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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03523663
• Other study ID #: 2015-0857
• Secondary ID: A536200SMPH\DPT
• Status: Terminated
• Start date: January 2016
• Est. completion date: September 11, 2019

Study information

• Verified date: November 2021
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: September 11, 2019
• Est. primary completion date: September 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Other:
• no intervention. measure eye movement data

Locations

Country	Name	City	State
United States	Wisconsin Institutes of Medical Research	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)