System for Determining Ideal Drug Doses for ADHD - Stages 1 and 2

Study Overview
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Brief Summary
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The goal of this study is to create a formal, quantitative methodology to determine what is the most beneficial dose of Central Nervous System (CNS) stimulant (Ritalin, methylphenidate) to improve cognitive and behavioral function of children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) individually. If successful, it will change the way in which the dose of CNS stimulant for treating ADHD is determined for children in need of therapeutic intervention. The project will be focused on developing the necessary methodology to analyze the children's data with the drift-decision model (DDM), and to develop the required technology, i.e., a computer game with which to measure cognitive/behavioral function and its validation with eye-tracking measurements.

Official Title
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Algorithm to Quantitatively Determine the Ideal Drug Dose to Treat Attention Deficit Hyperactivity Disorder

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Other: no intervention. measure eye movement data


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 8-12 years of age; Accompanied by caregiver (parent or legal guardian); Able to understand and speak English; Able to read basic English; No counseling or current/past history of psychiatric illness, as confirmed by the Child Behavior Checklist (CBCL) and Conner's rating scale Exclusion Criteria: Active psychosis or suicidality History of primary psychotic disorder (e.g., schizophrenia) or bipolar disorder Recent (past 2 weeks) substance abuse or dependence History of brain damage or significant developmental delay Unstable medical condition such as newly diagnosed Type I Diabetes or Rheumatoid arthritis Use of oral steroids Participation in the last 30 days in a clinical study involving an investigational drug Current use of a psychotropic medicine

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>healthy children without ADHD or other mental health issues | Other: no intervention. measure eye movement data<br> <br> |
| ADHD<br>children diagnosed with ADHD | Other: no intervention. measure eye movement data<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Task choice | Subjects will perform different cognitive tasks and we will record their choices. | At the time of testing (the investigators are measuring acute effects, not following outcomes based on a treatment) | 
| Reaction time | The investigators record how long it took them to make their choices. | At the time of testing (the investigators are measuring acute effects, not following outcomes based on a treatment) | 
| Eye position | The tasks are eye movement based. The investigators record where the subjects were looking as voltages, which are converted to x/y coordinates through a calibration, throughout the different events of the task. | At the time of testing (the investigators are measuring acute effects, not following outcomes based on a treatment) |