Skip to content

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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04781972
Enrollment
30
Registered
2021-03-04
Start date
2021-07-27
Completion date
2029-04-30
Last updated
2025-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD - Combined Type

Brief summary

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.

Interventions

DRUGMethylphenidate

single dose of 10 mg or 15 mg

DRUGPlacebo

Matching placebo

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Intervention model description

This is a double-blind cross over of a single dose of methylphenidate (10mg or 15mg) and matching placebo.

Eligibility

Sex/Gender
ALL
Age
6 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
BOLD signal during response inhibitionApproximately 90 minutes after doseBOLD signal (brain activity during fMRI, arbitrary units) in the anterior cingulate cortex during response inhibition.
Glutamate level in the anterior cingulate cortexApproximately 2 hours after doseGlutamate level (measured by MRS, institutional units) in the anterior cingulate cortex.

Countries

United States

Contacts

Primary ContactKristin L Bigos, PhD
kbigos1@jhu.edu410-614-0453
Backup ContactRobyn Wiseman, BS
rwisema5@jhmi.edu304-551-3309

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026