Modafinil in children with attention-deficit hyperactivity disorder.

Previous clinical evidence suggested that modafinil may improve clinical features of children with attention-deficit hyperactivity disorder. To test this hypothesis, a randomized, double-blind, placebo-controlled study design was used. Of 24 children initially randomized into the study, 11 control subjects and 11 treatment patients completed the study, with evaluation before medication and after 5 to 6 weeks. The average Test of Variables of Attention attention-deficit hyperactivity disorder z score improved by 2.53 S.D.s for the modafinil group compared with a decline of 1.02 for control patients (P < or = 0.02). Conners Rating Scales ADHD total t scores for the modafinil group improved from 76.6 to 68.2 compared with improvement from 77.7 to 76.0 for control subjects (P = 0.04). Ten of 11 treatment patients were reported as "significantly" improved, whereas eight of 11 control subjects were reported as manifesting "no" or "slight" improvement (P < 0.001). Adverse effects were few and manageable, with no anorexia. Modafinil may be a useful treatment for children with ADHD, particularly when anorexia limits use of stimulants.