Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Patients With ADHD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methylphenidate, Placebo.
- Who it may be relevant to
- Registry conditions: ADHD - Combined Type. Basic parameters: 6 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Methylphenidate
single dose of 10 mg or 15 mg - Drug Placebo
Matching placebo
Primary outcome measures
- BOLD signal during response inhibition [Time frame: Approximately 90 minutes after dose]
- Glutamate level in the anterior cingulate cortex [Time frame: Approximately 2 hours after dose]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Johns Hopkins School of Medicine — Baltimore
Identifiers
NCT: NCT04781972 · IRB00276357