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

• ClinicalTrials.gov Identifier: NCT03523663
• Recruitment Status: Terminated
• First Posted: May 14, 2018
• Last Update Posted: December 10, 2021
• Sponsor: University of Wisconsin, Madison
• Information provided by (Responsible Party): University of Wisconsin, Madison

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
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: January 2016
• Actual Primary Completion Date: September 11, 2019
• Actual Study Completion Date: September 11, 2019

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Task choice [ Time Frame: 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.
2. Reaction time [ Time Frame: 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.
3. Eye position [ Time Frame: 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

• Ages Eligible for Study: 8 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

children

Criteria

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

United States, Wisconsin

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

More Information

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT03523663
• 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 )
• First Posted: May 14, 2018
• Last Update Posted: December 10, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases