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The Efficacy and Safety of Modafinil in Children and Adolescents with ADHD: Results of a Randomized,

The Efficacy and Safety of Modafinil in Children and Adolescents with ADHD: Results of a Randomized,

  1. Jatelka
    Originally published in Paediatrics.

    ABSTRACT.
    Objective. Modafinil, which is structur-ally and pharmacologically different from other agents that are used for the treatment of children with attention-deficit/hyperactivity disorder (ADHD), selectively acti-vates the cortex and has low potential for abuse. Initial studies of the use of modafinil to treat ADHD showed significant improvements in the core symptoms of the disorder, namely inattention, hyperactivity, and impulsivity. This study evaluated a new formulation of modafinil (modafinil film–coated tablets) in children and adolescents with ADHD. Methods. This 9-week, multicenter, randomized, double-blind, placebo-controlled, flexible-dose study evaluated the film-coated tablet formulation of modafinil, which was titrated to an optimal dose on the basis of efficacy and tolerability (range: 170–425 mg once daily). Efficacy was assessed by clinicians who completed the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) based on interviews with teachers (School Version) and parents (Home Version) and the Clinical Global Impression of Improvement scale. Safety evaluation was based on assessments of adverse event reports, laboratory tests, vital signs, and body weight.
    Results. A total of 248 subjects were randomly as-signed in a 2:1 ratio, and 246 were treated with modafinil (n  164) or placebo (n  82). Treatment groups were comparable with respect to demographics and baseline characteristics. Intention-to-treat analysis (ITT) showed that compared with placebo, treatment with modafinil significantly improved the core symptoms of ADHD as shown by greater reductions in the ADHD-RS-IV School Version total scores from baseline to final visit (mean change [SD]: 15.0 [11.8] vs 7.3 [9.7]) (effect size: 0.69; 95% confidence interval: 0.57–0.82). Significant improve-ments were observed with modafinil treatment on the ADHD-RS-IV School Version at week 1, with improve-ments maintained throughout the study. Similar differences in symptom improvements were observed on the ADHD-RS IV Home Version between modafinil-treated and placebo-treated patients. Treatment with modafinil also significantly reduced subscale scores for inattention and hyperactivity-impulsivity on both School and Home Versions compared with placebo. At the final visit, 48%of modafinil treated patients were rated as “much” or “very much” improved in overall clinical condition compared with 17% of placebo-treated patients (Clinical Global Impression of Improvement). Most adverse events were mild to moderate in severity, and the major-ity resolved during treatment. The most commonly re-ported adverse events in the modafinil group were in-somnia (29%), headache (20%), and decreased appetite (16%). Three percent of modafinil-treated patients and 4% of placebo-treated patients discontinued treatment because of adverse events.
    Conclusions. Modafinil film–coated tablets signifi-cantly improved ADHD symptoms at school and home as evaluated by clinicians, teachers, and parents. Treatment with once-daily modafinil was generally well tolerated, with few discontinuations as a result of adverse events.
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