Large-scale Brain Organization During Cognitive Control in ADHD

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-16

Study Completion Date

2020-03-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, double-blind, placebo-controlled, crossover design. Each subject with ADHD participates in two sessions, one on drug and one on placebo (order randomized ). Both subjects and experimenters are blind to the order.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

The pharmacy that provides the drug/placebo works from a randomized subject order defining whether each subject received drug first or placebo first. Only the pharmacists know this order, and the drug and placebo look identical to the participants and the investigators.

Study Groups

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Placebo, then Methylphenidate

All children with ADHD in this study will receive one dose of methylphenidate and one dose of placebo over the course of two sessions approximately one week apart (order randomized and double-blind).

Group Type PLACEBO_COMPARATOR

Methylphenidate

Intervention Type DRUG

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

Placebo

Intervention Type OTHER

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

Methylphenidate, then Placebo

All children with ADHD in this study will receive one dose of methylphenidate and one dose of placebo over the course of two sessions approximately one week apart (order randomized and double-blind).

Group Type EXPERIMENTAL

Methylphenidate

Intervention Type DRUG

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

Placebo

Intervention Type OTHER

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

Interventions

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Methylphenidate

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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Ritalin Sugar pill

Eligibility Criteria

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Inclusion Criteria

* Between 8-12 years old
* Diagnosis of ADHD (for ADHD group); ADHD group only can have comorbid Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnoses of oppositional defiant disorder, conduct disorder, depressive disorders, or anxiety disorders
* ADHD subjects must never have been treated with medication for their ADHD

Exclusion Criteria

* Wechsler Intelligence Scale for Children-Fifth Edition Full-Scale Intelligence Quotient (IQ) \< 80
* Wechsler Individual Achievement Test-Third Edition Word Reading \< 85
* Any neurologic or developmental disabilities
* Any reading or learning disabilities
* Visual impairment that cannot be corrected-to-normal
* Color blindness
* Documented hearing impairment greater than 25 decibels (dB) loss in either year
* Have already gone through puberty (Tanner Stage II or higher)
* Medical contraindication to MRI
* Any psychoactive medication

Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No