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

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

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.

Study Overview

• Status: Terminated
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Other: no intervention. measure eye movement data

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Wisconsin Institutes of Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

children

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; healthy children without ADHD or other mental health issues	Other: no intervention. measure eye movement data
ADHD; children diagnosed with ADHD	Other: no intervention. measure eye movement data

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Luis C Populin, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): September 11, 2019
• Study Completion (Actual): September 11, 2019

Study Registration Dates

• First Submitted: January 6, 2016
• First Submitted That Met QC Criteria: May 1, 2018
• First Posted (Actual): May 14, 2018

Study Record Updates

• Last Update Posted (Actual): December 10, 2021
• Last Update Submitted That Met QC Criteria: November 26, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: 2015-0857; A536200 (Other Identifier: UW Madison); SMPH\DPT NEUROSCIENCE (Other Identifier: UW Madison); Protocol Version 8/1/2019 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No