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NCT Number: NCT04781972

Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Patients With ADHD

The investigators' goal is to develop neuroimaging biomarkers to predict response to treatment with methylphenidate, which then can be used in the development of novel pharmacological treatments for attention-deficit/hyperactivity disorder (ADHD). The overall objective of this study is to measure the changes in task-related neural activity related to symptoms of ADHD (measured by functional MRI) and brain glutamate levels (measured by magnetic resonance spectroscopy, MRS) after treatment with methylphenidate (MPH). This will be a double-blind crossover of methylphenidate and placebo in adults with ADHD. Participants will complete neuropsychological testing along with fMRI and MRS scans after a single dose of each treatment.

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Key information

Conditions

ADHD - Combined Type

Age range

6 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • right handed

Exclusion criteria

  • pregnant or breast feeding
  • past or current neurological disorder
  • non-ADHD cause of cognitive impairment
  • uncontrolled medical disorder
  • head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma
  • having an adverse reaction to methylphenidate, or other stimulant medication
  • having a contraindication to MRI
  • current smoking

Treatment and study plan

Methylphenidate

Drug

single dose of 10 mg or 15 mg

Placebo

Drug

Matching placebo

Primary outcomes

  1. BOLD signal during response inhibition

    Time frame: Approximately 90 minutes after dose

    BOLD signal (brain activity during fMRI, arbitrary units) in the anterior cingulate cortex during response inhibition.

  2. Glutamate level in the anterior cingulate cortex

    Time frame: Approximately 2 hours after dose

    Glutamate level (measured by MRS, institutional units) in the anterior cingulate cortex.

Study contacts

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

Kristin L Bigos, PhD

CONTACT

[email protected]

410-614-0453

Robyn Wiseman, BS

CONTACT

[email protected]

304-551-3309

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2021
Primary completion
2028
Study completion
2029
First posted
Mar 4, 2021
Registry last updated
Oct 16, 2025

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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