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
464
Daily oral dosing in the AM of optimized dose, ranging from 30- 70 mg. 5 week dose optimization, 3 week dose maintenance
Daily oral dosing in the AM of optimized dose, ranging from 18-72 mg. 5 week dose optimization, 3 week dose maintenance
Daily oral dosing in the AM for 8 weeks
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at Week 8
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Higher score indicates more severe symptoms.
Time frame: Baseline and week 8
Percentage of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at Week 8 - Last Observation Carried Forward (LOCF)
Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time frame: Week 8
Change From Baseline in Systolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment
Time frame: Baseline and up to 8 Weeks
Change From Baseline in Diastolic Blood Pressure at up to 8 Weeks - Last on Treatment Assessment
Time frame: Baseline and up to 8 weeks
Change From Baseline in Pulse Rate at up to 8 Weeks - Last on Treatment Assessment
Time frame: Baseline and up to 8 weeks
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Melmed Center
Scottsdale, Arizona, United States
Clinical Study Centers, LLC
Little Rock, Arkansas, United States
Synergy Clinical Research Center
National City, California, United States
Pacific Clinical Research Medical Group
Orange, California, United States
SDS Clinical Trials, Inc.
Orange, California, United States
Peninsula Research Associates, Inc.
Rolling Hills Estates, California, United States
PCSD - Feighner Research
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Neuropsychiatric Research Center of Orange County
Santa Ana, California, United States
Elite Clinical Trials
Wildomar, California, United States
...and 69 more locations