ADHD in Children
Visual Abstract
Efficacy and safety of modafinil film-coated tablets in children and adolescents with attention-deficit/hyperactivity disorder: results of a randomized, double-blind, placebo-controlled, flexible-dose study
Modafinil in Children with ADHD
Joseph Biederman , James M Swanson, Sharon B Wigal, Christopher J Kratochvil, Samuel W Boellner, Craig Q Earl, John Jiang, L Greenhill
Summarized by:
May 5, 2023
study source
Pediatrics
Dec 2005
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What they studied
This study wanted to see whether modafinil could improve ADHD symptoms in children with ADHD.
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What they found
Children who received modafinil experienced significant reductions in ADHD symptoms and general well-being.
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What this means
Modafinil may be a potential treatment option for children with ADHD, though more studies are needed to evaluate its safety and effectiveness as an ADHD treatment.
Efficacy and safety of modafinil film-coated tablets in children and adolescents with attention-deficit/hyperactivity disorder: results of a randomized, double-blind, placebo-controlled, flexible-dose study
Objectives
The study wanted to see whether modafinil could improve ADHD symptoms in children.
Modafinil is a drug currently approved to treat sleepiness in patients with narcolepsy or shift-work disorder.
There is some evidence that modafinil may help with ADHD symptoms.
Unlike stimulant medications, the most commonly prescribed treatment for ADHD, modafinil doesn’t have a significant addiction risk.
Study Quote
Modafinil, which is structurally and pharmacologically different from other agents that are used for the treatment of children with attention-deficit/hyperactivity disorder (ADHD), selectively activates the cortex and has low potential for abuse. Initial studies of the use of modafinil t...
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Methods
The researchers recruited children with ADHD for a clinical trial comparing modafinil with a placebo control.
What is the placebo effect?
After nine weeks of treatment, researchers assessed whether modafinil improved ADHD and well-being.
Study Quote
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 ...
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Results
The data showed that the children randomly selected to receive modafinil did much better than those in the control group.
They had significantly less severe ADHD symptoms after two weeks of treatment.
A clinical trial found that modafinil may reduce ADHD symptoms in children.
Their doctors were also more likely to notice improvements in their well-being, as shown below:
A clinical trial found that modafinil may improve overall mental well-being in children with ADHD.
In addition to general improvements in ADHD, those who took modafinil also demonstrated specific improvements in their behavior, cognition, and hyperactivity.
A small clinical trial found that children who received modafinil better cognition, better behavior, less hyperactivity, and improved ADHD symptoms.
Many children in the study did experience side effects from modafinil, most commonly insomnia, headache, and decreased appetite.
A clinical trial of modafinil in children with ADHD found that the top side effects were insomnia, headache, and decreased appetite.
Study Quote
A total of 248 subjects were randomly assigned 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 placeb...
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Conclusions
Based on the data, the authors concluded that modafinil could improve ADHD symptoms in children with ADHD. There were side effects, but it was generally well tolerated.
Study Quote
Modafinil film-coated tablets significantly 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.