CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 37 enrolled
Drug / intervention
Methylphenidate +1 moredrug
Likely dose
Methylphenidate 0.3 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04349917
NCT04349917Phase 4Completed

Large-scale Brain Organization During Cognitive Control in ADHD

University of North Carolina, Chapel Hill·interventional·Posted Apr 16, 2020·Updated Jan 12, 2021

In Brief

A Phase 4 clinical trial evaluating Methylphenidate and Placebo for Attention Deficit Hyperactivity Disorder. Completed, enrolled 37 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 16, 2020
Enrollment StartDec 16, 2016
Primary CompletionMar 14, 2020
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 6.2 years ago

Interventions

Methylphenidatedrug

A single, low dose of methylphenidate (0.3 mg/kg) will be administered on the drug day.

Placeboother

A matching placebo pill will be administered on the placebo day.