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

The DOI matches its Crossref record; 26 of the 26 references it cites were found in a registry or an index.

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

Open this paper in CoChat — free account

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.

Integrity signals

Registry

Crossref · 10.1097/01.chi.0000235082.63156.27

Cites

26 of 26 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Nelson Textbook of Pediatrics
(1976) · The Medical Journal of Australia · doi:10.5694/j.1326-5377.1976.tb115280.x · Cited by 5,225
A 14-Month Randomized Clinical Trial of Treatment Strategies for Attention-Deficit/Hyperactivity Disorder
(1999) · Archives of General Psychiatry · doi:10.1001/archpsyc.56.12.1073 · Cited by 3,372
Nelson Textbook of Pediatrics
Sissman, N. J. (2000) · JAMA · doi:10.1001/jama.284.3.369 · Cited by 862
Side Effects of Metlyiphenidate in Children With Attention Deficit Hyperactivity Disorder: A Systemic, Placebo-Controlled Evaluation
Barkley, R. A., McMurray, M. B., EDELBROCK, C. S., & Robbins, K. (1990) · PEDIATRICS · doi:10.1542/peds.86.2.184 · Cited by 481
Efficacy and safety of immediate-release methylphenidate treatment for preschoolers with ADHD
GREENHILL, L., KOLLINS, S., ABIKOFF, H., MCCRACKEN, J., RIDDLE, M., SWANSON, J., MCGOUGH, J., WIGAL, S., WIGAL, T., VITIELLO, B., et al. (2006) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1097/01.chi.0000235077.32661.61 · Cited by 467
Side effects of methylphenidate in children with attention deficit hyperactivity disorder: a systemic, placebo-controlled evaluation.
Barkley, R. A., McMurray, M. B., EDELBROCK, C. S., & Robbins, K. (1990) · PubMed · Cited by 433
Medication treatment strategies in the MTA Study: relevance to clinicians and researchers
GREENHILL, L. L., ABIKOFF, H. B., ARNOLD, L. E., CANTWELL, D. P., CONNERS, C. K., ELLIOTT, G., HECHTMAN, L., HINSHAW, S. P., HOZA, B., JENSEN, P. S., et al. (1996) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1097/00004583-199610000-00017 · Cited by 297
Hyperactivity in preschoolers and the effect of methylphenidate.
Schleifer, M., Weiss, G., Cohen, N. J., Elman, M., Cvejic, H., & Kruger, E. (1975) · American Journal of Orthopsychiatry · doi:10.1111/j.1939-0025.1975.tb01164.x · Cited by 234
Nelson textbook of pediatrics, 16th ed.
Behrman, R. E. (2000) · Cited by 219
Pharmacotherapy for Children with Attention-Deficit Hyperactivity Disorder
Pelham, W. E. (1993) · School Psychology Review · doi:10.1080/02796015.1993.12085647 · Cited by 207

Show all 25 references

Research works printed but not linked: 1

Greenhill, 2001, Preschool ADHD Treatment Study (PATS): science and controversy, Economics Neurosci, 3, 49

Sorted by citations

Items 101–200 of 242

Pharmacologic Intervention for Attention-Deficit Hyperactivity Disorder in Preschoolers: Is It Justified?
Ghuman, J. K., & Ghuman, H. S. (2013) · Pediatric Drugs · doi:10.1007/s40272-012-0001-5 · Cited by 21
“Preschoolers had a high rate (30 %) of adverse events and a unique adverse effect profile, including more irritability and mood changes, compared with school-age children treated with methylphenidate, as well as similar adverse effects as school-age children, including reduced appetite, difficulty falling asleep, and…”
Background
Safety of stimulant treatment in attention deficit hyperactivity disorder: part II
Merkel, R. L. (2010) · Expert Opinion on Drug Safety · doi:10.1517/14740338.2010.503238 · Cited by 21
“2 Cardiovascular and hypertension Many studies have shown no difference with regard to vital sign changes among placebo and MPH [21,44], MPH MR [104], mixed amphetamine salts extended release (MAS Merkel”
BackgroundResult
Stimulant Treatment of Young People in the United States
Olfson, M., King, M. D., & Schoenbaum, M. (2016) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2015.0228 · Cited by 21
“Because of uncertainty over the efficacy, tolerability, and longterm safety of stimulants in preschool children (Greenhill et al. 2006; Wigal et al. 2006) and evidence supporting the effectiveness of behavioral interventions (Sonuga-Barke et al.”
Background
Drug Class Review on Pharmacologic Treatments for ADHD
McDonagh, M. S., Peterson, K., & Thakurta, S. (2005) · Cited by 21
Comparison of Parent Education and Functional Assessment-Based Intervention Across 24 Months for Young Children With Attention Deficit Hyperactivity Disorder
DuPaul, G. J., Kern, L., Volpe, R. J., Caskie, G. I. L., Sokol, N. G., Arbolino, L. A., Brakle, J. V., & Pipan, M. E. (2013) · School Psychology Review · doi:10.1080/02796015.2013.12087491 · Cited by 21
“…in ADHD symptoms; however, a higher percentage of young children relative to elementary school-age children experienced significant adverse events (Greenhill et al., 2006; Vitiello et al., 2007; Wigal et al., 2006), including reduction growth rates for height and weight (Swanson et al., 2006).”
Background
Safety of stimulant treatment in attention deficit hyperactivity disorder: part I
Merkel, R. L., & Kuchibhatla, A. (2009) · Expert Opinion on Drug Safety · doi:10.1517/14740330903279956 · Cited by 20
“Although most studies of stimulant treatment of ADHD are short-term studies, there are a few longer term follow-up studies that show that the stimulants continued to be well tolerated [7,27].”
BackgroundInfluential
Long-Term Safety of Stimulant Medications Used to Treat Children with ADHD
Lerner, M., & Wigal, T. L. (2008) · Journal of Psychosocial Nursing and Mental Health Services · doi:10.3928/02793695-20080801-06 · Cited by 20
Pharmacotherapy for Preschool Children with Attention Deficit Hyperactivity Disorder (ADHD): Current Status and Future Directions
Young, J. R., Yanagihara, A., Dew, R., & Kollins, S. (2021) · CNS Drugs · doi:10.1007/s40263-021-00806-z · Cited by 13
“Patients received cyproheptadine 4 mg for each Table 3 Adverse effects of psychostimulants in preschool children with ADHD [38, 39]”
BackgroundMethod
The relationship between physical fitness and inhibitory ability in children with attention deficit hyperactivity disorder: An event-related potential study
Tsai, Y.-J., Hung, C., Tsai, C., Chang, Y., Huang, C., & Hung, T. (2016) · Psychology of sport and exercise · doi:10.1016/j.psychsport.2016.05.006 · Cited by 20
“Although drug treatment for ADHD is effective, side effects often reduce its overall effectiveness (Wigal et al., 2006) and thus making it important to explore supplementary or alternative treatments for this disorder.”
Background
Methylphenidate dose–response in children with ADHD: evidence from a double-blind, randomized placebo-controlled titration trial
Vertessen, K., Luman, M., Swanson, J. M., Bottelier, M. A., Stoffelsen, R., Bet, P. M., Wisse, A., Twisk, J. W. R., & Oosterlaan, J. (2023) · European Child & Adolescent Psychiatry · doi:10.1007/s00787-023-02176-x · Cited by 20
“Side effects were reported using an adapted version of the MTA Side Effect Rating Scale [19], using a scoring system according to Wigal [32].”
Method
Changes and Challenges: Managing ADHD in a Fast-Paced World
Manos, M. J., Tom-Revzon, C., Bukstein, O. G., & Crismon, M. L. (2007) · Journal of Managed Care Pharmacy · doi:10.18553/jmcp.2007.13.9-b.1 · Cited by 18
Practice Parameter for the Assessment and Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder
assessment, I. A. M. H., (inattention, T. C. S. S. F. A. B. S. A. Q. R. T. M. S. D. O. A., impulsivity, the, A. H. A. A. W. S. S. C. I. T. S. Q. S. B. A. R. O. T. N. O. T. C. C. R. S. O. S. Q. C., symptoms of ADHD can also be included in clinic/office registration materials to be completed by parents before visits or in the waiting room before the evaluation. If a parent reports that the patient suffers from any symptoms of ADHD that induce impairment or if the patient scores in the clinical range for ADHD symptoms on a rating scale, & indicated., T. A. F. E. F. A. A. S. O. I. T. N. R. I. (2008) · FOCUS The Journal of Lifelong Learning in Psychiatry · doi:10.1176/foc.6.3.foc401 · Cited by 18
Relationships between food-related behaviors, obesity, and medication use in individuals with Smith-Magenis syndrome
Gandhi, A., Wilson, T. A., Sisley, S. R., Elsea, S. H., & Foster, R. H. (2022) · Research in Developmental Disabilities · doi:10.1016/j.ridd.2022.104257 · Cited by 16
Long-Term Treatment of ADHD With Stimulants
Powell, S. G., Thomsen, P. H., Frydenberg, M., & Rasmussen, H. (2010) · Journal of Attention Disorders · doi:10.1177/1087054710368486 · Cited by 18
“, 2006; Pliszka & AACAP Work Group on Quality Issues, 2007) and may in part be due to a greater proneness to side effects in this group, which demands cautious titration (Pliszka & AACAP Work Group on Quality Issues, 2007; Wigal et al., 2006).”
BackgroundInfluential
Escitalopram Treatment in Preschool Children with Anxiety Disorders: A Case Series
Coşkun, M., Öztürk, M., & Zoroglu, S. S. (2012) · Klinik Psikofarmakoloji Bülteni-Bulletin of Clinical Psychopharmacology · doi:10.5455/bcp.20120729101822 · Cited by 16
“Regarding psychopharmacological treatment in preschool children, more prominent data come from several studies on the efficacy and safety of methylphenidate in preschool children with attention-deficit hyperactivity disorder (4-6) and risperidone in preschool children with autism spectrum disorders (7,8) or disruptive…”
Influential
Adverse Events in Very Young Children Prescribed Psychotropic Medications: Preliminary Findings from an Acute Clinical Sample
Lee, C. S., Williamson, L. R., Martin, S. E., DeMarco, M., Majczak, M., Martini, J., Hunter, H. L., Fritz, G. K., & Boekamp, J. R. (2015) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2015.0034 · Cited by 18
“Of notable exception are the Preschool ADHD Treatment Study (PATS) (Wigal et al. 2006), which examines the effectiveness, safety, and tolerability of methylphenidate in preschool-age children, and the Pediatric OCD Treatment Study (POTS) (Pediatric OCD Treatment Study Team 2004) and the Pediatric…”
Influential
Safety of Stimulants Across Patient Populations
Oliva, H. N. P., Prudente, T. P., Mayerson, T. F., Mignosa, M. M., Oliva, I. O., Potenza, M. N., Jegede, O. O., & Angarita, G. A. (2025) · JAMA Network Open · doi:10.1001/jamanetworkopen.2025.9492 · Cited by 23
Revisiting stimulant use for emotional dysregulation in attention-deficit/hyperactivity disorder (ADHD)
Brancati, G. E., Acierno, D., Barbuti, M., Elefante, C., Gemignani, S., Raia, A., & Perugi, G. (2023) · Expert Review of Neurotherapeutics · doi:10.1080/14737175.2023.2263645 · Cited by 16
“This latter finding is consistent with the relatively high rates of treatment-emergent and treatment-limiting emotional lability and irritability observed in trials of MPH and LDX in preschoo-lers [69–71].”
Result
Efficacy of stimulants for preschool attention‐deficit/hyperactivity disorder: A systematic review and meta‐analysis
Sugaya, L. S., Farhat, L. C., Califano, P., & Polanczyk, G. V. (2023) · JCPP Advances · doi:10.1002/jcv2.12146 · Cited by 16
Treatment of Attention-Deficit/Hyperactivity Disorder in Preschool-Age Children: Child and Adolescent Psychiatrists' Adherence to Clinical Practice Guidelines
Chung, J., Tchaconas, A., Meryash, D. L., & ADESMAN, A. R. (2016) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2015.0108 · Cited by 17
“The bases for this guideline is the demonstrated efﬁcacy of behavior therapy in reducing ADHD behaviors (Pelham et al. 1998; Greenhill et al. 2003) and the greater potential for side effects of medication in this age group (Wigal et al. 2006).”
Beyond the ‘typical’ patient: Treating attention-deficit/hyperactivity disorder in preschoolers and adults
Vaughan, B. S., Wetzel, M. W., & Kratochvil, C. J. (2008) · International Review of Psychiatry · doi:10.1080/09540260801887751 · Cited by 15
“Twenty-one children (11%) discontinued due to adverse events, although no drug related serious adverse events were reported (Wigal et al., 2006).”
Background
Effect of methylphenidate and folic Acid on ADHD symptoms and quality of life and aggression: a randomized double blind placebo controlled clinical trial.
Ghanizadeh, A. J., Sayyari, Z., & Mohammadi, M. R. (2013) · Europe PMC (PubMed Central) · Cited by 14
Enhancing attention in children using an integrated cognitive-physical videogame: A pilot study
Anguera, J. A., Rowe, M. A., Volponi, J. J., Elkurdi, M., Jurigova, B. G., Simon, A. J., Anguera‐Singla, R., Gallen, C. L., Gazzaley, A. H., & Marco, E. J. (2023) · npj Digital Medicine · doi:10.1038/s41746-023-00812-z · Cited by 18
“The most common and research tested effective intervention for ADHD, stimulant medication, can lead to headaches 2 , insomnia 3 – 5 , nausea 6,7 , emotional outbursts 8,9 , and in some children, psychosis 10,11 .”
Neurotrophin 3 genotype and emotional adverse effects of osmotic-release oral system methylphenidate (OROS-MPH) in children with attention-deficit/hyperactivity disorder
Park, S., Kim, B.-N., Kim, J.-W., Shin, M., Cho, S.-C., Kim, J.-H., Son, J.-W., Shin, Y., Chung, U., & Han, D. H. (2013) · Journal of Psychopharmacology · doi:10.1177/0269881113480989 · Cited by 13
“There is also some evidence for increased levels of emotionality, social withdrawal, nausea, and stomach ache (Graham and Coghill, 2008; Wigal et al., 2006).”
Background
Long-Term Treatment With Extended-Release Methylphenidate Treatment in Children Aged 4 to <6 Years
Childress, A. C., Foehl, H. C., Newcorn, J. H., Faraone, S. V., Levinson, B., & Adjei, A. L. (2021) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1016/j.jaac.2021.03.019 · Cited by 15
Six Months of Treatment with Risperidone May Be Associated with Nonsignificant Abnormalities of Liver Function Tests in Children and Adolescents: A Longitudinal, Observational Study from Turkey
Erdoğan, A., Karaman, M. G., Özdemir, E., Yurteri, N., Tufan, A. E., & Kurçer, M. A. (2010) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2009.0113 · Cited by 13
“Prescription of antidepressant agents may increase the susceptibility to hepatic trouble (Wigal et al. 2006; Schatzberg 2007; Findling et al. 2004).”
New Findings from the Preschoolers with Attention-Deficit/Hyperactivity Disorder Treatment Study (PATS)
Riddle, M. A. (2007) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2007.17501 · Cited by 12
Methylphenidate–risperidone combination in child psychiatry: A retrospective analysis of 44 cases
Javelot, H., Glay-Ribau, C., Ligier, F., Weiner, L., Didelot, N., Messaoudi, M., Socha, M., Lawson, F. B., & Kabuth, B. (2014) · Annales Pharmaceutiques Françaises · doi:10.1016/j.pharma.2013.12.009 · Cited by 13
Treatment of Attention-Deficit/Hyperactivity Disorder
Pierce, K. (2011) · Pediatric Annals · doi:10.3928/00904481-20111007-06 · Cited by 11
Lisdexamfetamine Dimesylate for Preschool Children with Attention-Deficit/Hyperactivity Disorder
Childress, A. C., Findling, R. L., Wu, J. X., Kollins, S. H., Wang, Y., Martin, P. T., & Robertson, B. (2020) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2019.0117 · Cited by 11
“Across the PATS, adverse events (AEs) were reported more frequently with MPH than placebo and the most commonly reported AEs occurring with MPH versus placebo included emotional outbursts, difficulty falling asleep, and decreased appetite (Wigal et al. 2006).”
BackgroundResultInfluential
Psychopharmaka im Kindes- und Jugendalter
Trott, G. (2008) · Springer eBooks · doi:10.1007/978-3-540-68748-1_57 · Cited by 11
Medicaid Prior Authorization Policies for Medication Treatment of Attention-Deficit/Hyperactivity Disorder in Young Children, United States, 2015
Hulkower, R. L., Kelley, M., Cloud, L. K., & Visser, S. N. (2017) · Public Health Reports · doi:10.1177/0033354917735548 · Cited by 10
“Research on the use of ADHD medications among preschoolers shows that young children who take ADHD medications are significantly more likely than older children who take ADHD medications to experience negative health side effects from the medications, including emotional lability, appetite loss, trouble sleeping, stom…”
Background
Alcance y limitaciones del tratamiento farmacológico del Trastorno por Déficit de Atención e Hiperactividad en niños y adolescentes y Guías de Práctica Clínica: una revisión bibliográfica
Eizaguirre, M. Á. V., & Aróstegui, J. A. I. (2014) · Revista de la Asociación Española de Neuropsiquiatría · doi:10.4321/s0211-57352014000100004 · Cited by 14
The Impact of a Motor-Cognitive Remediation Program on Attentional Functions of Preschoolers With ADHD Symptoms
Chevalier, N., Parent, V., Rouillard, M., Simard, F., Guay, M., & Verret, C. (2012) · Journal of Attention Disorders · doi:10.1177/1087054712468485 · Cited by 11
“There are controversies, however, with pharmacological interventions for ADHD with preschoolers because of a lack of evidence for effectiveness (Greenhill et al., 2006), concerns about side effects (Wigal et al., 2006), and ethical consents (Perring, 1997).”
Background
Growing evidence of pharmacotherapy effectiveness in managing attention-deficit/hyperactivity disorder in young children with or without autism spectrum disorder: a minireview
Alsayouf, H. A. (2024) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2024.1408876 · Cited by 9
Association of Coexisting Conditions, Attention-Deficit/Hyperactivity Disorder Medication Choice, and Likelihood of Improvement in Preschool-Age Children: A Developmental Behavioral Pediatrics Research Network Study
Deavenport‐Saman, A., Vanderbilt, D. L., Harstad, E. B., Justine Shults, A., Barbaresi, W. J., Bax, A. C., Cacia, J., Friedman, S., LaRosa, A., Loe, I. M., et al. (2022) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2022.0009 · Cited by 9
“The most rigorous assessment of stimulant medication for ADHD in young children was the Preschool ADHD Treatment Study (PATS), a six-site randomized clinical trial of methylphenidate in 3-to 5.5-year-old children with ADHD (Greenhill et al. 2006; Wigal et al. 2006; Ghuman et al. 2007).”
Influential
Pharmacotherapy of ADHD in young children.
Vaughan, B. S., & Kratochvil, C. J. (2006) · PubMed Central · Cited by 9
Comparison of brief group behavioural parent training with individual parent training for preschool children with attention deficit hyperactivity disorder: A randomized feasibility study
Vaidyanathan, S., Chandrasekaran, V., & Kandasamy, P. (2023) · Early Intervention in Psychiatry · doi:10.1111/eip.13420 · Cited by 8
“Off-label use of stimulants, clonidine, atomoxetine, and other drugs are prevalent practices in this age group despite the risk of side effects (Connor et al., 1999; Ghuman et al., 2009; Vaidyanathan et al., 2020; Wigal et al., 2006).”
Background
Acute Tolerability of Methylphenidate in Treatment-Naïve Children with ADHD: An Analysis of Naturalistically Collected Data from Clinical Practice
Masi, G., Pfanner, C., Liboni, F., Lenzi, F., Villafranca, A., D’Acunto, G., Fantozzi, P., Falcone, F., Simonelli, V., Muratori, P., et al. (2022) · Pediatric Drugs · doi:10.1007/s40272-022-00492-4 · Cited by 8
“Higher rates of intolerable adverse events have been reported in children with ADHD in the context of autism spectrum disorder (ASD) [8%] and in preschoolers with ADHD (6%), mostly due to emotional outbursts and irritability [7, 8].”
Background
The Preschool ADHD Treatment Study (PATS) as the Culmination of Twenty Years of Clinical Trials in Pediatric Psychopharmacology
March, J. S. (2011) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1016/j.jaac.2010.09.018 · Cited by 8
Response to methylphenidate by adult and pediatric patients with attention-deficit/hyperactivity disorder: the Spanish multicenter DIHANA study
Valdizán-Usón (2013) · Neuropsychiatric Disease and Treatment · doi:10.2147/ndt.s35836 · Cited by 8
“Previous studies and reviews report insomnia, reduced appetite, abdominal pain, weight loss, tics, jitteriness, and headaches as the most common adverse effects of stimulant treatment, and, less frequently, anxiety, dizziness, and drowsiness, 44–46 but these are usually tolerable.”
The psychiatry of children aged 0–4: advances in assessment, diagnosis and treatment
Foreman, D. M. (2015) · BJPsych Advances · doi:10.1192/apt.bp.114.014100 · Cited by 8
Methylphenidate for children and adolescents with attention deficit hyperactivity disorder (ADHD)
Storebø, O. J., Storm, M. R. O., Ribeiro, J. P., Skoog, M., Groth, C., Edemann-Callesen, H., Schaug, J. P., Darling, P. J., Huus, C.-M. L., Zwi, M., et al. (2025) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd009885.pub4 · Cited by 10
Drug Class Review: Pharmacologic Treatments for Attention Deficit Hyperactivity Disorder
McDonagh, M. S., & Peterson, K. (2011) · Cited by 7
Early postnatal exposure to methylphenidate alters stress reactivity and increases hippocampal ectopic granule cells in adult rats
Torres-Reverón, A., Gray, J. D., Melton, J. T., Punsoni, M., Tabori, N. E., Ward, M. J., Frys, K. A., Iadecola, C., & Milner, T. A. (2008) · Brain Research Bulletin · doi:10.1016/j.brainresbull.2008.11.009 · Cited by 7
Treatment strategies for ADHD in preschool and school-age children
Sonnack, M., & Brenneman, A. (2014) · JAAPA · doi:10.1097/01.jaa.0000453859.08958.31 · Cited by 7
Adverse Effects of α-2 Adrenergic Agonists and Stimulants in Preschool-age Attention-deficit/Hyperactivity Disorder: A Developmental–Behavioral Pediatrics Research Network Study
Loe, I. M., Blum, N. J., Justine Shults, A., Barbaresi, W. J., Bax, A. C., Cacia, J., Deavenport‐Saman, A., Friedman, S., LaRosa, A., Mittal, S., et al. (2023) · The Journal of Pediatrics · doi:10.1016/j.jpeds.2023.01.004 · Cited by 7
Stimulant medication in pre‐school children in New South Wales
Eysbouts, Y. K., Poulton, A. S., & Salmelainen, P. (2011) · Journal of Paediatrics and Child Health · doi:10.1111/j.1440-1754.2011.02107.x · Cited by 7
Clinically Relevant Changes in Emotional Expression in Children With ADHD Treated With Lisdexamfetamine Dimesylate
Katic, A., Ginsberg, L., Jain, R., Adeyi, B., Dirks, B., Babcock, T., Scheckner, B., Richards, C., Lasser, R., Turgay, A., et al. (2012) · Journal of Attention Disorders · doi:10.1177/1087054710389990 · Cited by 10
Methylphenidate Transdermal System in Preschool Children with Attention-Deficit/Hyperactivity Disorder
GHUMAN, J. K., Byreddy, S., & Ghuman, H. S. (2011) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2011.0049 · Cited by 6
“Preschoolers are known to have high rates of adverse events (AEs) with stimulant treatment (Wigal et al. 2006; Ghuman et al. 2008, 2009).”
ADHS im Vorschulalter
Zenglein, Y., Beyer, A., Freitag, C. M., & Schwenck, C. (2013) · Kindheit und Entwicklung · doi:10.1026/0942-5403/a000117 · Cited by 6
Effects of Folic Acid on Appetite in Children with Attention Deficit Hyperactivity Disorder (ADHD) Treated with Methylphenidate: A Randomized Double-Blind Clinical Trial.
Riahi, F., Tashakori, A., & Vanani, G. S. (2018) · Europe PMC (PubMed Central) · Cited by 6
Long-term Safety of Stimulant Medications Used to Treat Children with ADHD
Lerner, M., & Wigal, T. L. (2008) · Psychiatric Annals · doi:10.3928/00485713-20080101-10 · Cited by 6
Update on Screening, Referring, and Treating the Behavioral, Social, and Mental Health Problems of Very Young Children
Bekman, S., John‐Larkin, C. S., Paul, J. J., Millar, A. M., & Frankel, K. A. (2017) · Current Treatment Options in Pediatrics · doi:10.1007/s40746-017-0076-x · Cited by 6
Influence of Age, Gender, and Living Circumstances on Patterns of Attention-Deficit/Hyperactivity Disorder Medication Use in Children and Adolescents With or Without Intellectual Disabilities
Osunsanmi, S., & Turk, J. (2016) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2014.0139 · Cited by 6
“…intellectual disability and ADHD (5–11.99 years) might reﬂect clinician reluctance to prescribe stimulant medications for children with intellectual disability because of concerns relating to reports of higher side effect proﬁles in them (Aman et al. 1993; Handen et al. 1999; Wigal et al. 2006).”
Influential
Attention‐Deficit Hyperactivity Disorder
Rube, D. M., & Kaur, T. (2012) · Wiley eBooks · doi:10.1002/9781119962229.ch10 · Cited by 6
Comparison between the efficacies of Risperidone with Haloperidol in the treatment of attention-deficit hyperactivity disorder (ADHD) among preschoolers: a randomized double-blind clinical trial
Riahi, F., Tashakori, A., & Abdi, L. (2016) · Electronic physician · doi:10.19082/2840 · Cited by 5
“Only Dextroamphetamine and Adderall have been approved by the FDA for children aged 3 to 6 years; although in this age group, when the children are treated with stimulants, they will experience more side effects (8).”
BackgroundInfluential
A Comparative Study of Risperidone and Aripiprazole in Attention Deficit Hyperactivity Disorder in Children Under Six Years Old: A Randomized Double-Blind Study
Razjouyan, K., Danesh, A., Khademi, M., Davari-Ashtiani, R., & Noorbakhsh, S. (2018) · Iranian Journal of Pediatrics · doi:10.5812/ijp.60087 · Cited by 5
“Mostly characterized by symptoms like hyperactivity, inattention and impulsivity (1), attention deficit hyperactivity disorder (ADHD) is one of the most common neurobehavioral disorders in childhood (2).”
Background
Pre-school attention deficit hyperactivity disorder: 12 weeks prospective study
Vaidyanathan, S., Rajan, T. M., Chandrasekaran, V., & Kandasamy, P. (2019) · Asian Journal of Psychiatry · doi:10.1016/j.ajp.2019.101903 · Cited by 5
ADHD
Graham, J. S., Seth, S., & Coghill, D. (2007) · Medicine · doi:10.1016/j.mpmed.2007.01.002 · Cited by 5
Stimulant Treatment and Potential Adverse Outcomes in Pediatric Populations With Bipolar Disorder: A Systematic Review of the Literature
O’Connor, H., Vater, C. H., DiSalvo, M., Faraone, S. V., & Wozniak, J. R. (2023) · Journal of Attention Disorders · doi:10.1177/10870547231218045 · Cited by 5
“In a treat-ment study examining the safety and tolerability of MPH, 30% of parents reported moderate to severe adverse events with irritability as the most common adverse event (Wigal et al., 2006).”
BackgroundResultInfluential
Treatment of Preschool ADHD: Overview of the Preschool ADHD Treatment Study (PATS)
Lubberstedt, B., Vaughan, B. S., & Kratochvil, C. J. (2007) · Child and Adolescent Psychopharmacology News · doi:10.1521/capn.2007.12.3.1 · Cited by 5
Psychostimulants
Pliszka, S. R. (2012) · Wiley eBooks · doi:10.1002/9781119958338.ch6 · Cited by 5
Effect of vigorous-intensity exercise on the working memory and inhibitory control among children with attention deficit hyperactivity disorder: a systematic review and meta-analysis
Zhang, R., & Li, H. (2025) · The Italian Journal of Pediatrics/Italian journal of pediatrics · doi:10.1186/s13052-025-01924-w · Cited by 9
“The side effects of stimulant medication are unacceptable to some families [10], specifically when involving young children [11].”
Principles in using psychotropic medications in children and adolescents
Vitiello, B. (2012) · Institutional Research Information System University of Turin (University of Turin) · Cited by 4
Comparison of Medication Treatments for Preschool Children With ADHD
Froehlich, T. E. (2021) · JAMA · doi:10.1001/jama.2021.5603 · Cited by 4
ADHD psychopharmacology across the lifespan
Vitiello, B. (2009) · Current Attention Disorders Reports · doi:10.1007/s12618-009-0010-7 · Cited by 4
“Eleven percent of the PATS preschoolers discontinued treatment because of adverse effects such as decreased appetite, weight loss, sleep diffi culties, irritability, and repetitive behaviors or thoughts [ 11 ].”
Background
Finding the Tools for Effective Early Intervention for Preschool Attention-Deficit/Hyperactivity Disorder
Gleason, M. M. (2013) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1016/j.jaac.2012.12.008 · Cited by 6
Psychopharmacologic Considerations in Early Childhood
Finelli, J. M., & Gleason, M. M. (2019) · Springer eBooks · doi:10.1007/978-3-030-10635-5_9 · Cited by 3
A multidimensional approach to medication selection in the treatment of children and adolescents with ADHD.
Turgay, A. (2007) · PubMed Central · Cited by 3
Recent NIMH Clinical Trials and Implications for Practice
Kratochvil, C. J., & Vitiello, B. (2008) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1097/chi.0b013e31818960a7 · Cited by 3
The Case against Stimulants
Jackson, G. E. (2009) · doi:10.1007/978-1-137-02058-1_10 · Cited by 3
Individual Participant Data Meta-Analysis: Moderators of Response to Stimulants for Preschool Attention-Deficit/Hyperactivity Disorder
Farhat, L. C., Sugaya, L. S., Bloch, M. H., Childress, A. C., Cortese, S., Fatori, D., Salum, G. A., Rohde, L. A., & Polanczyk, G. V. (2025) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1016/j.jaac.2025.09.012 · Cited by 2
Traumaassoziierte Störungen, ADHS, externalisierende und Zwangsstörungen
Bindt, C., Möhler, E., & von Gontard, A. (2026) · Zeitschrift für Kinder- und Jugendpsychiatrie und Psychotherapie · doi:10.1024/1422-4917/a001090 · Cited by 2
A Paradigm Shift in Intervention Approaches for Children with Attention-Deficits/ Hyperactivity Disorders: A Systematic Review of Psycho-Behavioral Interventions
Tsang, K. L. V. 曾. (2016) · Acta Psychopathologica · doi:10.4172/2469-6676.100044 · Cited by 3
“Despite the significant intervention effects found in stimulant medication, parents chose not to use stimulant medication because of its notable side-effects [15-17].”
Background
Aufmerksamkeitsdefizit- und Hyperaktivitätsstörungen (ADHS)/Hyperkinetische Störungen (HKS)
Rank, S. M. (2019) · Springer eBooks · doi:10.1007/978-3-658-27810-6_15 · Cited by 2
Iranian Traditional Medicine for Treatment of Attention Deficit Disorder with Hyperactivity in Children: A Systematic Review of Randomized Controlled Trials
Noorazar, S. G., Mirzaei, M., & Kalejahi, P. (2024) · Iranian Journal of Public Health · doi:10.18502/ijph.v53i2.14913 · Cited by 2
Peer Functioning in Children with AD/HD: A Review of Current Understanding and Intervention Options
Özdemir, S. (2009) · Current Issues in Education · Cited by 2
Cognitive Development Considerations for Long-term Safety Exposures in Children
Pipan, M. E., Wang, P. P., & Penna, R. T. (2013) · Wiley eBooks · doi:10.1002/9781118312087.ch30 · Cited by 2
Intervention for Young Children With, and At–Risk for, ADHD
Kern, L., & DuPaul, G. J. (2008) · The ADHD Report · doi:10.1521/adhd.2008.16.1.6 · Cited by 2
Le Trouble Déficitaire de l’Attention avec Hyperactivité (TDAH) au préscolaire : nature, évaluation et traitement
Leblanc, N. (2010) · Santé mentale au Québec · doi:10.7202/039132ar · Cited by 2
“…du TDAH après les 70 semaines de traitement (Greenhill et al., 2006), 2) 11 % des enfants ont cessé le traitement pharmacologique en raison d’effets secondaires intolérables (Wigal et al., 2006) et 3) sur le plan de la croissance physique des enfants, une diminution de la taille (d’environ 20”
Background
When Preschool Children Have ADHD
Stein, M. T. (2007) · Journal watch · doi:10.1056/pa200701100000001 · Cited by 2
Effect of a 12-week interval running program on female primary school students with ADHD
Bahram, M. E., Assarian, F., Atoof, F., Taghadosi, M., Akkasheh, N., & Akasheh, G. (2014) · KAUMS Journal · Cited by 2
Safety of Psychotropic Drugs in Children and Adolescents
Kaguelidou, F., & Acquaviva, É. (2015) · Springer eBooks · doi:10.1007/978-3-319-24741-0_13 · Cited by 2
Constructing a Joint Clinical Case Formulation and Treatment Plan with Families
Tamkin, V. L., Dave, B., Whittaker, A. T. N., & Frankel, K. A. (2019) · Springer eBooks · doi:10.1007/978-3-030-10635-5_10 · Cited by 2
Psychiatric Illness, Psychotropic Medication, and Childhood Obesity
Maayan, L. A., & Citrome, L. (2010) · Elsevier eBooks · doi:10.1016/b978-0-12-374995-6.10025-8 · Cited by 2
Psychopharmacology in Preschool Children
Tandon, M., & Luby, J. L. (2012) · doi:10.1002/9781119958338.ch16 · Cited by 2
Therapeutic Use of Dopamine Enhancers (Stimulants)
Zuddas, A., & Carucci, S. (2023) · Springer eBooks · doi:10.1007/978-3-030-42825-9_138-1 · Cited by 1
An Open Randomized Controlled Trial Comparing Group and Individual Parent-Child Interaction Therapy for Preschoolers with Attention-Deficit/hyperactivity Disorder
Eyberg, S. M., Nelson, M. M., Guzick, A. G., Druskin, L. R., McNeil, C. B., & Bussing, R. (2025) · Evidence-Based Practice in Child and Adolescent Mental Health · doi:10.1080/23794925.2025.2457147 · Cited by 1
“…by caregivers and youth (Charach et al., 2014; Coletti et al., 2012), while also serving as an approach that mitigates concerning side-effects of stimulant medication use (e.g., sleep difficulties, appetite suppression) shown in samples of children within this age range (Wigal et al., 2006).”
ADHD and Methylphenidate Use in Prepubertal Children and BMI and Height at Adulthood
Song, J., Park, S. J., Yu, J., Chung, J., Jeong, S., & Park, S. M. (2026) · JAMA Network Open · doi:10.1001/jamanetworkopen.2025.52019 · Cited by 1
Face-To-Face Vs. Online Behavioral Parent Training for Young Children with ADHD: Child and Parent Outcomes
DuPaul, G. J., Kern, L., Dever, B. V., Ariol, M., Morse, S. T., Chunta, A. M., Rosenthal, E., Ahn, J. H., Chen, R., Franklin‐Gillette, S., et al. (2026) · Journal of Clinical Child & Adolescent Psychology · doi:10.1080/15374416.2026.2687069 · Cited by 1
“A randomized controlled trial (RCT) of stimulant medication in a large sample of preschool-aged children indicated significant reduction in ADHD symptoms (Greenhill et al., 2006); however, medication was associated with heightened risk for adverse side effects (Wigal et al., 2006).”
Interaction between Weight and Medications in Psychological Illnesses of Children
Apter, A. S., & Steingart, L. (2013) · World review of nutrition and dietetics · doi:10.1159/000342531 · Cited by 1
Pharmacogenomics of Attention-Deficit/Hyperactivity Disorder
Froehlich, T. E., & Stein, M. A. (2010) · Advances in biological psychiatry · doi:10.1159/000317300 · Cited by 1
Pharmacological treatment of attention-deficit hyperactivity disorder in preschool-age children requires care
Writers, A. M. (2013) · Drugs & Therapy Perspectives · doi:10.1007/s40267-013-0053-9 · Cited by 1
“%) of adverse events occurred in the preschoolers who received methylphenidate in PATS [6, 19].”
Influential
Central nervous system stimulants and drugs that suppress appetite
Sequeira, R. P. (2009) · Side effects of drugs annual · doi:10.1016/s0378-6080(09)03101-8 · Cited by 1
Treatment of Attention-Deficit/Hyperactivity Disorder with Medication in Children with Autism Spectrum Disorder With and Without Intellectual Disability: A DBPNet Study
Grater, J. E., Muñiz, E. I., Silver, E. J., Blum, N. J., Justine Shults, A., & Stein, R. E. K. (2022) · Journal of Autism and Developmental Disorders · doi:10.1007/s10803-022-05611-1 · Cited by 1
“This could be because studies show greater side effects of methylphenidate in younger children than in school aged children (Greenhill et al., 2006; Wigal et al., 2006).”
Background
Advances in preschool psychopharmacology
Luby, J. L., & Riddle, M. A. (2009) · Mary Ann Liebert eBooks · Cited by 1
FPIN's clinical inquiries: Management of ADHD in preschool-aged children.
Klein, S., Ho, V., Tazkarji, B., & Auten, B. (2013) · PubMed · Cited by 1
Adverse effects of stimulant medications in children and adolescents: focus on drug abuse
Greydanus, D. E., Cates, K. W., & Sadigh, N. (2019) · International Journal of Adolescent Medicine and Health · doi:10.1515/ijamh-2019-0175 · Cited by 1
Pharmacological treatment and prognosis of ADHD
Elia, J., Kingsley, R. S., Lam, C., Takeda, T., de Berardinis, R., Laracy, S. D., Sackett, J. C., Tang, S.-C., Schardt, M., Nivus, K., et al. (2013) · doi:10.2217/ebo.13.229 · Cited by 1

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

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review

Safety and Tolerability of Methylphenidate in Preschool Children With ADHD

Abstract

Overview

Integrity signals

Verification

Claims the paper makes

Claims other papers make about this one

Citations

Cites

Cited by

Related

Metadata

Record

About these checks