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Modafinil (Provigil) Pediatric Formulation Shows Early, Sustained Effects in Attention Deficit/Hyperactivity Disorder

By Bruce Sylvester

ATLANTA, GA -- May 26, 2005 -- Pediatric formulation modafinil (Provigil) is effective quickly, has a sustained effect and is well tolerated in children with attention deficit/hyperactivity disorder (ADHD) ages 6 to 17 years, researchers reported here on May 24^th at the 158^th Annual Meeting of the American Psychiatric Association (APA).

"This study not only shows that this medication is effective and rapid in onset for the treatment of pediatric ADHD," said presenter and lead investigator Joseph Biederman, Professor of Psychiatry, Harvard Medical School, and Chief of Pediatric Neuropsychopharmachology, Massachusetts General Hospital, Boston, Massachusetts, United States. "It also gives the clear signal that here we have a medication that can be used by physicians to treat ADHD in children who cannot tolerate amphetamine salts or for whom the clinician simply prefers not to use amphetamine salts."

The investigators randomized subjects diagnosed with ADHD aged 6 to 17 years to receive 7 weeks of double-blind, fixed-dose modafinil (n = 120) or placebo (n = 63). This first phase of the study was followed by a 2-week withdrawal period, in which half of modafinil subjects were switched to placebo (without tapering) and half continued using modafinil.

The researchers administered once-daily modafinil, titrating up from 85 mg/day over 7 or 9 days to daily doses of 340 mg/day for subjects weighing less than 30 kg, and 425 mg per day for subjects weighing 30 kg or more.

They assessed treatment efficacy using the School and Home ADHD Rating Scale-IV (ADHD-RS-IV) total score change from baseline to last study evaluation.

They found that, after the first week, children treated with modafinil achieved significantly greater improvements in School ADHD-RS-IV scores versus placebo-treated patients(P = .009). The effect remained active through week 7 (score change -17.2 with modafinil and -8.2 points with placebo; P < .0001).

They also found that the effect size was 0.75 for School ADHD-RS-IV total score and that subjects on the active agent showed statistically significantly improved total scores on the Home ADHD-RS-IV compared with placebo subjects.

"ADHD symptoms did not rebound upon abrupt discontinuation," the authors noted.

The most common adverse events were insomnia at 24% with modafinil and 0% with placebo, headache (17% vs. 14%, respectively), and decreased appetite (14% vs. 2%, respetively)."

The research was supported by Cephalon.


[Presentation title: Modafinil Pediatric Formulation Has Early and Sustained Effect in ADHD. Abstract 48]

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