The primary objective of this study is to assess the time of onset of Vyvanse compared to placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
129
Following completion of the open-label dose optimization period and successful titration to an optimal dose of Vyvanse™, subjects will take their optimized dose of Vyvanse™ (30, 50 or 70 mg/day).
Placebo
Clinical Study Centers, LLC
Little Rock, Arkansas, United States
Univ. of CA, Irvine Child Development Center
Irvine, California, United States
Shire Clinical Research Site
Wildomar, California, United States
Vince and Associates Clinical Research
Onset of Effect of Vyvanse
The onset of effect will be defined as the first assessment time showing statistical significance between Vyvanse and placebo as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Deportment scale. The degree of impairment is rated from 0 (normal) to 6 (maximal).
Time frame: Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.
Duration of Effect of Vyvanse
Duration of effect will be defined as the first time point at which there is a non-significant difference between Vyvanse and placebo after a time point at which there is a significant difference between the two treatment groups as measured by SKAMP Deportment Scores. The degree of impairment is rated from 0 (normal) to 6 (maximal).
Time frame: Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose.
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Overland Park, Kansas, United States
Center for Psychiatry & Behavioral Medicine Inc
Las Vegas, Nevada, United States
Duke Child & Family Study Center
Durham, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Shire Clinical Research Site
Houston, Texas, United States
Shire Clinical Research Site
Lubbock, Texas, United States