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

Phase 4

Recruiting

• Conditions: ADHD - Combined Type
• Interventions: Drug: Methylphenidate; Drug: Placebo

• Registration Number: NCT04781972
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-04
• Study Start: 2021-07-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-08
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo first	Placebo	Matching placebo and then single oral dose of methylphenidate (10mg or 15 mg) after washout period of one week.
Methylphenidate first	Placebo	Single oral dose of methylphenidate (10mg or 15 mg) and then matching placebo after washout period of one week.
Methylphenidate first	Methylphenidate	Single oral dose of methylphenidate (10mg or 15 mg) and then matching placebo after washout period of one week.
Placebo first	Methylphenidate	Matching placebo and then single oral dose of methylphenidate (10mg or 15 mg) after washout period of one week.

Primary Outcome Measures

Name	Time	Method
BOLD signal during response inhibition	Approximately 90 minutes after dose	BOLD signal (brain activity during fMRI, arbitrary units) in the anterior cingulate cortex during response inhibition.
Glutamate level in the anterior cingulate cortex	Approximately 2 hours after dose	Glutamate level (measured by MRS, institutional units) in the anterior cingulate cortex.

Trial Locations

Locations (1)

Johns Hopkins School of Medicine; 🇺🇸 Baltimore, Maryland, United States