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

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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, ABIKOFF, HOWARD, KOLLINS, SCOTT, McCRACKEN, JAMES, RIDDLE, MARK, POSNER, KELLY, GHUMAN, JASWINDER, DAVIES, MARK, THORP, BEN, STEHLI, ANNAMARIE·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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Attention Deficit Hyperactivity Disorder in Preschool-Age Children
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“There were no significant differences in AE frequencies between dose conditions.(42) Three of 8 severe AEs met the FDA criteria for serious.”
Influential
α2-Adrenergic Agonists or Stimulants for Preschool-Age Children With Attention-Deficit/Hyperactivity Disorder
Harstad, E. B., Justine Shults, A., Barbaresi, W. J., Bax, A. C., Cacia, J., Deavenport‐Saman, A., Friedman, S., LaRosa, A., Loe, I. M., Mittal, S., et al. (2021) · JAMA · doi:10.1001/jama.2021.6118 · Cited by 43
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Stimulant Drug Effects on Attention Deficit/Hyperactivity Disorder: A Review of the Effects of Age and Sex of Patients
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Review of pharmacotherapy options for the treatment of attention‐deficit/hyperactivity disorder (ADHD) and ADHD‐like symptoms in children and adolescents with developmental disorders
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“Additionally, there is a higher rate of methylphenidate discontinuation due to adverse events for preschoolers than older children.(124) With atomoxetine, frequent adverse effects related to treatment were gastrointestinal issues, sleep disturbance, irritability, defiance, agitation, and crying/whining.”
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Risperidone and liver function tests in children and adolescents: A short-term prospective study
Erdoğan, A., Atasoy, N., Akkurt, H., Ozturk, D., Karaahmet, E., Yaluğ, İ., Yaluğ, K., Ankaralı, H. Ç., & Balcıoğlu, İ. C. (2008) · Progress in Neuro-Psychopharmacology and Biological Psychiatry · doi:10.1016/j.pnpbp.2007.12.032 · Cited by 38
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A Developmental Perspective on Attention-Deficit/Hyperactivity Disorder (ADHD)
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“Stimulant medication is often the first-line treatment for school-aged children with ADHD, and recent research indicates that stimulants are effective for preschoolers (Vitiello et al, 2007; Wigal et al., 2006).”
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“As illustrated in Table 3, ADHD medications have been associated with a range of common and rare adverse effects(46) that correlate with age/developmental stage.(22) While many adverse events are often transient and dose dependent,(47) effects such as appetite loss may persist for years.”
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“As opposed to older children, pharmacotherapy is not advised for children at this age (NICE, 2018; Taylor et al., 2004), as studies on pharmacotherapy in preschool children tend to show lower effects and more side effects (Greenhill et al., 2006; Swanson et al., 2006; Wigal et al., 2006).”
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Risperidone Versus Methylphenidate in Treatment of Preschool Children With Attention-Deficit Hyperactivity Disorder
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“This group also had higher rates of emotional adverse effects including lability, crabbiness, irritability, and proneness to crying compared to older children (4-11).”
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“…Burrows-Maclean et al., 2005; Pelham, Gnagy, et al., 1999; Pelham, Manos, et al., 2005; Pliszka et al., 2000) +1.7% (Pelham, Aronoff, et al., 1999; Wigal et al., 2006) — — -3.8% (Barkley et al., 1990; Daviss et al., 2008; Greenhill et al., 2002; Pelham, BurrowsMaclean et al., 2005; Pelham, Gnagy,…”
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“[26,27].”
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Leddy, J. J., Waxmonsky, J. G., Salis, R. J., Paluch, R. A., Gnagy, E. M., Mahaney, P., Erbe, R. W., Pelham, W. E., & Epstein, L. H. (2009) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2008.046 · Cited by 27
“Brain DA signaling is one of the determinants of the motivation to eat (Berridge 1996; Epstein and Leddy 2006), and there are dose-dependent effects of stimulants on appetite suppression and weight gain (Poulton 2005; Charach et al. 2006; Pliszka et al. 2006; Wigal et al. 2006).”
Prospective, Naturalistic, Pilot Study of Open-Label Atomoxetine Treatment in Preschool Children with Attention-Deficit/Hyperactivity Disorder
GHUMAN, J. K., Aman, M. G., Ghuman, H. S., Reichenbacher, T., Gelenberg, A. J., Wright, R., Rice, S. A., & Fort, C. L. (2009) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2008.054 · Cited by 27
“A discontinuation rate of 8.3% due to MPH side effects was reported (Wigal et al. 2006).”
Influential
The Open-Label Treatment of Attention-Deficit/Hyperactivity Disorder in 4- and 5-Year-Old Children with Beaded Methylphenidate
Maayan, L. A., Paykina, N., Fried, J., Strauss, T., Gugga, S. S., & Greenhill, L. L. (2008) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2008.053 · Cited by 27
“The prevalence of these adverse events was along the lines of that seen in the PATS study (Wigal et al. 2006) and greater than that seen in the MTA study, thus underscoring the relative vulnerability of younger children to adverse events.”
The impact of prescribed psychotropics on youth
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Long-Term Safety of Stimulant Medications Used to Treat Children with ADHD
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Changes in behavior as side effects in methylphenidate treatment: review of the literature
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The Effect of Water Treadmill Exercise on Children with Attention Deficit Hyperactivity Disorder
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Adverse reactions of Methylphenidate in children with attention deficit-hyperactivity disorder: Report from a referral center
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“Previous studies and reviews demonstrated sleep disturbances as a common adverse reaction of stimulants such as methylphenidate.[25,26] Based on polysomnography, various sleep abnormalities including delayed onset, shorter duration, and delayed rapid eye movement may be associated with methylphenidate.”
Result
Efficacy and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: sex and age effects and effect size across the day
Wigal, S. B., Kollins, S. H., Childress, A. C., & Adeyi, B. (2010) · Child and Adolescent Psychiatry and Mental Health · doi:10.1186/1753-2000-4-32 · Cited by 23
“In addition, the preschoolers in the PATS showed a higher rate of methylphenidate discontinuation due to spontaneously reported AEs than did school-aged children in the MTA study (ie, 11% vs <1%) [21].”
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Melatonin reduces neuronal loss and cytoskeletal deterioration: implications for Psychiatry
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Prediction of sleep side effects following methylphenidate treatment in ADHD youth
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“The efficacy of stimulant medications in treating ADHD in preschool-aged children has been more variable than seen in older children,(58) and reports of side effects are increased (eg, sadness, irritability, clinginess, insomnia, and anorexia).(47,59) The PATS study examined immediate-release methylphenidate in 3- to…”
Background
Psychotropic Medication Use in Children With Autism in the Kentucky Medicaid Population
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Attention Deficit/Hyperactivity Disorder in Preschool-Age Children: Issues and Concerns
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Background
Growth and Puberty in a 2-Year Open-Label Study of Lisdexamfetamine Dimesylate in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder
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Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Titration Study of Methylphenidate Hydrochloride Extended-Release Capsules (Aptensio XR) in Preschool Children with Attention-Deficit/Hyperactivity Disorder
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“In PATS, AEs that were statistically more frequent on MPH than placebo included decreased appetite, insomnia, and weight loss during dose titration (Wigal et al. 2006).”
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Promoting Parent Engagement in Behavioral Intervention for Young Children With ADHD: Iterative Treatment Development
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“…children indicated significant reduction in ADHD symptoms (Greenhill et al., 2006), the study also raised critical concerns regarding the use of medication with this age group, most notably the risk for adverse side effects including reduced growth rates (Swanson et al., 2006; Wigal et al., 2006).”
Background

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: GREENHILL, LAURENCE
McGOUGH, JAMES
VITIELLO, BENEDETTO
SWANSON, JAMES
ABIKOFF, HOWARD
KOLLINS, SCOTT
McCRACKEN, JAMES
RIDDLE, MARK
DAVIES, MARK
STEHLI, ANNAMARIE
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 (medical) › 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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Safety and Tolerability of Methylphenidate in Preschool Children With ADHD

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