Ghanizadeh 2013.
Methods | An 8‐week parallel trial with 2 arms:
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Participants | Number of patients screened: not stated Number included: 49 Number randomised to methylphenidate + placebo: 26 Number randomised to methylphenidate + folic acid: 23 Number followed up in methylphenidate + placebo: 13 Number of withdrawals in methylphenidate + placebo: 13 Methylphenidate + placebo group Diagnosis of ADHD: DSM‐IV (subtype: not stated) Age: mean 9.9, range 5‐16 years old IQ: no estimated mental retardation Sex: 23 males, 3 females Methylphenidate‐naïve: not stated Ethnicity: not stated Country: Iran Comorbidity: not stated Comedication: not stated Sociodemographics: not stated Inclusion criteria
Exclusion criteria
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Interventions | Methylphenidate type: not stated Mean MPH dosage: 10 mg/day (< 25 kg) and 20 mg/day (> 24 kg) Administration schedule: twice daily Duration of intervention: 2 months Treatment compliance: not stated |
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Outcomes |
Non‐serious adverse events: Self‐reported measures upon dropout from study |
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Notes | Sample calculation: yes Ethics approval: approved by the Shiraz University of Medical Sciences Ethics Committee Funding/vested interests/authors' affiliations: not stated Key conclusions of the study authors: considering the marked limitations of this trial, this report suggests that methylphenidate may improve ADHD symptoms and the quality of life of children with ADHD. Current evidence does not support that folic acid as an adjuvant is effective for treating ADHD symptoms or aggression, or improving quality of life of children with ADHD Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: no |