ADHD - Combined TypePhase 4NCT04781972
Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Patients With ADHD
A Phase 4 study testing Methylphenidate in people with ADHD - Combined Type, run by Johns Hopkins University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 40 years
- Conditions the study is for
- ADHD - Combined Type
- What is being tested?
- Methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2021to 30 Apr 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- right handed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
Kristin L Bigos, PhD, 410-614-0453, kbigos1@jhu.edu
Robyn L Wiseman, BS, 3045513309, rwisema5@jhmi.edu
About this study
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.
- Conditions
- ADHD - Combined Type
- Being tested
- Methylphenidate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
single dose of 10 mg or 15 mg
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate first | Experimental | Single oral dose of methylphenidate (10mg or 15 mg) and then matching placebo after washout period of one week. Receives: Drug: Methylphenidate; Drug: Placebo |
| Placebo first | Placebo comparator | Matching placebo and then single oral dose of methylphenidate (10mg or 15 mg) after washout period of one week. Receives: Drug: Methylphenidate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD signal during response inhibition
BOLD signal (brain activity during fMRI, arbitrary units) in the anterior cingulate cortex during response inhibition.
Measured: Approximately 90 minutes after dose
Glutamate level in the anterior cingulate cortex
Glutamate level (measured by MRS, institutional units) in the anterior cingulate cortex.
Measured: Approximately 2 hours after dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start27 Jul 2021
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHD - Combined TypeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a double-blind cross over of a single dose of methylphenidate (10mg or 15mg) and matching placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Kristin L Bigos, PhD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781972
- Sponsor's protocol ID
- IRB00276357
- Status last verified
- Oct 2026
- First submitted
- 1 Mar 2021
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Patients With ADHD
- ClinicalTrials.gov ID
- NCT04781972
- Acronym / sponsor ID
- IRB00276357
- Conditions
- ADHD - Combined Type
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a double-blind cross over of a single dose of methylphenidate (10mg or 15mg) and matching placebo.
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate first | Experimental | Drug: Methylphenidate, Drug: PlaceboSingle oral dose of methylphenidate (10mg or 15 mg) and then matching placebo after washout period of one week. |
| Placebo first | Placebo comparator | Drug: Methylphenidate, Drug: PlaceboMatching placebo and then single oral dose of methylphenidate (10mg or 15 mg) after washout period of one week. |
Who may qualify
- Ages
- 6 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- right handed
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylphenidatesingle dose of 10 mg or 15 mg | Drug | Methylphenidate first, Placebo first |
| PlaceboMatching placebo | Drug | Methylphenidate first, Placebo first |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristin L Bigos, PhD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate in people with ADHD - Combined Type, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristin L Bigos, PhD (410-614-0453, kbigos1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD signal during response inhibition (time frame: Approximately 90 minutes after dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.