International Study to Predict Optimised Treatment in Children and Adolescents with Attention Deficit/Hyperactivity Disorder
International Study to Predict Optimised Treatment response to short-acting methylphenidate in children and adolescents diagnosed with Attention Deficit/Hyperactivity Disorder (ADHD) as compared to matched healthy controls.
Brain Resource Pty Ltd
1,344 participants
Apr 1, 2009
Interventional
Conditions
Summary
The primary purposes of the iSPOT-A study are 1) to identify objective markers of ADHD, using cognitive, brain and genetic markers, and 2) to identify objective markers that predict treatment response to short-acting methylphenidate using cognitive, brain and genetic markers.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Once Baseline testing is completed, ADHD subjects will be dosed with short-acting methylphenidate as per local/country standard of care. Therefore, the length of treatment will differ and is based on the subjects response. Baseline testing consists of a clinical interview and medical history, a pregnancy test (for females of childbearing potential), web-based questionnaire, psychophysiology data collection, touchscreen cognitive testing, saliva collection for Deoxyribonucleic acid (DNA) analysis. A urine sample may be requested to rule out current illicit drug use. Structural and Functional Magnetic Resonance Imaging (MRI) will be performed at selected sites and in 10% of subjects. This part of the baseline assessment is optional. Baseline testing is expected to take up to 7 hours and may be completed over 2 days. Recommended Dosage: 5 mg twice daily given as oral tablets with gradual increments of 5 to 10 mg weekly. Daily dosage above 60 mg is not recommended.
Locations(6)
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For the most up-to-date information, visit the official listing.
ACTRN12609000271202