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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT04781972
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • ADHD - Combined Type

Eligibility Criteria

Sex
ALL
Age
6 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Methylphenidate — DRUG
    single dose of 10 mg or 15 mg
  • Placebo — DRUG
    Matching placebo

Study Details

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.

Key Dates

Start date
Jul 27, 2021
Status verified
Oct 2025
Primary completion
Nov 30, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Methylphenidate first
    Single oral dose of methylphenidate (10mg or 15 mg) and then matching placebo after washout period of one week.
  • Placebo Comparator: Placebo first
    Matching placebo and then single oral dose of methylphenidate (10mg or 15 mg) after washout period of one week.

Primary Outcome Measure

BOLD signal during response inhibition [ Time Frame: Approximately 90 minutes after dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins School of MedicineBaltimoreMaryland21205
Kristin L Bigos, PhD
[email protected]
410-614-0453
Robyn L Wiseman, BS
[email protected]
3045513309

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