Yildiz 2010.
Methods | An 8‐week, open‐label, prospective, parallel study with 2 arms:
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Participants | Number of participants screened: not stated Number of participants included: 90 Number of participants randomised: OROS‐MPH: 50 and IR‐MPH: 40 Number of participants followed up: OROS‐MPH: 47 and IR‐MPH: 36 Number of withdrawals: OROS‐MPH: 3 and IR‐MPH: 4 Diagnosis of ADHD: DSM‐IV (subtype: combined (IR‐MPH: 75.0%, OROS‐MPH: 80.9%), inattentive (IR‐MPH: 25.0%, OROS‐MPH: 19.1%)) Age: mean 9.7 SD 1.8, range 7‐15 years old (IR‐MPH: 9.3 SD 1.3 and OROS‐MPH: 10.0 SD 2.1) IQ: above 80. WISC‐R total IQ: IR‐MPH: 99.9 SD 14.2 and OROS‐MPH: 99.5 SD 10.9 Sex: IR‐MPH: 28 males, 8 females. OROS‐MPH: 41 males, 6 females Methylphenidate‐naïve: not stated Ethnicity: not stated Country: Turkey Comorbidity: specific learning difficulties (IR‐MPH: 22.2%, OROS‐MPH: 23.4%) Comedication: not stated Sociodemographics: not stated Inclusion criteria
Exclusion criteria
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Interventions | Dosage the first 4 weeks: IR‐MPH: 10 mg/day. OROS‐MPH: 18 mg/day After the fourth week: IR‐MPH: 10 mg/day (n = 16) or 20 mg/day (n = 20) and OROS‐MPH: 18 mg/day (n = 22) or 36 mg/day (n = 25) Duration of intervention: 60 days Treatment compliance: not stated |
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Outcomes |
Non‐serious adverse events: Based on Side Effects of Stimulant Medications for Screening Scale developed by Turgay, there are 16 side effects for psychostimulants. Parents filled out the form for each side effects based on a 4‐point Likert scale (0: none, 1: rare, 2: moderate, 3: severe) in 4th and 8th week |
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Notes | Sample calculation: not stated Ethics approval: yes Funding/vested interests: not stated Key conclusions of the study authors: OROS‐methylphenidate was found to be as effective as IR‐methylphenidate in the treatment of behavioural symptoms in Turkish children with ADHD. These results demonstrated that both drugs were effective and well tolerated in the treatment of Turkish children with ADHD Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: yes |