Actively Recruiting

Phase 4
Age: 6Years - 40Years
All Genders
ID04781972

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

Led by Johns Hopkins University · Updated on 2025-10-16

30

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how brain imaging can help predict responses to treatment with methylphenidate in people with combined-type attention-deficit/hyperactivity disorder (ADHD). The study aims to measure changes in brain activity during tasks and brain glutamate levels after treatment, helping guide the development of new ADHD medications. This is a phase 4 trial involving adults with ADHD. Participants receive a single oral dose of either methylphenidate (10 mg or 15 mg) or a matching placebo, followed by the alternate treatment after a one-week washout period. This double-blind crossover design means that neither participants nor researchers know the order of treatments during the study. The effects of each dose will be assessed with brain scans and testing. During the study, participants will undergo neuropsychological testing along with functional MRI and magnetic resonance spectroscopy scans to measure brain activity and glutamate levels approximately 90 minutes to 2 hours after dosing. Researchers will monitor brain responses related to symptom control and medication effects. The total participation includes two treatment sessions separated by a washout period, with detailed brain imaging and assessments at each visit.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 6Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Right handed
  • Age between 6 and 40 years
  • Diagnosed with combined-type ADHD
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Past or current neurological disorder
  • Cognitive impairment not caused by ADHD
  • Uncontrolled medical disorder
  • Head trauma with loss of consciousness in the past year or ongoing impairment from head trauma
  • Adverse reaction to methylphenidate or other stimulants
  • Contraindication to MRI
  • Current smoking

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 3 weeks including washout

Participants receive a single oral dose of methylphenidate (10 mg or 15 mg) and matching placebo in a randomized crossover design separated by a one-week washout period.

2 visits (in-person) separated by one week

Trial Site Locations

Total: 1 location

1

Johns Hopkins School of Medicine

Baltimore, Maryland, United States, 21205

Actively Recruiting

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Research Team

K

Kristin L Bigos, PhD

R

Robyn Wiseman, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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