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

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:
  1. Diagnosis of ADHD

  2. 7‐16 years old


Exclusion criteria:
  1. IQ > 90

  2. Presence of a central nervous system disease

  3. Organic problems

  4. Comorbid psychopathologies

  5. Previous treatment with the diagnosis of ADHD

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
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:
  1. Allergic reactions: 2

  2. Loss of appetite and weight loss > 10%: 2

  3. Tachycardia: 1

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