Recruiting

Methylphenidate

Sponsor:

Johns Hopkins University

Code:

NCT04781972

Conditions

ADHD - Combined Type

Eligibility Criteria

Sex: All

Age: 6 - 40

Healthy Volunteers: Not accepted

Interventions

Methylphenidate

Placebo

Study Details

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.

Conditions

ADHD - Combined Type

Study ID

NCT04781972

Start date

Jul 27, 2021

Status verified date

Oct, 2025

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Methylphenidate first

Single oral dose of methylphenidate (10mg or 15 mg) and then matching placebo after washout period of one week.

placebo comparator: Placebo first

Matching placebo and then single oral dose of methylphenidate (10mg or 15 mg) after washout period of one week.

Interventions

Methylphenidate

single dose of 10 mg or 15 mg

Placebo

Matching placebo

Primary outcome measure

  • BOLD signal during response inhibition [ Time Frame: Approximately 90 minutes after dose ]
  • Glutamate level in the anterior cingulate cortex [ Time Frame: Approximately 2 hours after dose ]

Central Contacts and Locations

Central contacts

Kristin L Bigos, PhD

410-614-0453kbigos1@jhu.edu

Robyn Wiseman, BS

304-551-3309rwisema5@jhmi.edu

Locations

Johns Hopkins School of Medicine

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Kristin L Bigos, PhD

410-614-0453kbigos1@jhu.edu

Robyn L Wiseman, BS

3045513309rwisema5@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Oct 16, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-10-16.