Mohammadi 2012a.

Methods	An 8‐week double‐blind parallel‐group randomised controlled trial with 2 arms: Methylphenidate + placebo Methylphenidate + melatonin
Participants	Number of participants screened: not stated Number of participants included: 60 Number randomised to methylphenidate + placebo: 32 and methylphenidate + melatonin: 28 Number followed up in the methylphenidate + placebo group: 24 Number of withdrawals in the methylphenidate + placebo group: 8 Methylphenidate + placebo group Diagnosis of ADHD: ICD‐10 (subtype: combined (100%)) Age: mean 8.83 years old (range 7‐12) IQ: above 70 Sex: 17 males, 7 females Methylphenidate‐naïve: 100% were newly diagnosed Ethnicity: not stated Country: Iran Comorbidity: no Comedication: no Sociodemographics: level of family income: low (58.8%), average (23.6%), high (17.6%) Inclusion criteria: 7‐12 years old Newly diagnosed with ADHD, ICD‐10 combined type Clinical need to be treated with methylphenidate Parental and child consent Exclusion criteria: Use of any confounding drugs or dietary supplements History of major prenatal complications such as prematurity Low birthweight (reported by parents) Any past or present psychosis, comorbid Tourette syndrome, celiac, phenylketonuria, autism, or other persistent developmental disorders Narcotics use Any confounding comorbidities
Interventions	Methylphenidate type: Ritalin Methylphenidate dosage: 1 mg/kg Administration schedule: not stated Duration of intervention: 8 weeks Treatment compliance: not stated
Outcomes	Sleep Disturbance Scale for Children (SDSC) sleep questionnaires and appetite questionnaires were completed by mothers at baseline, week 2, 4, and 8 Height, weight were measured by a dietitian at baseline and week 8. Weight was measured with minimal clothing and height without shoes in standard position 3‐day food records were completed by mothers at baseline and week 8 Stimulant drug side effects questionnaires were completed by mothers at week 8 (methylphenidate + placebo, n = 18)
Notes	Sample calculation: not stated Any withdrawals due to adverse events: not stated Ethics approval: yes Funding/vested interests: the study was financially supported by Research Deputy of Tehran University of Medical Sciences Authors' affiliations: not stated Key conclusions of study authors: melatonin with methylphenidate can partially improve symptoms of sleep disturbance by circadian cycle modification. However, it did not seem to reduce the attention deficiency and hyperactivity behaviour of ADHD children Exclusion of methylphenidate non‐responders/children who have previously experienced adverse events on methylphenidate: no Supplemental data received through personal email correspondence with the authors in July 2013 (Mohammadi 2013 [pers comm])