This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo during an 8-hour laboratory classroom day.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
86
20 mg capsule orally once a day for 7 days
orally once a day for 7 days
Novartis Investigative Site
Little Rock, Arkansas, United States
Novartis Investigative Site
Winter Park, Florida, United States
Novartis Investigative Site
Las Vegas, Nevada, United States
Novartis Investigative Site
Houston, Texas, United States
Change From Pre-dose (0 hr [Hour]) on the Swanson, Kotkin, Agler, M-Flynn & Pelham (SKAMP) Rating Scale Combined Score at 0.5 Hour During the 8- Hour Laboratory Classroom Day
SKAMP rating scale is comprised of 13 questions (7 questions on attention and 6 questions on deportment) evaluating classroom behavior; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78.
Time frame: 0 hr and 0.5 hr post-dose
Change From Pre-dose (0 hr) in SKAMP Combined Score at All Times Excluding the 0.5 Hour Timepoint (Hours 1, 2, 4, 6, 8)
SKAMP rating scale is comprised of 13 questions (7 questions on attention and 6 questions on deportment) evaluating classroom behavior; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 78.
Time frame: 0, 1, 2, 4, 6, and 8 hr
Change From Pre-dose in SKAMP Attention Score at All Timepoints (0.5, 1, 2, 4, 6, 8)
SKAMP attention sub-scale is comprised of 7 questions evaluating concentration in the classroom; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 42.
Time frame: 0, 0.5, 1, 2, 4, 6, and 8 hours
Change From Pre-dose in SKAMP Deportment Score
SKAMP deportment sub-scale is comprised of 6 questions on behavior in the classroom; answers to each question range from 0 (normal, no impairment) to 6 (maximum impairment) for a total possible combined score of 0 to 36.
Time frame: 0, 0.5, 1, 2, 4, 6 and 8 hours
Change From Pre-dose (0 hr.) in Permanent Product Measure of Performance (PERMP) Math Test-Attempted Scores at All Timepoints (0.5, 1, 2, 4, 6, 8)
Number of math questions attempted within a 10 minute period.
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Novartis Investigative Site
Lubbock, Texas, United States
Time frame: 0, 0.5, 1, 2, 4, 6 and 8 hours
Change From Pre-dose in Number of Math Questions Answered Correctly on the Permanent Product Measure of Performance (PERMP) Math Test
Number of math questions answered correctly within a 10 minute period.
Time frame: 0, 0.5, 1, 2, 4, 6 and 8 hours