Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Patients With ADHD
ConditionADHD - Combined Type
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-40
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
right handed
Disqualifiers
pregnant or breast feeding
past or current neurological disorder
non-ADHD cause of cognitive impairment
uncontrolled medical disorder
Trial design
Design model
Crossover
Treatments tested in this trial
Methylphenidate
Drugsingle dose of 10 mg or 15 mg
Placebo
DrugMatching placebo
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Methylphenidate firstExperimental treatment 2 interventions
Group B: Placebo firstPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
BOLD signal during response inhibition
BOLD signal (brain activity during fMRI, arbitrary units) in the anterior cingulate cortex during response inhibition.
Time frame
Approximately 90 minutes after dose2
Glutamate level in the anterior cingulate cortex
Glutamate level (measured by MRS, institutional units) in the anterior cingulate cortex.
Time frame
Approximately 2 hours after doseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov