RecruitingPhase 4ACTRN12609000271202

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.


Sponsor

Brain Resource Pty Ltd

Enrollment

1,344 participants

Start Date

Apr 1, 2009

Study Type

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

Sex: Both males and femalesMin Age: 6 YearssMax Age: 17 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at what brain, thinking, and genetic patterns are linked to ADHD in children and teenagers. It also aims to find out which of these patterns can predict how well a child will respond to methylphenidate (a common ADHD medication like Ritalin). Understanding these patterns could help doctors choose the best treatment for each child more quickly. You may be eligible if: - Your child is between 6 and 17 years old - Your child has been diagnosed with ADHD according to standard medical guidelines (DSM-IV) - Your child scores above the threshold on the standard ADHD rating scale - Your child is a candidate for methylphenidate treatment - Your child has never taken methylphenidate or other stimulant medications before (or has not taken them recently) - Your child is fluent in English or Dutch You may NOT be eligible if: - Your child has previously taken or is currently taking methylphenidate or other stimulant medication - Your child has had a brain injury causing loss of consciousness - Your child has severe difficulties with vision, hearing, or hand movement that would prevent completing the tests Talk to your doctor about whether this trial might be right for you.

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

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)

Auckland, New Zealand

Rhode Island, United States of America

Bryanston, South Africa

Nijmegen, Netherlands

North Carolina, United States of America

California, United States of America

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ACTRN12609000271202