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. 2018 May 10;2018(5):CD012069. doi: 10.1002/14651858.CD012069.pub2

Yildiz 2011.

Methods A 14‐week parallel, randomised, open‐label trial (first 2 weeks screening phase) with 2 arms:
  1. Atomoxetine

  2. Osmotic release oral system (OROS) methylphenidate

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
  1. Met diagnostic criteria for ADHD as defined by DSM‐IV‐TR

  2. Symptom severity at entry ≥ 4 points or above as assessed by the CGI‐S


Exclusion criteria
  1. Seizures, bipolar disorder, psychotic illness, mental retardation, pervasive developmental disorder

  2. Taking concomitant psychoactive medications

  3. Anxiety and tic disorders

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
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
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