Effects of modafinil in children with attention-deficit/hyperactivity disorder: An open-label study

Objective: To examine the effect of once-daily dosing of modafinil, a stimulant that has a long duration of action, on clinical features of attention-deficit/hyperactivity disorder (ADHD) in children. Method: An open-label design was used to compare the Conners Parent and Teacher Rating Scale-Revised (L) (CPRS, CTRS), the ADHD Rating Scale-IV, and the Test of Variables of Attention (TOVA), without and with medication, in children with ADHD. Eleven children with ADHD, ranging in age from 5 to 15 years, took modafinil for an average of 4.6 weeks. Results: Average TOVA ADHD scores improved by 2.43 SD (p =.0009). CTRS and CPRS ADHD index T scores improved by an average of 14.1 (p =.0009) and 17.7 points (p =.001), respectively. The mean ADHD Rating Scale-IV scores improved from the 88th percentile to the 75th percentile (p=.047). One subject withdrew from the study because of an adverse event that was resolved completely with medication withdrawal. Other side effects were mild and responded to dose adjustment. No subjects required more than one dose per day. Conclusions: Modafinil may be a useful once-daily treatment for children with ADHD. Further study using a double-blind, placebo-controlled design is needed.