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Clinical Trials/NCT04781972
NCT04781972
Recruiting
Phase 4

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

Johns Hopkins University1 site in 1 country30 target enrollmentJuly 27, 2021

Overview

Phase
Phase 4
Intervention
Methylphenidate
Conditions
ADHD - Combined Type
Sponsor
Johns Hopkins University
Enrollment
30
Locations
1
Primary Endpoint
BOLD signal during response inhibition
Status
Recruiting
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 27, 2021
End Date
April 30, 2029
Last Updated
6 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Methylphenidate first

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

Intervention: Methylphenidate

Methylphenidate first

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

Intervention: Placebo

Placebo first

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

Intervention: Methylphenidate

Placebo first

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

Intervention: Placebo

Outcomes

Primary Outcomes

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.

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.

Study Sites (1)

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