Attention Deficit Hyperactivity DisorderNCT03523663
System for Determining Ideal Drug Doses for ADHD - Stages 1 and 2
An observational study of Attention Deficit Hyperactivity Disorder, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 11 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: children
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wisconsin Institutes of Medical Research
Madison, Wisconsin, 53705
About this study
Official title: Algorithm to Quantitatively Determine the Ideal Drug Dose to Treat Attention Deficit Hyperactivity Disorder
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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- no intervention. measure eye movement data
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention. measure eye movement dataOther
| Study group | Role | What they receive |
|---|---|---|
| Control | healthy children without ADHD or other mental health issues Receives: Other: no intervention. measure eye movement data | |
| ADHD | children diagnosed with ADHD Receives: Other: no intervention. measure eye movement data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task choice
Subjects will perform different cognitive tasks and we will record their choices.
Measured: At the time of testing (the investigators are measuring acute effects, not following outcomes based on a treatment)
Reaction time
The investigators record how long it took them to make their choices.
Measured: At the time of testing (the investigators are measuring acute effects, not following outcomes based on a treatment)
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.
Measured: At the time of testing (the investigators are measuring acute effects, not following outcomes based on a treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study startJan 2016
- Primary completion11 Sep 2019
- Study completion11 Sep 2019
Why it stopped: difficulty recruiting pediatric participants followed by a prolonged shut down due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis C Populin, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523663
- Sponsor's protocol ID
- 2015-0857
- Other IDs
- A536200, SMPH\DPT NEUROSCIENCE, Protocol Version 8/1/2019
- Status last verified
- Nov 2021
- First submitted
- 6 Jan 2016
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Algorithm to Quantitatively Determine the Ideal Drug Dose to Treat Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT03523663
- Acronym / sponsor ID
- 2015-0857
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: difficulty recruiting pediatric participants followed by a prolonged shut down due to COVID-19
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 11 Sep 2019 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: no intervention. measure eye movement datahealthy children without ADHD or other mental health issues |
| ADHD | – | Other: no intervention. measure eye movement datachildren diagnosed with ADHD |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention. measure eye movement data | Other | ADHD, Control |
Primary outcome
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.
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.
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.
Results and safety
The study was stopped early (reason given: difficulty recruiting pediatric participants followed by a prolonged shut down due to COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis C Populin, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: difficulty recruiting pediatric participants followed by a prolonged shut down due to COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Task choice (time frame: At the time of testing (the investigators are measuring acute effects, not following outcomes based on a treatment)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.