Schulz 2010.
Methods | A multicentre, randomised, cross‐over trial with 2 interventions:
Phases: 2 phases of 1 week each. All participants were treated with Ritalin LA |
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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:
Exclusion criteria:
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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 |
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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 |
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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 |