TORONTO – Modafinil is safe and effective in treating pediatric attention-deficit hyperactivity disorder, decreasing symptom scores twice as much as placebo, according to two posters presented at the joint annual meeting of the American Academy of Child and Adolescent Psychiatry and the Canadian Academy of Child and Adolescent Psychiatry.
The posters, sponsored by Cephalon Inc., concluded that children tolerated the film-coated tablets well in dosages of up to 425 mg/day. Insomnia, headache, and decreased appetite were the most commonly reported adverse events. Those adverse events typically occurred during the first 2 weeks of therapy and decreased thereafter, said Dr. Christopher Kratochvil of the University of Nebraska.
The posters analyzed three multicenter, double-blind studies that included a total of 633 children aged 6–17 years. Two of the studies were identical 9-week flexible-dosing trials. The third was a 7-week fixed-dose placebo-controlled study (340 or 425 mg/day), followed by a 2-week period in which half the modafinil group was switched to placebo without tapering while the other half continued modafinil treatment.
Adverse events were more common in the active group than the placebo group and included insomnia (27% vs. 4%), headache (20% vs. 13%), and decreased appetite (16% vs. 3%).
The adverse events were all classified as mild to moderate. They peaked in the first 2 weeks of treatment and subsequently subsided. No apparent association was found between adverse events and dosage.
There were no significant changes in heart rate or blood pressure between the groups, and the abrupt discontinuation of the drug did not lead to acute withdrawal symptoms or rebound effects.
The drug effectively reduced the symptoms of ADHD, especially hyperactivity and inattention, reported Dr. Joseph Biederman of Massachusetts General Hospital. The effects were consistent whether assessed by physician, parent, or teacher.
Physicians assessed almost 50% of the active groups as much improved at the end of treatment, compared with 20% of the placebo group.
Parents and teachers rated symptom improvement of those in the active group at about twice that of the placebo group in all areas: oppositional behavior, inattention, and hyperactivity.
Symptom improvement differed significantly from placebo at week 2 of treatment and continued to diverge throughout the course of all three studies.