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
Inclusion Criteria1
- Meet Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria for primary diagnosis of ADHD, have an Attention Deficit / Hyperactivity Disorder Rating Scale (ADHD-RS IV) score > 6 for inattention and/or hyperactivity-impulsivity, subject is a candidate for methylphenidate, and is stimulant naive or stimulant free. Fluent and literate in English or Dutch.
Exclusion Criteria1
- Prior or recent use of methylphenidate of other stimulant medication. History of brain injury/blow resulting in loss of consciousness. Severe impediment to vision, hearing and/or hand movement which may interfere with their ability to complete the protocol required tests.
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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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ACTRN12609000271202