Modafinil as a treatment for Attention-Deficit/Hyperactivity Disorder in children and adolescents: a double blind, randomized clinical trial.

Attention-Deficit/Hyperactivity Disorder (ADHD) is the most prevalent psychiatric disorder currently afflicting children and is among the most common chronic conditions affecting school-age children. Modafinil is structurally different from the psychostimulants that are typically used to treat ADHD and has been reported to be effective in improving the symptoms of ADHD. The aim of the present study was to further evaluate, under double blind and controlled conditions, the efficacy of modafinil for ADHD in children and adolescents as compared to methylphenidate. Patients included 60 outpatients, children (47 boys and 13 girls) between the ages of 6-15 who clearly met the DSM-IV-TR diagnostic criteria for ADHD. Subjects were recruited from an outpatient child and adolescent clinic for a 6 week double blind, randomized clinical trial. All study subjects were randomly assigned to receive either treatment with modafinil film coated tablet (in doses of 200-300 mg/day) depending on weight (200 mg/day for <30 kg and 300 mg/day for >30 kg) (group 1) or methylphenidate (in doses of 20-30 mg/day) depending on weight (20 mg/day for <30 kg and 30 mg/day for >30 kg) (group 2). The principal measure of outcome was the Teacher and Parent ADHD Rating Scale-IV. Patients were assessed at baseline and at 21 and 42 days after the medication started. No significant differences were observed between the two groups 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.