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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04781972
Other study ID # IRB00276357
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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