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

NCT04781972 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB00276357
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• BOLD signal during response inhibition

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

  Approximately 90 minutes after dose

• Glutamate level in the anterior cingulate cortex

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

  Approximately 2 hours after dose

Study Arms (2)

Methylphenidate first

EXPERIMENTAL

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

Drug: Methylphenidate; Drug: Placebo

Placebo first

PLACEBO COMPARATOR

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

Drug: Methylphenidate; Drug: Placebo

Interventions

Methylphenidate DRUG

single dose of 10 mg or 15 mg

Methylphenidate first; Placebo first

Placebo DRUG

Matching placebo

Methylphenidate first; Placebo first

Eligibility Criteria

• Age: 6 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• right handed

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Interventions

Methylphenidate

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kristin L Bigos, PhD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin L Bigos, PhD

CONTACT

410-614-0453; kbigos1@jhu.edu

Robyn Wiseman, BS

CONTACT

304-551-3309; rwisema5@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 4, 2021
• Study Start: July 27, 2021
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)