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

January 26, 2024 updated by: Johns Hopkins University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kristin L Bigos, PhD
  • Phone Number: 410-614-0453
  • Email: kbigos1@jhu.edu

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins School of Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methylphenidate first
Single oral dose of methylphenidate (10mg or 15 mg) and then matching placebo after washout period of one week.
Drug: Placebo
Matching placebo
Drug: Methylphenidate
single dose of 10 mg or 15 mg
Placebo Comparator: Placebo first
Matching placebo and then single oral dose of methylphenidate (10mg or 15 mg) after washout period of one week.
Drug: Placebo
Matching placebo
Drug: Methylphenidate
single dose of 10 mg or 15 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BOLD signal during response inhibition
Time Frame: Approximately 90 minutes after dose
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
Time Frame: Approximately 2 hours after dose
Glutamate level (measured by MRS, institutional units) in the anterior cingulate cortex.
Approximately 2 hours after dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Kristin L Bigos, PhD, Johns Hopkins School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2021

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 1, 2021

First Posted (Actual)

March 4, 2021

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00276357

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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