ADHDPhase 4NCT06077669
Multimodal Brain Imaging of Methylphenidate in Children and Adolescents With ADHD
A Phase 4 study testing Methylphenidate in people with ADHD, run by Johns Hopkins University at 1 site in United States.
Trial summary
The goal of this proposal is to develop brain imaging tools to measure the effects of methylphenidate in children and adolescents with attention deficit hyperactivity disorder (ADHD). Methylphenidate is an FDA-approved treatment for ADHD. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- ADHD
- 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2024to Jan 2029
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 6 to 18 years
- Diagnosis of ADHD
- A score of at least 3 (mildly ill) on the clinician administered Clinical Global Impressions-Severity (CGI-S)
Who cannot join
- Currently taking stimulant medications (within one week of first study visit). Patients will not be asked to discontinue any treatments for the purpose of this research study. Subjects will include treatment naïve patients and patients who were previously treated with stimulant medications, but are not currently treated, and meet study criteria.
- Having an adverse reaction to methylphenidate, or other stimulant medication
- Current psychiatric disorder, including bipolar I or II disorder, major depressive, disorder, obsessive-compulsive disorder, autism spectrum disorder, Tourette syndrome, or history of psychosis
- Patient is at risk for clinically significant deterioration due to study protocol, as assessed by primary medical investigator (Dr. Grant)
- Confirmed genetic disorder with cognitive and/or behavioral disturbances
- Active, unstable medical illness that may interfere with cognition or compromises safety of the patient
Show all 11Show fewer
- History of head trauma with loss of consciousness or any evidence of functional impairment due to, and persisting after, head trauma
- Neurological disorder, mental retardation, intellectual or disability, or other non-ADHD cause of cognitive impairment
- Pregnant or breast-feeding women
- Having a contraindication to MRI, including a pacemaker, defibrillator or other medical implant, other metal objects, or claustrophobia, or for having braces or other metal in the head region (likely to create an artifact on the MRI scans).
- Currently smoking or using controlled or illicit substances, including alcohol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
About this study
Official title: Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Children and Adolescents With ADHD
The goal of this proposal is to develop brain imaging tools to measure the effects of methylphenidate in children and adolescents with attention deficit hyperactivity disorder (ADHD). Methylphenidate is an FDA-approved treatment for ADHD. Specifically, the investigators will correlate brain activity during cognitive tasks and brain chemistry with cognitive performance. These measures could help the investigators understand how current ADHD medications work and then could be used to develop novel drugs to treat ADHD in children and adolescents.
- Conditions
- ADHD
- Being tested
- Methylphenidate, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called Ritalin
Single oral dose of methylphenidate (5mg or 10 mg)
PlaceboDrug
oral placebo
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate - low dose | Experimental | 5 mg of methylphenidate Receives: Drug: Methylphenidate |
| Methylphenidate - high dose | Experimental | 10 mg of methylphenidate Receives: Drug: Methylphenidate |
| Placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD signal during response inhibition
Blood oxygenation level dependent (BOLD) signal (brain activity during functional magnetic resonance imaging (fMRI), arbitrary units) in the anterior cingulate cortex during response inhibition.
Measured: Approximately 90 minutes after dose
BOLD signal during working memory
BOLD signal (brain activity during fMRI, arbitrary units) in the frontal cortex during working memory
Measured: Approximately 90 minutes after dose
Glutamate level in the anterior cingulate cortex
Glutamate level (measured by magnetic resonance spectroscopy (MRS), institutional units) in the anterior cingulate cortex (ACC).
Measured: Approximately 2 hours after dose
Glutamate level in the dorsolateral prefrontal cortex
Glutamate level (measured by MRS, institutional units) in the dorsolateral prefrontal cortex
Measured: Approximately 2 hours after dose
Cognitive performance as assessed by the Flanker performance task
NIH Toolbox Cognitive Battery Flanker task, score range 0 to 20, higher score is better performance
Measured: Approximately 3 hours after dose
Working memory performance
NIH Toolbox Cognitive Battery working memory task (list sorting), score range 0 to 26, higher score is better performance
Measured: Approximately 3 hours after dose
Secondary outcomes (3)
ADHD as assessed by the Connors 3
Connors 3rd edition ADHD assessment, lower score means less symptoms, typical scores are 40 to 59, above 65 is an elevated score (meaning more concerns than are typically reported)
Measured: At each study visit, approximately 3 hours after dose
NIH Toolbox Cognitive Battery
Cognition Fluid Composite, Cognition Crystallized Composite, Cognition Total Composite Score, and other individual test scores
Measured: Approximately 3 hours after dose
Methylphenidate plasma levels
Methylphenidate plasma levels will be drawn before and after brain imaging on each visit
Measured: Approximately 90 min and 150 min after dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start16 Apr 2024 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJan 2029 (estimated)
Why it stopped: Study withdrawn in IRB by PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin Bigos, PhD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077669
- Sponsor's protocol ID
- IRB00408678
- Status last verified
- Mar 2024
- First submitted
- 5 Oct 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be deposited in the National Institute of Mental Health Data Archive (NDA) will be collected for each subject. All raw and processed phenotypic data (clinical, cognitive, imaging) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. 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 Children and Adolescents With ADHD
- ClinicalTrials.gov ID
- NCT06077669
- Acronym / sponsor ID
- IRB00408678
- Conditions
- ADHD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn in IRB by PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 16 Apr 2024 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 11 Oct 2023 (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 goal of this proposal is to develop brain imaging tools to measure the effects of methylphenidate in children and adolescents with attention deficit hyperactivity disorder (ADHD). Methylphenidate is an FDA-approved treatment for ADHD. Specifically, the investigators will correlate brain activity during cognitive tasks and brain chemistry with cognitive performance. These measures could help the investigators understand how current ADHD medications work and then could be used to develop novel drugs to treat ADHD in children and adolescents.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate - low dose | Experimental | Drug: Methylphenidate5 mg of methylphenidate |
| Methylphenidate - high dose | Experimental | Drug: Methylphenidate10 mg of methylphenidate |
| Placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 6 to 18 years
- Diagnosis of ADHD
- A score of at least 3 (mildly ill) on the clinician administered Clinical Global Impressions-Severity (CGI-S)
Key exclusion criteria (11 listed)
- Currently taking stimulant medications (within one week of first study visit). Patients will not be asked to discontinue any treatments for the purpose of this research study. Subjects will include treatment naïve patients and patients who were previously treated with stimulant medications, but are not currently treated, and meet study criteria.
- Having an adverse reaction to methylphenidate, or other stimulant medication
- Current psychiatric disorder, including bipolar I or II disorder, major depressive, disorder, obsessive-compulsive disorder, autism spectrum disorder, Tourette syndrome, or history of psychosis
- Patient is at risk for clinically significant deterioration due to study protocol, as assessed by primary medical investigator (Dr. Grant)
- Confirmed genetic disorder with cognitive and/or behavioral disturbances
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 |
|---|---|---|
| MethylphenidateAlso: RitalinSingle oral dose of methylphenidate (5mg or 10 mg) | Drug | Methylphenidate - high dose, Methylphenidate - low dose |
| Placebooral placebo | Drug | Placebo |
Primary outcome
BOLD signal during response inhibition
Time frame: Approximately 90 minutes after dose
Blood oxygenation level dependent (BOLD) signal (brain activity during functional magnetic resonance imaging (fMRI), arbitrary units) in the anterior cingulate cortex during response inhibition.
BOLD signal during working memory
Time frame: Approximately 90 minutes after dose
BOLD signal (brain activity during fMRI, arbitrary units) in the frontal cortex during working memory
Glutamate level in the anterior cingulate cortex
Time frame: Approximately 2 hours after dose
Glutamate level (measured by magnetic resonance spectroscopy (MRS), institutional units) in the anterior cingulate cortex (ACC).
Glutamate level in the dorsolateral prefrontal cortex
Time frame: Approximately 2 hours after dose
Glutamate level (measured by MRS, institutional units) in the dorsolateral prefrontal cortex
Cognitive performance as assessed by the Flanker performance task
Time frame: Approximately 3 hours after dose
NIH Toolbox Cognitive Battery Flanker task, score range 0 to 20, higher score is better performance
Working memory performance
Time frame: Approximately 3 hours after dose
NIH Toolbox Cognitive Battery working memory task (list sorting), score range 0 to 26, higher score is better performance
3 secondary outcomes
ADHD as assessed by the Connors 3
Time frame: At each study visit, approximately 3 hours after dose
NIH Toolbox Cognitive Battery
Time frame: Approximately 3 hours after dose
Methylphenidate plasma levels
Time frame: Approximately 90 min and 150 min after dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Yes. De-identified data will be deposited in the National Institute of Mental Health Data Archive (NDA) will be collected for each subject. All raw and processed phenotypic data (clinical, cognitive, imaging) will be shared.
Related trials for ADHD
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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. This study is not recruiting at the moment.
Kristin 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, 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 3 inclusion and 11 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: withdrawn, as of the sponsor's last update on 15 Mar 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 6 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 15 Mar 2024.