Çetin 2015.
Methods | A randomised, open‐label parallel study of methylphenidate or atomoxetine use for 6 months | |
Participants | Number of participants screened: not stated Number of participants included: 145 Number of participants randomised to methylphenidate: 73 Number of participants followed up on methylphenidate: 61 Number of withdrawals: 12 Diagnosis of ADHD: DSM‐IV‐TR (subtype: combined (91.8%), inattentive (8.2%)) Age mean: 9.47 (SD 2.32) years old IQ: above 90 Sex: 9 males (86.9%), 8 females (13.1%) Methylphenidate‐naïve: 100% Ethnicity: not stated Country: Turkey Comorbidity: none Comedication: not stated Sociodemographics: not stated Inclusion criteria:
Exclusion criteria:
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Interventions | Methylphenidate type: osmotic release oral system Mean methylphenidate dosage: 0.73 (SD 0.22) mg/kg/day Administration schedule: not stated Duration of intervention: 6 months Treatment compliance: not stated |
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Outcomes | The adverse effects and tolerability of medications were evaluated using a questionnaire including 12 questions about anorexia, insomnia, stomachache, nervousness, headache, weight loss, rash, obsessions, sedation, epistaxis, tics and others, in addition to open ended questions The rate of adverse effects observed was 31.1% (n = 19) in the OROS‐methylphenidate group Treatment was stopped in 5 patients because of the adverse effects Non‐serious adverse events:
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Notes | Sample calculation: not stated Ethics approval: yes, the study protocol was approved by local Ethics Committee Funding/vested interests/authors' affiliations: not stated Key conclusions of the study authors: OROS‐methylphenidate and atomoxetine had similar efficacies and adverse effect profiles in the treatment of ADHD Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: all participants were methylphenidate‐naïve |