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

NCT ID: NCT03523663

Last Updated: 2021-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-09-11

Brief Summary

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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

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control

healthy children without ADHD or other mental health issues

no intervention. measure eye movement data

Intervention Type OTHER

ADHD

children diagnosed with ADHD

no intervention. measure eye movement data

Intervention Type OTHER

Interventions

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no intervention. measure eye movement data

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luis C Populin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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Wisconsin Institutes of Medical Research

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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A536200

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\DPT NEUROSCIENCE

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 8/1/2019

Identifier Type: OTHER

Identifier Source: secondary_id

2015-0857

Identifier Type: -

Identifier Source: org_study_id