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Modafinil improves symptoms of ADHD compared with placebo in young people

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 Q Is modafinil an effective treatment for attention deficit hyperactivity disorder (ADHD) in young people?

METHODS

Embedded ImageDesign:

Multicentre randomised controlled trial.

Embedded ImageAllocation:

Unclear.

Embedded ImageBlinding:

Double blind.

Embedded ImageFollow up period:

9 weeks.

Embedded ImageSetting:

24 sites in the USA. Recruitment: November 2003 to June 2004.

Embedded ImagePatients:

246 young people (aged 6–17 years) with moderate or worse ADHD (Clinical Global Impression of Severity of Illness (CGI-S) rating ⩾4); above normal score on ADHD Rating Scale-IV (ADHD-RS-IV) School Version (⩾1.5 SD above age and gender norms; IQ ⩾80 (Wechsler Intelligence Scale). Exclusions: previous or current significant psychiatric disorder or active clinical comorbidities; current successfully managed ADHD; ADHD non-responsive to at least two previous treatments with stimulant therapies; previous sensitivity to stimulants.

Embedded ImageIntervention:

Following a 1–4 week washout period, flexible dose modafinil (titrated according to efficacy and tolerability; maximum dose 425 mg/day; minimum …

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