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

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Terminated

CT.gov ID

NCT03523663

Collaborator

(none)

Enrollment

Location

44.3

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Other: no intervention. measure eye movement data

Study Design

Study Type:

Observational

Actual Enrollment :

46 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Sep 11, 2019

Actual Study Completion Date :

Sep 11, 2019

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wisconsin Institutes of Medical Research	Madison	Wisconsin	United States	53705

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Wisconsin, Madison

ClinicalTrials.gov Identifier:

NCT03523663

Other Study ID Numbers:

2015-0857
A536200
SMPH\DPT NEUROSCIENCE
Protocol Version 8/1/2019

First Posted:

May 14, 2018

Last Update Posted:

Dec 10, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Hyperkinesis

Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Dec 10, 2021