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NCT04349917 · ClinicalTrials.gov registry record · Phase 4
Large-scale Brain Organization During Cognitive Control in ADHD
A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 4
- Development phase
- 37
- Enrollment target
NCT04349917 is a Phase 4 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 37 participants.
The verdict
NCT04349917, a Phase 4 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 37 participants
- Enrollment target
Study Summary
The purpose of this study is to test whether children with attention-deficit/hyperactivity disorder (ADHD) are impaired in the ability to flexibly adapt brain network organization in response to shifting cognitive demands during the exertion of cognitive control, by assessing changes in network dynamics resulting from stimulant administration in children with ADHD, and how those changes relate to behavioral and symptom improvements. Subjects will be children with ADHD aged 8-12. Subjects will participate in multiple testing sessions that include: diagnosis and eligibility screening, neuropsychological and behavioral testing, and, if eligible, MRI scans and a medication challenge. Children with ADHD who are enrolled in the medication challenge will undergo one MRI scan on placebo and one MRI scan on stimulant medication, counterbalanced and double-blind. Functional connectivity will be measured using functional MRI and innovative graph theoretical analytic tools will be implemented. Network metrics will be related to symptomatology and behavioral testing measures. It is hypothesized that stimulant administration in children with ADHD will increase flexibility in network reconfiguration in response to changing cognitive control demands as compared to when they are on placebo. It is further hypothesized that the degree to which brain network organization is changed will be related to the degree of improvement in cognitive control performance.
Interventions
- OTHER Placebo
- DRUG Methylphenidate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2016-12-16 |
| Est. Completion | 2020-03-14 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04349917
The ClinicalTrials.gov registry entry for NCT04349917 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04349917 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04349917 about?
NCT04349917 is a clinical study titled "Large-scale Brain Organization During Cognitive Control in ADHD". The purpose of this study is to test whether children with attention-deficit/hyperactivity disorder (ADHD) are impaired in the ability to flexibly adapt brain network organization in response to shifting cognitive demands during the exertion of cognitive control, by assessing changes in network dyna...
What is the current status of trial NCT04349917?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 37 participants. The study started on 2016-12-16. Estimated completion is 2020-03-14.
What interventions are being tested in trial NCT04349917?
The interventions under investigation include: Placebo (OTHER), Methylphenidate (DRUG).
Who is sponsoring clinical trial NCT04349917?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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