A Comparison of Once-Daily and Divided Doses of Modafinil in Children With Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind, Placebo-Controlled Study
J Clin Psychiatry 2006;67(5):727-735
© Copyright 2016 Physicians Postgraduate Press, Inc.
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Objective: This randomized,
double-blind, placebo-controlled study assessed the
efficacy and tolerability of several modafinil dosing
regimens in children with
attention-deficit/hyperactivity disorder (ADHD) to determine
whether modafinil can be given once daily in
Method: Children and adolescents (age
range, 6-13 years) (N = 248) with DSM-IV-defined ADHD were enrolled in a 4-week,
double-blind, placebo-controlled study, conducted
February-May 2002. The group was assigned to
receive oral (100-mg tablets) modafinil 300 mg
once daily (300 mg in the morning followed by placebo at midday), modafinil 300 mg as a
divided dose (100/200 mg or 200/100 mg), or
matching placebo. In children weighing > = 30 kg, a
higher dose of 400 mg (200/200 mg) was evaluated.
Efficacy measures included the teacher-rated
School Version and clinician-rated Home Version of
the ADHD Rating Scale-IV and the parent-completed Conners' ADHD/DSM-IV Scales.
Results: 223 children completed the
study. Those who received modafinil 300 mg once
daily showed a significantly greater improvement (change from baseline) than those who
received placebo in symptoms of ADHD across all
rating scales and subscales (all p < .05). Divided
300-mg doses of modafinil provided some significant
but inconsistent improvements in ADHD symptoms. In children weighing > = 30 kg, modafinil 400
mg (200/200 mg) was significantly superior to placebo on clinician- and parent-completed
scales (all p < .05). Insomnia was the only adverse
event to occur with significantly greater frequency in
a modafinil group (200/100) than in the placebo group (14% vs. 2%) (p = .03).
Conclusion: Modafinil significantly
improved ADHD symptoms in children. Once-daily
dosing (300 mg) provided the most consistent
improvement in symptoms. All dosing regimens of modafinil were well tolerated.