Efficacy And Safety Of Modafinil Film-coated Tablets In Children And Adolescents With Attention-deficit/hyperactivity Disorder: Results Of A Randomized, Double-blind, Placebo-controlled, Flexible-dose Study
|Trial Design||Double blind|
|Trial Length||1-6 months|
|Number of Subjects||246|
|Age Range||7-12, 13-17|
Supplementation of modafinil at a variable dose of 170-425mg daily over the course of six weeks was associated with significant improvements in attention (with 48% of the sample reporting 'much' or 'very much' when asked how symptoms were improved relative to 17% in placebo) in youth as assessed by the ADHD-RS-IV and CGI-I rating scales. Both inattention and hyperactivity were beneficially influenced, and cognition (impaired by inattention) was significantly improved as well.
Appetite was reported as a side-effect in 16% of participants, which was significantly more than placebo. There was a trend for weight gain in placebo and weight loss in modafinil, but neither reached significance.