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

Terminated

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Other: no intervention. measure eye movement data

• Registration Number: NCT03523663
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2018-05-01
• Study First Posted: 2018-05-14
• Primary Completion: 2019-09-11
• Study Completion: 2019-09-11
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-26
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	no intervention. measure eye movement data	healthy children without ADHD or other mental health issues
ADHD	no intervention. measure eye movement data	children diagnosed with ADHD

Primary Outcome Measures

Name	Time	Method
Reaction time	At the time of testing (the investigators are measuring acute effects, not following outcomes based on a treatment)	The investigators record how long it took them to make their choices.
Task choice	At the time of testing (the investigators are measuring acute effects, not following outcomes based on a treatment)	Subjects will perform different cognitive tasks and we will record their choices.
Eye position	At the time of testing (the investigators are measuring acute effects, not following outcomes based on a treatment)	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.

Trial Locations

Locations (1)

Wisconsin Institutes of Medical Research; 🇺🇸 Madison, Wisconsin, United States