EUCTR2007‐004664‐46‐NL.

Study name	Public title: not reported Scientific title: Influence of methylphenidate on sleep and circadian rhythm in children with attention‐deficit/hyperactivity disorder (ADHD)
Methods	Double‐blind, randomised controlled, parallel‐group trial Study duration: 14 months
Participants	Sample size (target): 140 Inclusion criteria Aged 6‐12 years Recently diagnosed ADHD Indication for starting with MPH treatment Exclusion criteria: IQ < 80 Treatment with stimulants, melatonin, clonidine, risperidone, benzodiazepines Prior treatment with melatonin (> 0.1 mg) Contraindications for using MP Tourette’s syndrome, depression; anxiety disorder, pervasive developmental disorder or psychosis
Interventions	MPH 10 mg‐30 mg Placebo
Outcomes	Non‐serious AEs Sleep latency. Timing of outcome assessment not reported Sleep onset time. Timing of outcome assessment not reported Total time asleep (from actigraphy). Timing of outcome assessment not reported Difficulty falling asleep (from sleep log) and dim light melatonin onset from salivary melatonin Timing of outcome assessment not reported
Starting date	29 July 2008 (date of registration). Starting date not reported
Contact information	Not reported
Notes	Sponsor: no sponsor Declaration of interests: not reported