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

NCT03523663 | Terminated

• 4 other identifiers: 2015-0857A536200SMPH\DPT NEUROSCIENCEProtocol Version 8/1/2019
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

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

Interventions

no intervention. measure eye movement data OTHER

ADHD; Control

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

Wisconsin Institutes of Medical Research

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Luis C Populin, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: May 14, 2018
• Study Start: January 1, 2016
• Primary Completion: September 11, 2019
• Study Completion: September 11, 2019
• Last Updated: December 10, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)