Yildiz 2011.
Methods | A 14‐week parallel, randomised, open‐label trial (first 2 weeks screening phase) with 2 arms:
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Participants | Number of participants screened: not stated Number of participants included: 12 Number of participants followed up: 11 Number of withdrawals: 1 Diagnsosis of ADHD: DSM‐IV‐TR (subtype: combined (66.7%), inattentive ( 33.3%)). Age: mean 10.16, range 8‐14 years old IQ: none with mental retardation Sex: not stated Methylphenidate‐naïve: not stated Ethnicity: not stated Country: Turkey Comorbidity: oppositional defiant disorder: 7, learning disorder: 6 Comedication: participants taking concomitant psychoactive medications were excluded from the study Sociodemographics: not stated Inclusion criteria
Exclusion criteria
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Interventions | Methylphenidate type: osmotic release oral system (OROS) Mean methylphenidate dosage: 1.07 mg/kg/day Administration schedule: morning dose, once daily Duration of intervention: 12 weeks Treatment compliance: not stated |
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Outcomes |
Non‐serious adverse events: Weight, height, pulse, systolic, diastolic blood pressure, AST, ALT, EEG, ECG, observer, beginning and end point (12 weeks) Self‐reported medication related adverse events 18 item list, parent/children, at 4, 8 and 12 weeks 1 child discontinued the study due to chest pain and palpitations |
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Notes | Sample calculation: no Ethics approval: approved by the Local Independent Ethics Committee Funding/vested interests: not stated Authors' affiliations: Department of Child and Adolescent Psychiatry, Kocaeli University, Izmit, Turkey Key conclusions of the study authors: treatment responses were not significantly different between the 2 study groups. OROS‐methylphenidate led to a significantly greater reduction in teacher T‐DSM‐IV‐S scores. OROS‐methylphenidate was more effective than atomoxetine on Stoop‐5 time and number of corrections. Significant decrease in the percentage of perseverative errors on WCST in the OROS‐methylphenidate group was seen. In the OROS‐methylphenidate group, patients most frequently reported anorexia, nervousness, insomnia, headache, nausea and weight loss. When all the results are considered, although both drugs can be considered effective in ADHD treatment, more remarkable improvement is provided by OROS‐methylphenidate based on the rates across informant and neuropsychological evaluation |