The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
549
Daily oral dosing in the AM ranging from 30- 70 mg. 4 week forced dose titration, 2 week dose maintenance
Daily oral dosing in the AM ranging from 18-72 mg. 4 week force dose titration, 2 week dose maintenance
Daily oral dosing in the AM for 6 weeks
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 6
The ADHD-RS-IV was developed to measure the behaviors of children with ADHD and is commonly used in clinical studies of ADHD. The ADHD-RS-IV consisted of 18 items designed to reflect current symptomatology of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition-Text Revision (DSM-IV-TR) criteria. Each item was scored on a 4-point scale ranging from 0 (reflecting no symptoms) to 3 (reflecting severe symptoms) with total scores ranging from 0-54, Higher score = more severe symptoms.
Time frame: Baseline, Week 6
Percentage of Participants With an Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 6
The Clinical Global Impressions Scale permits a global evaluation of the participant's severity of illness and improvement over time. The scale included a severity of illness item and a global improvement item. The investigator performed the CGI-I to rate the improvement of a participant's ADHD symptoms based on a 7-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; or 7=very much worse.). Percentage of participants with an improved measurement (response of very much improved and much improved) is reported.
Time frame: Week 6
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Harmonex Neuroscience Research, Inc.
Dothan, Alabama, United States
Center for Advanced Improvement
Tucson, Arizona, United States
Clinical Study Centers, LLC
Little Rock, Arkansas, United States
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National City, California, United States
Pacific Sleep Medicine, A Medical Corporation
Oceanside, California, United States
Neuropsychiatric Research Center for Orange County
Orange, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
PCSD - Feighner Research
San Diego, California, United States
...and 85 more locations