Amiri 2008.

Methods	A 6‐week, parallel group, randomised controlled trial with 2 arms: Modafinil Methylphenidate
Participants	Number of patients screened: not stated Number included: 60 Number randomised to methylphenidate: 30 and (modafinil): 30 Number followed‐up: MPH: 27 Number of withdrawals: MPH: 3 Diagnosis of ADHD: DSM‐IV‐TR (subtype: combined (100%)) Age: mean 8.96 years old IQ: > 70 Sex: 24 males, 6 females Methylphenidate‐naïve: not stated Ethnicity: Persian Country: Iran Comorbidity: not stated Comedication: not stated Sociodemographics: not stated Inclusion criteria: Between the ages of 6‐15 DSM‐IV‐TR diagnostic criteria for ADHD Total and/or subscale scores on Attention‐Deficit/Hyperactivity DisorderRating Scale IV (ADHD‐RS‐IV) School Version ≥ 1.5 SD above norms for patient's age and gender Parents and children had to be willing to comply with all requirements of the study Exclusion criteria: History or current diagnosis of pervasive developmental disorders, schizophrenia or other psychiatric disorders (DSM‐IV axis I) Any current psychiatric comorbidity that required pharmacotherapy Any evidence of suicide risk or mental retardation (IQ < 70 based on clinical judgement) A clinically significant chronic medical condition, including organic brain disorder, seizures and, current abuse or dependence on drugs within 6 months Hypertension, hypotension and habitual consumption of more than 250 mg/day of caffeine
Interventions	Participants were randomly assigned to methylphenidate or modafinil Metylphenidate type: not stated Methylphenidate dosage: 20‐30 mg/day depending on weight (20 mg/day for < 30 kg and 30 mg/day for > 30 kg) Administration schedule: not stated Duration of intervention: 6 weeks Titration period: 3 weeks, initiated after randomisation Treatment compliance: not stated
Outcomes	Side effect checklist (20 side effects) administered by a child psychiatrist on days 7, 21 and 42 Haematology tests, baseline and weeks 2, 4 and 6 serum chemistry and urinalysis, baseline and week 6 Body weight and vital signs, baseline and weeks 1, 2, 4, and 6 12‐lead ECG and physical examinations, baseline and week 6 Non‐serious adverse events: Abdominal pain, anxiety/nervousness, decreased appetite, sadness, difficulty falling asleep, weight loss, nausea, dry mouth, irritability, headaches
Notes	Sample calculation: yes Ethics approval: yes Funding/vested interest: this study was supported by a grant (grant number: 3317) from Tehran University of Medical Sciences Authors' affiliations: no affiliations to pharmaceutical companies stated Key conclusions of the study authors: no significant differences were observed between the 2 groups (modafinil vs methylphenidate) on the Parent and Teacher Rating Scale scores. Side effects of decreased appetite and difficulty falling asleep were observed more in the methylphenidate group. The results of this study indicate that modafinil significantly improved symptoms of ADHD and was well tolerated and it is beneficial in the treatment of children with ADHD Comments from the study authors: the limitations of the present study, including lack of a placebo group, using only ADHD Rating Scale for measuring outcome and the small number of participants should be considered so further research in this area is needed Comments from the review authors: checklist with 20 possible side effects administered, but only the 10 observed side effects are reported Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: no Supplemental adverse event data has not been possible to receive through personal email correspondence with the authors in June‐August 2013