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

ADHD - Combined Type Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04781972
• Other study ID #: IRB00276357
• Status: Recruiting
• Phase: Phase 4
• Start date: July 27, 2021
• Est. completion date: May 1, 2025

Study information

• Verified date: May 2024
• Source: Johns Hopkins University
• Contact: Kristin L Bigos, PhD
• Phone: 410-614-0453
• Email: kbigos1[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD - Combined Type

Intervention

Drug:
• Methylphenidate
single dose of 10 mg or 15 mg
• Placebo
Matching placebo

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Glutamate level in the anterior cingulate cortex	Glutamate level (measured by MRS, institutional units) in the anterior cingulate cortex.	Approximately 2 hours after dose