A Randomized, Double-Blind, Placebo-Controlled Study of Modafinil Film-Coated Tablets in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder

摘要: Objective To evaluate the efficacy and tolerability of modafinil in children adolescents, ages 7 to 17, with attention-deficit/hyperactivity disorder (ADHD). Method In this 9-week, double-blind, flexible-dose study, patients were randomized once-daily (170-425 mg) or placebo. Assessments included ADHD Rating Scale-IV (ADHD-RS-IV) School Home Versions Clinical Global Impression Improvement (CGI-I) scale. Results Two hundred randomized. Modafinil produced significant reductions ADHD-RS-IV total scores at school (n = 128; mean change ± SD: −17.5 13.1 points) compared placebo 66; −9.7 10.3 points; p < .0001). Similarly, reduced home (−17.6 13.3 versus −7.5 11.8 Fifty-two percent 18% those met prestudy criteria for responder on CGI-I (p Randomization was associated significantly more insomnia, headache, decreased appetite, weight loss than randomization placebo, but discontinuation attributed adverse events did not differ statistically between treatment groups (modafinil, 5%; 6%). Conclusion Modafinil well tolerated symptoms