drugset
drugset / Trial / NCT04349917

Large-scale Brain Organization During Cognitive Control in ADHD

NCT04349917 ↗

Phase 4 Completed 37 enrolled University of North Carolina, Chapel Hill National Institute of Mental Health (NIMH) · collab
RandomizedCrossoverDouble-blindBasic science

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.

Timeline

Start
2016-12-16
Primary completion
2020-03-14
Completion
2020-03-14

Outcome

Mixed primary results

registry analysis (superiority test); Methylphenidate vs Placebo; p = 0.532; t-test, 2 sided NCT04349917 ↗

registry analysis (superiority test); Methylphenidate vs Placebo; p = 0.579; t-test, 2 sided NCT04349917 ↗

registry MEAN Methylphenidate: GNG reward: 0.235 (Standard Deviation 0.051) units on a scale NCT04349917 ↗

registry MEAN Placebo: GNG reward: 0.213 (Standard Deviation 0.055) units on a scale NCT04349917 ↗

registry analysis (superiority test); Methylphenidate vs Placebo; p = 0.034; t-test, 2 sided NCT04349917 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Methylphenidate Small molecule 0.3 mg/kg —

Indications

attention deficit-hyperactivity disorder