-label maintenance (n=140 entered, 95 completed). Mean total daily MPH doses rose from the titration trial best dose, 14.1 (+/-8.1) mg/day, to 20.5 (+/-9.7) mg/day mean total daily dose at the end of maintenance. Pulse, blood pressure, and the presence of treatment emergent adverse events (AEs), parent and teacher AE ratings, and vital signs were recorded in each phase.Results Thirty percent of parents spontaneously reported moderate to severe AEs in all study phases after baseline. These included emotional outbursts, difficulty falling asleep, repetitive behaviors/thoughts, appetite decrease, and irritability. During titration, decreased appetite (chi=5.4, p<.03), trouble sleeping (chi=5.4, p<.03), and weight loss (chi=4.0, p<.05) occurred statistically more often on MPH than on placebo. During maintenance, trouble sleeping and appetite loss persisted and other MPH-related AEs decreased. There were transient, one-time pulse and blood pressure elevations in five children. Twenty-one children (11%) discontinued because of drug-attributed AEs.Conclusions Eleven percent of preschoolers discontinued treatment because of intolerable MPH AEs. Of the serious AEs reported, one occurred in baseline, two in lead-in, three in titration, one in parallel, and one in maintenance. Only one was possibly related to MPH.

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Authors
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.
Affiliations
University of Arizona (US)
Corresponding author
GREENHILL, LAURENCE
ORCID
Venue
Journal of the American Academy of Child & Adolescent Psychiatry
Publisher
Elsevier BV
Published
2006-11
Volume
45
Issue
11
Pages
1294-1303
ISSN
0890-8567 (ISSN-L)
DOI
10.1097/01.chi.0000235082.63156.27
OpenAlex
W2046668977
Cited by
242
References
25
Citations by year
2026: 5 · 2025: 7 · 2024: 4 · 2023: 13 · 2022: 6 · 2021: 7 · 2020: 6 · 2019: 9 · 2018: 8 · 2017: 7 · 2016: 14 · 2015: 10 · 2014: 14 · 2013: 15 · 2012: 16
FWCI
13.41
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Journal of the American Academy of Child & Adolescent Psychiatry (publishedVersion)
  • PubMed (publishedVersion)
  • Institutional Research Information System University of Turin (University of Turin) (submittedVersion)
Funders
National Institute of Mental Health (U01 MH 60943, U01 MH60900, K23MH001883, U01MH060903, U01 MH60833, U01MH060900, U01MH060848, U01MH060642, U01 MH 60642, U01 MH60903, U01MH060833, U01MH060943, U01 MH60848)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
  • Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
Keywords
methylphenidate, attention deficit hyperactivity disorder, preschool children, drug safety, tolerability, adverse events, sleep disorders, appetite loss, weight loss, treatment discontinuation, blood pressure, pulse rate
MeSH terms
Central Nervous System Stimulants, Anorexia, Attention Deficit Disorder with Hyperactivity, Child, Preschool, Double-Blind Method, Female, Humans, Male, Methylphenidate, Sleep Wake Disorders

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