Schulz 2010.

Methods	A multicentre, randomised, cross‐over trial with 2 interventions: Minimal breakfast Standard breakfast Phases: 2 phases of 1 week each. All participants were treated with Ritalin LA
Participants	Number of participants screened: 159 Number of participants included: 150 Number of participants followed up: 145 Number of withdrawals: 5 Diagnosis of ADHD: DSM‐IV (subtype: combined (67.3%), hyperactive‐impulsive (6%), inattentive (26.7%)) Age: mean 9.7 (SD 1.6) years old (range 6‐12) IQ: not stated, but patients not meeting minimum intelligence requirements were excluded Sex: 112 males, 38 females Methylphenidate‐naïve: 0% Ethnicity: white: 95.3%, African American: 1.3%, Asian: 2%, others: 1.3% Country: Germany Comorbidity: not clear, see exclusion criteria 1 Comedication: not clear, see exclusion criteria 8 Sociodemographics: not stated Inclusion criteria: Children aged 6‐12 years with a known diagnosis of ADHD according to DSM‐IV criteria On stable treatment with any methylphenidate medication for ≥ 1 month prior to screening Male and female patients aged 6‐12 Patients having a confirmed diagnosis of ADHD of any type according to DSM‐IV criteria, as established by history and adequate exploration Patients whose symptoms are adequately controlled by a stable and well‐tolerated dose of an immediate release‐ or extended release‐methylphenidate equivalent of 20 or 40 mg immediate release methylphenidate for 1 month before screening Patients with parents or a legal guardian, who will give written informed consent for the child to participate in the study. Additionally, consent to participate must be obtained from all children entering the study if the child is able to judge the nature, the meaning and the significance of the clinical trial (according to §40 para. 4 No. 4 AMG). Consent will be documented by the child's signature on the consent form Exclusion criteria: Major clinical psychiatric or somatic comorbidities Contraindications against methylphenidate treatment Patients with comorbid psychiatric conditions with symptoms requiring current pharmacological treatment (e.g. major depression, psychosis) Patients with comorbid psychiatric or somatic conditions that may contraindicate treatment or confound efficacy and safety assessments Patients with comorbid moderate to severe eating disorder (e.g. bulimia, anorexia nervosa, binge eating) Clinically significant diseases or significant abnormal findings during the initial exam in the opinion of the investigator Patients with a BMI outside the 10th and 90th age percentile Patients who are taking any concomitant medications likely to interfere with the study drug or to confound efficacy or safety assessments, e.g. Tricyclic antidepressants, buproprion, clonidine, buspirone 2 weeks before randomisation Atomoxetine 2 weeks before randomisation Fluoxetine or antipsychotics 1 month before randomisation Pemoline and amphetamines 1 week before randomisation
Interventions	Methylphenidate type: Ritalin LA (extended release) Mean methylphenidate dosage: 20 mg or 40 mg Administration schedule: not stated Duration of intervention: 14 days Treatment compliance: not stated
Outcomes	Serious adverse events: No deaths or serious adverse events occurred in the study Non‐serious adverse events: A total number of 36 patients (24%) experienced a total of 64 adverse events, 33 of which were considered to be related to study medication No mentioning of how the adverse events were measured
Notes	Sample calculation: no Ethics approval: yes, Central Ethics Committee University Freiburg Funding/vested interest: sponsored by Novartis Pharma GmbH, Germany Authors' affiliations: several authors have received funding from medical companies Key conclusions of the study authors: all of the clinical rating scales showed consistently no difference between the 2 breakfast conditions. The clinical efficacy of Ritalin LA is not influenced by breakfast and works independently of food intake Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: yes