Maayan 2009.

Methods	A cohort study of long‐acting methylphenidate use for 4 weeks
Participants	Number of participants screened: not stated Number of participants included: 11 Number of participants followed up: 8 Number of withdrawals: 3 Diagnosis of ADHD: DSM‐IV‐TR (subtype: combined (91%), hyperactive‐impulsive (9%)) Age: mean 5.1, range: 4‐5 years old IQ: above 70 Sex: 9 males, 2 females Methylphenidate‐naïve: 100% Ethnicity: white 27%, Hispanic 73% Country: USA Comorbidity: ODD 9% Comedication: none Sociodemographics: not stated Inclusion criteria Symptomatic for ≥ 9 months Parents and children had to speak English or Spanish Only children who were enrolled in an educational setting with ≥ 8 same‐age peers for at least 2 half days per week were eligible for the study. Participants had to have a CGI‐S score of ≥ 4 (moderately mentally ill) and a C‐GAS score ≥ 55. The Kaufman Brief Intelligence Test (K‐BIT) was administered to confirm an intelligence quotient (IQ) ≥70 Exclusion criteria History of intolerance or non‐response to stimulants Current adjustment disorders, autism, psychosis, bipolar disorder, or suicidality Children with a history of significant physical, sexual, or emotional abuse and medical abnormalities that would make use of B‐MPH clinically inappropriate were also excluded. Concomitant treatments with antihypertensives, medication affecting blood pressure or heart rate, sedating antihistamines, antiseizure medications, diphenhydramine, and/or other psychotropic agents were not allowed during the study
Interventions	Methylphenidate type: long acting Methylphenidate dosage: 10‐30 mg/day, mean 17.73 mg/day Administration schedule: morning Duration of intervention: 4 weeks Treatment compliance: not stated
Outcomes	Non‐serious adverse events Decreased appetite was experienced by 7 participants (64%) following treatment initiation. 5 out of these 7 participants continued to report decreased appetite for the duration of the study Difficulty sleeping occurred in 3 participants (27%) Emotional lability and gastrointestinal pain were reported by 2 participants (18%) These adverse events were resolved by the end of the study. 1 participant who terminated the study early experienced moderate levels of insomnia, vomiting, decreased appetite, and stomach pain, and another who also terminated early experienced moderate irritability
Notes	Sample calculation: no Ethics approval: the study was approved by the New York State Psychiatric Institute Columbia University Institutional Review Board (IRB) and was conducted in accordance with the ethical standards of the 1975 Declarations of Helsinki as revised in 2000 (World Medical Association). Funding/vested interests/authors' affiliations: Novartis Pharmaceuticals Corporation provided the study medication. No financial support was received from Novartis. Dr Maayan receives grant support from Eli Lilly and Pfizer. Dr Greenhill received support from Novartis and has an consultant arrangement with Pfizer. He has been awarded research contract to study Risperidon by Johnson and Johnson and has been awarded an investigator‐initiated grant to study aripiprazole by Otsuka Key conclusions of the study authors: long‐acting methylphenidate was safe and effective for the treatment of ADHD in the 4‐ and 5‐year‐olds participating in this study. Rates of adverse events were higher than previously reported in methylphenidate trials of school‐aged children. 10‐mg/day doses failed to achieve response in the 5 children who could not tolerate higher doses Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: yes