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

NCT ID: NCT04781972

Last Updated: 2025-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-27

Study Completion Date

2029-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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ADHD - Combined Type

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Methylphenidate first

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

Group Type EXPERIMENTAL

Methylphenidate

Intervention Type DRUG

single dose of 10 mg or 15 mg

Placebo

Intervention Type DRUG

Matching placebo

Placebo first

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

Group Type PLACEBO_COMPARATOR

Methylphenidate

Intervention Type DRUG

single dose of 10 mg or 15 mg

Placebo

Intervention Type DRUG

Matching placebo

Interventions

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Methylphenidate

single dose of 10 mg or 15 mg

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristin L Bigos, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

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Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kristin L Bigos, PhD

Role: CONTACT

410-614-0453

Robyn Wiseman, BS

Role: CONTACT

304-551-3309

Facility Contacts

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Kristin L Bigos, PhD

Role: primary

410-614-0453

Robyn L Wiseman, BS

Role: backup

3045513309

Other Identifiers

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IRB00276357

Identifier Type: -

Identifier Source: org_study_id

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