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Provigil (Modafinil) Shows Promise for Treatment of Attention Deficit Hyperactivity Disorder in Children: Presented at USPMHC
By Jill Stein
Special to DG News
LAS VEGAS, NV -- October 29, 2002 -- Modafinil (Provigil) significantly improves the symptoms of attention deficit hyperactivity disorder (ADHD) in children, researchers announced here October 28 at the 15th Annual U.S. Psychiatric and Mental Health Congress.
Dr. Joseph Biederman, with Harvard Medical School in Boston, Massachusetts, presented the results of a multi-center study in which 248 children from six to 13 years of age diagnosed with ADHD according to Diagnostic and Statistical Manual-IV criteria were randomised to four weeks' treatment with one of four daily dose regimens of modafinil or placebo.
The modafinil groups received 300 to 400 mg once daily or as a split dose given in the morning and at mid-day (100 mg/200mg, 200mg/100 mg, 300mg /0 mg, or 200 mg/200 mg).
Approximately one-third of the children had taken stimulants within 30 days of screening. Most patients in each dosing group had combined inattentive-hyperactivity ADHD. The trial excluded children who had a history or a current diagnosis of pervasive development disorder, schizophrenia, or other psychotic disorders.
The primary study end point was the teacher-completed school version of the ADHD Rating Scale IV.
Results show that all the modafinil-treated groups had a decrease in ADHD symptoms. The treatment effect was most pronounced in the group assigned to 300 mg of modafinil given once a day (p<0.01). Overall, about 60 percent of children in this cohort had an improvement in ADHD symptoms compared with 30 percent of placebo patients.
The study also found that both the inattentiveness and hyperactivity components for the ADHD subscales were improved.
Modafinil was generally well tolerated. The most common adverse events occurring more frequently in the modafinil groups included insomnia and decreased appetite.
Modafinil is presently approved in more than 20 countries for the treatment of excessive daytime sleepiness associated with narcolepsy.
The study was supported by Cephalon, Inc. in West Chester, Pa.
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