About the Study
During the three-week study period, investigators administered a placebo to 200 participants, aged 6 to 12 years, for three days before randomizing them to receive, once daily, either extended-release mixed amphetamine salts or a weight-based dose of atomoxetine. All participants were diagnosed with ADHD using the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR
Dosing of the two medications adhered to the approved dosing in their respective product labels. Standard doses of mixed amphetamine salts were administered as 10 milligrams (mg) on days four to six, 20 mg on days seven to 13 and 30 mg on days 14 to 21. Standard doses of atomoxetine were administered as 0.5 mg per kilogram (kg) of body weight on days four to six and 1.2 mg/kg on days seven to 21.
The researchers observed the participants in four "simulated" classroom sessions (known as analog classrooms), each on a Saturday and lasting 12 hours. At the first visit after completion of an adequate washout interval, children received placebo. This was followed by sessions on active drug at weeks one, two and three. The investigators measured SKAMP scores before the children received active medication (baseline) and during each of the three treatment weeks at 2.5-hour increments during the 12-hour classroom sessions.
Both mixed amphetamine salts and atomoxetine had similar tolerability profiles. The majority of side effects reported during the trial were mild or moderate and similar to those seen in previous clinical trials of the medications. These included decreased appetite, difficulty falling asleep and headache for both medications, and vomiting, somnolence and nausea for atomoxetine.
"As a stimulant medication, which as a class have been used safely and effectively in ADHD treatment for more than 60 years, once-daily mixed ampheta
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Contact: Tom Vasich
tmvasich@uci.edu
949-824-6922
Porter Novelli
4-May-2004