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New Study on Provigil/modafinil for ADHD

Posted by Rick on October 31, 2002, at 16:58:40

Modafinil May Have Role in the Treatment of ADHD in Children

By Jill Stein

LAS VEGAS (Reuters Health) Oct 29, 2002 - Modafinil, which is approved only for the treatment of excessive daytime sleepiness associated with narcolepsy, significantly improves the symptoms of attention deficit hyperactivity disorder (ADHD) in children, according to preliminary results reported at the 15th Annual U.S. Psychiatric and Mental Health Congress.

Dr. Joseph Biederman, professor of psychiatry at Harvard Medical School in Boston, Massachusetts, and colleagues elsewhere randomized 248 children from 6 to 13 years of age with ADHD to treatment with one of four doses of modafinil or placebo. The modafinil groups received the drug 300 to 400 mg once daily or as a split dose given in the morning and at mid-day (100 mg/200 mg, 200 mg/100 mg, 300 mg /0 mg, or 200 mg/200 mg).

About one-third of the children had taken stimulant medications in the prior 30 days.

The primary efficacy measure was the teacher-completed school version of the ADHD Rating Scale IV, an 18-item scale used to assess behavior in children that has been widely validated.

Results of the four-week trial showed that all of the modafinil-treated groups had a decrease in ADHD symptoms of inattention and hyperactivity. The treatment effect was most dramatic in the group receiving 300 mg of modafinil once a day. Overall, about 60% of children in this group had an improvement in symptoms versus 30% of children who got placebo.

Findings on the Conners' ADHD/DSM-IV Scale: Parent Version (CADS-P), a 26-item scale that assesses behavior including inattention, temper outbursts, and mood changes, supported the results of the teachers' ratings.

Modafinil was generally well tolerated. The most common adverse events occurring more frequently in the modafinil groups included insomnia and decreased appetite.

"There is a need for new medications to treat attention deficit hyperactivity disorder since existing medications like the stimulants are not effective in all patients," Dr. Biederman told Reuters Health. "In fact, 30% of patients do not adequately respond or cannot tolerate stimulant treatment."

He added that future studies are needed to help determine the optimal dosing regimen for modafinil for the management of pediatric ADHD.


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URL: http://www.dr-bob.org/babble/20021025/msgs/125974.html