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NCT Number: NCT05600881

Towards an Understanding of the Mechanism of Action of Methylphenidate in ADHD

Approximately 1-in-20 children worldwide have Attention Deficit Hyperactivity Disorder (ADHD), a condition associated with disabling inattention, hyperactivity and impulsivity. These problems can manifest as poor inhibitory control (e.g., difficulty holding back impulsive actions) and atypical reward processing (e.g., failing to learn from adverse outcomes). Poorly treated ADHD is associated with negative academic and socioeconomic consequences.

This project aims to ultimately improve clinical management of children with ADHD. Methylphenidate, a stimulant medication, is used as the first-option pharmacological treatment for ADHD and often successfully reduces problem behaviour. Although Methylphenidate can be extremely effective, it does not work for every child. There is currently no 'objective' way (e.g., blood test or brain scan) to measure if a child is genuinely responding to Methylphenidate. Instead, clinicians must rely on reports from parents and teachers, an approach that is problematic and that often leads to delays in optimising ADHD treatment. The absence of a biological test to quantify Methylphenidate response is primarily because we do not understand exactly how Methylphenidate changes behaviours to produce the known beneficial effects. This lack of knowledge is despite the very common use of this medication.

This project will investigate the specific brain processes that are affected by Methylphenidate by recording brain activity and behaviour in children with ADHD (who have already been prescribed Methylphenidate as part of their clinical care) when they are on and off this medication. Brain activity will be recorded using two separate approaches, which are both non-invasive and routinely used in Trinity College Institute of Neuroscience: electroencephalography (EEG) and functional magnetic resonance imaging (fMRI). Brain activity data will be collected while children with ADHD are performing two computer-game like tasks. One task measures the child's ability to hold back impulsive actions (inhibition) and the other assesses how they learn from positive and negative outcomes (reward processing). The data from the two tasks, the EEG recording and the fMRI scan will be analysed using advanced computer-modelling approaches to determine exactly how Methylphenidate changes behaviour.

This project is important because if we can understand the brain mechanisms affected by Methylphenidate, we can ultimately develop a computerised measure that will allow clinicians to predict whether a child is going to respond to this treatment or not. Such a measure would allow clinicians to treat ADHD more effectively and would result in children with ADHD experiencing faster relief from symptoms.

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Key information

About this study

This project will investigate the specific brain processes that are affected by Methylphenidate by recording brain activity and behaviour in children with ADHD (who have already been prescribed Methylphenidate as part of their clinical care) when they are on and off this medication.

This is a quantitative double-blind placebo-controlled study investigating the acute effects of methylphenidate on brain activity using two non-invasive methods, EEG and fMRI.

Brain activity will be recorded using two separate approaches, which are both non-invasive and routinely used in Trinity College Institute of Neuroscience: electroencephalography (EEG) and functional magnetic resonance imaging (fMRI). Brain activity data will be collected while children with ADHD are performing two computer-game like tasks. One task measures the child's ability to hold back impulsive actions (inhibition) and the other assesses how they learn from positive and negative outcomes (reward processing). The data from the two tasks, the EEG recording, and the fMRI scan will be analysed using advanced computer-modelling approaches to determine exactly how Methylphenidate changes behaviour.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

AFAB Clinical diagnosis of ADHD Must be able to swallow tablets Regular menstrual cycles Good response to medication

Exclusion criteria

Intellectual Disability Specific Learning Disabilities

Treatment and study plan

Methylphenidate

Drug

Participants will take their regular medication or a placebo (vitamin C)

Primary outcomes

  1. MRI

    Time frame: 2023-2026

    structural, diffusion, functional

Secondary outcomes

  1. Stop Signal Task

    Time frame: 2023-2026

    behavioural measures

Other outcomes

  1. EEG

    Time frame: 2023-2026

    during SST

Study contacts

Contact information is provided by the study sponsor or research team.

Julia Paterson, BSc, BCompSci

CONTACT

[email protected]

0896164340

Sponsors and collaborators

Lead sponsor

University of Dublin, Trinity College

Other

Collaborators

  • St. James's Hospital, Ireland

Registry information

Official study title

Understanding the Mechanism of Action of Methylphenidate in ADHD: A Computational Psychiatry Approach

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 1, 2022
Registry last updated
May 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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