Magazine article Clinical Psychiatry News

Modafinil Treats Core Symptoms of ADHD. (Children Aged 6-13)

Magazine article Clinical Psychiatry News

Modafinil Treats Core Symptoms of ADHD. (Children Aged 6-13)

Article excerpt

SAN FRANCISCO - The novel wake-promoting agent modafinil improves the core symptoms of attention-deficit hyperactivity disorder in children both at school and home, according to two randomized, double-blind clinical trials presented at the annual meeting of the American Psychiatric Association.

On the basis of the results of these phase II trials, Cephalon Inc., modafinil's manufacturer, plans to begin a definitive phase III trial later this year with an eye toward eventually seeking Food and Drug Administration approval for an indication for use of the drug in treating ADHD, according to James M. Swanson, Ph.D., director of the Child Development Center at the University of California, Irvine.

Modafinil (Provigil) is now marketed for treatment of excessive daytime sleepiness associated with narcolepsy Modafinil has. made substantial inroads into the traditional use of stimulants for this purpose because it doesn't cause insomnia and has a low abuse potential.

Animal studies indicate that modafinil has an activating effect on the anterior cingulate gyrus, an area of the brain that plays a prominent role in executive function. This and other observations prompted researchers to conduct an open-label study in which modafinil brought symptomatic improvement in children with attention-deficit hyperactivity disorder (ADHD). That, in turn, prompted the two Cephalon-sponsored phase II trials,

Dr. Swanson reported on 48 children with ADI-ID aged 6-13 years who were randomized at three medical centers to either placebo or modafinil at dosages of 100 mg, 200 mg, 300 mg, or 400 mg once daily for 4 weeks. Children weighing 30kg or more who were randomized to high-dose therapy received 400 mg/day of modafinil; those weighing less received 300 mg/day, which is higher than the standard dosage for narcolepsy.

Patients receiving the 300- or 400-mg dosage of modafinil showed significant improvement in both teacher and parent ratings on the ADHD Rating Scale. …

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