The aim of the iSPOT-A study is to: 1. identify brain, genetic and cognitive markers of Attention Deficit/Hyperactivity Disorder, and 2. identify brain, genetic and cognitive markers that predict treatment response to short-acting methylphenidate in children and adolescents diagnosed with Attention Deficit/Hyperactivity Disorder.
This is a multi-center, open-label effectiveness trial to identify objective indicators of treatment response in ADHD subjects (versus healthy controls) using cognitive and brain function measures, brain structure and genetic measures in subjects diagnosed with ADHD. At least 672 naïve and treatment experienced subjects with ADHD will be enrolled from approximately 10 primary care centers. These patients are to be outpatients. In addition, up to 672 healthy (non-ADHD) control subjects will be recruited who match the enrolled ADHD subjects in race, age, gender and years of education.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
1,344
Dosage: 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly. Daily dosage above 60 mg is not recommended.
Dosage: 9 to 20 mg once daily in the morning (with or without food) with gradual increments of 9 to 20 mg weekly. Daily dosage above 60 mg is not recommended.
Shanti Clinical Trials
Colton, California, United States
Center for Healing the Human Spirit
Tarzana, California, United States
Brain Resource Center
Englewood Cliffs, New Jersey, United States
Brain Resource Center
New York, New York, United States
To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalize' with acute drug treatment in ADHD.
Time frame: 6 weeks
To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months.
Time frame: 52 weeks
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Skyland Behavioral Health Associates , P.A.
Asheville, North Carolina, United States
Brain Dynamics Centre
Westmead, New South Wales, Australia
Brainclinics Diagnostics B.V.
Nijmegen, Gelderland, Netherlands