Attention Deficit Hyperactivity Disorder CombinedPhase 4AMPAIIINCT04421248
Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder
A Phase 4 study testing Methylphenidate in people with Attention Deficit Hyperactivity Disorder Combined, run by Donald Gilbert, MD, MS, FAAN, FAAP at 2 sites in United States.
Trial summary
Attention-Deficit/Hyperactivity Disorder (ADHD) is the most commonly diagnosed neurobehavioral disorder in childhood. Children with ADHD struggle in school due to problems with attention and high levels of impulsivity and hyperactivity. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder Combined
- What is being tested?
- Methylphenidate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2020to 1 Mar 2027
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Either gender, any race, ethnicity or socioeconomic status
- Currently between 8 years 0 months and 12 years, 11 months, 30 days
- Willing to answer questions about ADHD and related diagnoses
- For children with ADHD prescribed stimulant medications, willing to suspend taking medications as specified in the study procedures
- For children with ADHD, willing to participate in the single dose, randomized crossover study to probe acute effects of methylphenidate on biomarkers
- Right hand dominant (predominately right-handed)
Show all 9Show fewer
- Able to participate in and sign an informed consent
- ADHD inclusion: The diagnosis of ADHD will be based on Diagnostic and Statistical Manual version 5 (DSM-5) criteria using standard rating scales and a structured diagnostic interview. Oppositional Defiant Disorder is permitted; Conduct disorder is excluded.
- Typically Developing (healthy control) inclusion: Free of ADHD or other developmental or psychiatric disorders based on DSM-5 criteria using standard rating scales and a structured diagnostic interview.
Who cannot join
- Known diagnosis of mental retardation, cerebral palsy, Autism Spectrum Disorder, traumatic brain injury, brain tumor, epilepsy, or other serious neurological disorder.
- Major Depression, Bipolar Disorder, Conduct Disorder, Adjustment Disorder, other Anxiety Disorders, or other developmental psychiatric diagnoses.
- For females, onset of menses, pregnancy.
- Current use of antidepressants, non-stimulant ADHD medications, dopamine blocking agents, mood stabilizers.
- Implanted brain stimulator, vagal nerve stimulator, ventriculo-peritoneal shunt, cardiac pacemaker, or implanted medication port.
- Diagnosis of a speech/language disorder or a Reading Disability (RD).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Alyssa DeRonda, 443-923-9528, deronda@kennedykrieger.org
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Karlee Migneault, 513-803-2670, karlee.migneault@cchmc.org
About this study
Official title: Anomalous Motor System Physiology in Attention Deficit Hyperactivity Disorder: Biomarker Validation and Modeling Domains of Function
Attention-Deficit/Hyperactivity Disorder (ADHD) is the most commonly diagnosed neurobehavioral disorder in childhood. Children with ADHD struggle in school due to problems with attention and high levels of impulsivity and hyperactivity. They are at substantially increased risk for long-term difficulties into adulthood, including academic underachievement, substance abuse, and criminal behavior. The diagnosis of ADHD, which is based on subjective ratings by parents and teachers, likely results from multiple different, overlapping differences in circuits of the brain responsible for attention and impulse control. However, we do not have any scientific or clinical tests that allow us to understand these circuits. In an effort to improve ADHD outcomes, we have used a technology called Transcranial Magnetic Stimulation (TMS) to identify highly reliable measurements of brain function. We have identified two very promising measures that are abnormal in children with ADHD and, importantly, also predict the severity of ADHD behaviors. The goal of this project is to determine if these two TMS measurements could be used to help better guide ADHD treatment. To do this, we will perform three investigations in 8 to 12 year old children to determine: 1) test-retest reliability; 2) pharmacologic responsiveness; and 3) correlations with two domains of function relevant to ADHD: "Cognitive Control" and "Emotional Valence." Through these investigations, we aim to determine whether these two TMS brain measures are reliable and meaningful enough to be used to help improve precision of individually-targeted and effective ADHD treatments.
Read the detailed description
4.2. NARRATIVE STUDY DESCRIPTION
Summary This is a randomized, blinded, placebo-controlled, single-dose crossover study. The objective is to estimate, in a rigorous, unbiased manner, the effect of 10 mg methylphenidate (MPH) on two putative biomarkers of ADHD, measured using Transcranial Magnetic Stimulation (TMS). Two other aims of this larger study, quantifying test-retest reliability and linking TMS biomarkers to RDoC domains of cognitive control and emotional valence, are not directly part of the clinical trial and are fully described in the research strategy.
Doctors use observations and subjective rating scales both to diagnose Attention Deficit Hyperactivity Disorder (ADHD) and to make decisions about medical or behavioral treatments. This study addresses the possibility that in children with ADHD, brain-based measurements, or biomarkers, could be useful for diagnosis and treatment decisions. These biomarkers are Short Interval Cortical Inhibition (SICI) and Task-Related Up-Modulation (TRUM). These biomarkers may allow clinicians to identify that a child has a "type" of ADHD which might respond more effectively to treatments that are precisely and individually targeted. Thus it is important to estimate the effects of commonly prescribed treatments on SICI and TRUM. This protocol aims to determine the effects of a single 10 mg dose of MPH, a stimulant medication widely prescribed to treat ADHD, on SICI and TRUM.
Assignment of participants For each child with ADHD, participation in the study will consist of three visits. Treatment occurs as a single dose on visits 2 and 3. All participants will receive both placebo and 10 mg MPH. Order will be counterbalanced.
Population Sample At the two study sites, Cincinnati Children's Hospital Medical Center (CCHMC) and the Kennedy Krieger Institute (KKI), we will recruit 144 pre-pubescent children, ages 8 years 0 months to 12 years 11 months, with ADHD. We estimate a total of 120 participants will participate in the full study. All recruitment methods will conform to CCHMC Institutional Review Board (IRB) and HIPAA requirements. The study will be approved by the CCHMC Institutional IRB. Children with ADHD will be primarily recruited through community resources, including local chapters of the Children with ADHD (CHADD), local public and private schools, as well as multiple clinics at CCHMC and KKI.
Study Flow During the first study visit, participants will provide informed consent. They will then complete diagnostic and psychoeducational testing. The parent/guardian will complete standardized questionnaires and a comprehensive psychiatric diagnostic interview with a trained and research reliable psychology associate under the supervision of a neuropsychologist at each site.
At visit 1: if determined to be eligible to continue, visits 2 and 3 will be scheduled at 2-week intervals.
At visit 2: participant will undergo pre-dose TMS for measures of SICI and TRUM, receive either MPH or placebo, then undergo post-dose TMS.
At visit 3: participant will undergo pre-dose TMS measures of SICI and TRUM (test/re-test assessment), receive the opposite treatment of either MPH or placebo, then undergo post-dose TMS.
Intervention - MPH versus Placebo Procedures
The MPH and the placebo will be prepared by the study pharmacy at each site so that they appear identical. Neither the child, the parent, nor the investigators will know which treatment is given. The study pharmacy will randomize children into two groups, without disclosing this information to the researchers or participants. Group 1 will receive MPH on the first treatment visit (visit 2 of the study) and placebo the second. Group 2 will receive placebo on the first treatment visit and MPH the second.
Note: for comparison and validation of the study measures, 70 children who are typically developing and do not have ADHD will also be enrolled. These control participants will not receive methylphenidate or placebo, however.
- Being tested
- Methylphenidate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called Ritalin
In ADHD participants only: blinded, randomized, placebo-controlled single dose, crossover on separate days separated by at least one week.
PlaceboDrug
In ADHD participants only: blinded, randomized, placebo-controlled, single dose, crossover on separate days separated by at least one week.
| Study group | Role | What they receive |
|---|---|---|
| Attention Deficit Hyperactivity Disorder (ADHD) | Experimental | 8 to 12 year old children diagnosed with ADHD. Randomized, blinded, single dose, placebo controlled, crossover trial. Receives: Drug: Methylphenidate; Drug: Placebo |
| Typically developing controls (TDC) | No intervention | Typically developing controls - 8 to 12 year old children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcranial Magnetic Stimulation (TMS)-evoked Short Interval Cortical Inhibition (SICI) Test-Retest Reliability
A ratio of amplitudes of motor evoked potentials from paired (inhibitory) and single TMS pulses, obtained from dominant motor cortex with hand at rest
Measured: less than one month
Transcranial Magnetic Stimulation (TMS)-evoked Task Related Up Modulation (TRUM) Test-Retest Reliability
A ratio of amplitudes of motor evoked potentials during engagement in a response inhibition task versus rest, obtained from dominant motor cortex
Measured: less than one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Sep 2020
- Primary completion9 Feb 2026
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder CombinedStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, blinded, placebo-controlled, single-dose crossover study. The objective is to estimate, in a rigorous, unbiased manner, the effect of 10 mg methylphenidate (MPH) on two putative biomarkers of ADHD, measured using Transcranial Magnetic Stimulation (TMS). Outcomes will be evaluated via repeated measures, mixed model analysis with MEP amplitude as the dependent variable and Treatment and Treatment-Sequence as class variables. Participants will include 144 children with ADHD. Study measures will also be compared in 70 matched, typically developing children who do not have ADHD and who will not receive methylphenidate or placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Donald Gilbert, MD, MS, FAAN, FAAP
- Sponsor type
- University, hospital or other
- Collaborators
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Responsible party
- Sponsor-investigator, Donald Gilbert, MD, MS, FAAN, FAAP, Children's Hospital Medical Center, Cincinnati
- Investigators
- Donald L Gilbert, MD, Principal investigator, Children's Hospital Medical Center, CincinnatiStewart H Mostofsky, MD, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421248
- Sponsor's protocol ID
- CHMC IRB 2020-0297
- Acronym
- AMPAIII
- Status last verified
- May 2026
- First submitted
- 4 Jun 2020
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of individual participant data (IPD) will occur through the National Institute of Mental Health (NIMH) Data Archive, consistent with the NIMH Data Sharing Policy. This includes all raw and analyzed data, including clinical, phenotypic, and neurophysiological biomarker data, which will be de-identified and deposited in the NIMH Data Archive (NDA). Data from research subjects will include Required Data Elements: 1) NDA Global Unique Identifier assigned to participants (GUID); 2) the study's internal subject identifier (Src\_subject\_id); 3) interview age in months (interview\_age); 4) data collection date (interview\_date); and 5) birth sex.
Publications
Doherty AC, Huddleston DA, Horn PS, Ratner N, Simpson BN, Schorry EK, Aschbacher-Smith L, Prada CE, Gilbert DL. Motor Function and Physiology in Youth With Neurofibromatosis Type 1. Pediatr Neurol. 2023 Jun;143:34-43. doi: 10.1016/j.pediatrneurol.2023.02.014. Epub 2023 Mar 3.
PubMed 36996759Luo Y, Adamek JH, Crocetti D, Mostofsky SH, Ewen JB. Dissociation in Neural Correlates of Hyperactive/Impulsive vs. Inattentive Symptoms in Attention-Deficit/Hyperactivity Disorder. Front Neurosci. 2022 Jun 22;16:893239. doi: 10.3389/fnins.2022.893239. eCollection 2022.
PubMed 35812240Luo Y, Chen C, Adamek JH, Crocetti D, Mostofsky SH, Ewen JB. Altered cortical activation associated with mirror overflow driven by non-dominant hand movement in attention-deficit/hyperactivity disorder. Prog Neuropsychopharmacol Biol Psychiatry. 2022 Jan 10;112:110433. doi: 10.1016/j.pnpbp.2021.110433. Epub 2021 Aug 27.
PubMed 34454990Chen C, Rosch KS, Seymour KE, Crocetti D, Mahone EM, Mostofsky SH. Sex Effects on Mirror Overflow during Finger Tapping in Children with ADHD. J Int Neuropsychol Soc. 2022 Apr;28(4):371-381. doi: 10.1017/S1355617721000576. Epub 2021 May 17.
PubMed 33998435Nikolaidis A, He X, Pekar J, Rosch K, Mostofsky SH. Frontal corticostriatal functional connectivity reveals task positive and negative network dysregulation in relation to ADHD, sex, and inhibitory control. Dev Cogn Neurosci. 2022 Apr;54:101101. doi: 10.1016/j.dcn.2022.101101. Epub 2022 Mar 23.
PubMed 35338900Thapaliya G, Carnell S, Mostofsky SH, Rosch KS. Neurobehavioral phenotypes of delay discounting and cognitive control in child attention-deficit/hyperactivity disorder and obesity: Shared or distinct? Pediatr Obes. 2023 Apr;18(4):e13001. doi: 10.1111/ijpo.13001. Epub 2023 Jan 18.
PubMed 36655309
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anomalous Motor System Physiology in Attention Deficit Hyperactivity Disorder: Biomarker Validation and Modeling Domains of Function
- ClinicalTrials.gov ID
- NCT04421248
- Acronym / sponsor ID
- AMPAIII / CHMC IRB 2020-0297
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Donald Gilbert, MD, MS, FAAN, FAAPUniversity, hospital or other
- Collaborators
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 9 Jun 2020 (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.
Attention-Deficit/Hyperactivity Disorder (ADHD) is the most commonly diagnosed neurobehavioral disorder in childhood. Children with ADHD struggle in school due to problems with attention and high levels of impulsivity and hyperactivity. They are at substantially increased risk for long-term difficulties into adulthood, including academic underachievement, substance abuse, and criminal behavior. The diagnosis of ADHD, which is based on subjective ratings by parents and teachers, likely results from multiple different, overlapping differences in circuits of the brain responsible for attention and impulse control. However, we do not have any scientific or clinical tests that allow us to understand these circuits. In an effort to improve ADHD outcomes, we have used a technology called Transcranial Magnetic Stimulation (TMS) to identify highly reliable measurements of brain function. We have identified two very promising measures that are abnormal in children with ADHD and, importantly, also predict the severity of ADHD behaviors. The goal of this project is to determine if these two TMS measurements could be used to help better guide ADHD treatment. To do this, we will perform three investigations in 8 to 12 year old children to determine: 1) test-retest reliability; 2) pharmacologic responsiveness; and 3) correlations with two domains of function relevant to ADHD: "Cognitive Control" and "Emotional Valence." Through these investigations, we aim to determine whether these two TMS brain measures are reliable and meaningful enough to be used to help improve precision of individually-targeted and effective ADHD treatments.
Detailed description
4.2. NARRATIVE STUDY DESCRIPTION
Summary This is a randomized, blinded, placebo-controlled, single-dose crossover study. The objective is to estimate, in a rigorous, unbiased manner, the effect of 10 mg methylphenidate (MPH) on two putative biomarkers of ADHD, measured using Transcranial Magnetic Stimulation (TMS). Two other aims of this larger study, quantifying test-retest reliability and linking TMS biomarkers to RDoC domains of cognitive control and emotional valence, are not directly part of the clinical trial and are fully described in the research strategy.
Doctors use observations and subjective rating scales both to diagnose Attention Deficit Hyperactivity Disorder (ADHD) and to make decisions about medical or behavioral treatments. This study addresses the possibility that in children with ADHD, brain-based measurements, or biomarkers, could be useful for diagnosis and treatment decisions. These biomarkers are Short Interval Cortical Inhibition (SICI) and Task-Related Up-Modulation (TRUM). These biomarkers may allow clinicians to identify that a child has a "type" of ADHD which might respond more effectively to treatments that are precisely and individually targeted. Thus it is important to estimate the effects of commonly prescribed treatments on SICI and TRUM. This protocol aims to determine the effects of a single 10 mg dose of MPH, a stimulant medication widely prescribed to treat ADHD, on SICI and TRUM.
Assignment of participants For each child with ADHD, participation in the study will consist of three visits. Treatment occurs as a single dose on visits 2 and 3. All participants will receive both placebo and 10 mg MPH. Order will be counterbalanced.
Population Sample At the two study sites, Cincinnati Children's Hospital Medical Center (CCHMC) and the Kennedy Krieger Institute (KKI), we will recruit 144 pre-pubescent children, ages 8 years 0 months to 12 years 11 months, with ADHD. We estimate a total of 120 participants will participate in the full study. All recruitment methods will conform to CCHMC Institutional Review Board (IRB) and HIPAA requirements. The study will be approved by the CCHMC Institutional IRB. Children with ADHD will be primarily recruited through community resources, including local chapters of the Children with ADHD (CHADD), local public and private schools, as well as multiple clinics at CCHMC and KKI.
Study Flow During the first study visit, participants will provide informed consent. They will then complete diagnostic and psychoeducational testing. The parent/guardian will complete standardized questionnaires and a comprehensive psychiatric diagnostic interview with a trained and research reliable psychology associate under the supervision of a neuropsychologist at each site.
At visit 1: if determined to be eligible to continue, visits 2 and 3 will be scheduled at 2-week intervals.
At visit 2: participant will undergo pre-dose TMS for measures of SICI and TRUM, receive either MPH or placebo, then undergo post-dose TMS.
At visit 3: participant will undergo pre-dose TMS measures of SICI and TRUM (test/re-test assessment), receive the opposite treatment of either MPH or placebo, then undergo post-dose TMS.
Intervention - MPH versus Placebo Procedures
The MPH and the placebo will be prepared by the study pharmacy at each site so that they appear identical. Neither the child, the parent, nor the investigators will know which treatment is given. The study pharmacy will randomize children into two groups, without disclosing this information to the researchers or participants. Group 1 will receive MPH on the first treatment visit (visit 2 of the study) and placebo the second. Group 2 will receive placebo on the first treatment visit and MPH the second.
Note: for comparison and validation of the study measures, 70 children who are typically developing and do not have ADHD will also be enrolled. These control participants will not receive methylphenidate or placebo, however.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, blinded, placebo-controlled, single-dose crossover study. The objective is to estimate, in a rigorous, unbiased manner, the effect of 10 mg methylphenidate (MPH) on two putative biomarkers of ADHD, measured using Transcranial Magnetic Stimulation (TMS). Outcomes will be evaluated via repeated measures, mixed model analysis with MEP amplitude as the dependent variable and Treatment and Treatment-Sequence as class variables. Participants will include 144 children with ADHD. Study measures will also be compared in 70 matched, typically developing children who do not have ADHD and who will not receive methylphenidate or placebo.
| Arm | Type | Receives |
|---|---|---|
| Attention Deficit Hyperactivity Disorder (ADHD) | Experimental | Drug: Methylphenidate, Drug: Placebo8 to 12 year old children diagnosed with ADHD. Randomized, blinded, single dose, placebo controlled, crossover trial. |
| Typically developing controls (TDC) | No intervention | –Typically developing controls - 8 to 12 year old children |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Either gender, any race, ethnicity or socioeconomic status
- Currently between 8 years 0 months and 12 years, 11 months, 30 days
- Willing to answer questions about ADHD and related diagnoses
- For children with ADHD prescribed stimulant medications, willing to suspend taking medications as specified in the study procedures
- For children with ADHD, willing to participate in the single dose, randomized crossover study to probe acute effects of methylphenidate on biomarkers
Key exclusion criteria (6 listed)
- Known diagnosis of mental retardation, cerebral palsy, Autism Spectrum Disorder, traumatic brain injury, brain tumor, epilepsy, or other serious neurological disorder.
- Major Depression, Bipolar Disorder, Conduct Disorder, Adjustment Disorder, other Anxiety Disorders, or other developmental psychiatric diagnoses.
- For females, onset of menses, pregnancy.
- Current use of antidepressants, non-stimulant ADHD medications, dopamine blocking agents, mood stabilizers.
- Implanted brain stimulator, vagal nerve stimulator, ventriculo-peritoneal shunt, cardiac pacemaker, or implanted medication port.
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: RitalinIn ADHD participants only: blinded, randomized, placebo-controlled single dose, crossover on separate days separated by at least one week. | Drug | Attention Deficit Hyperactivity Disorder (ADHD) |
| PlaceboIn ADHD participants only: blinded, randomized, placebo-controlled, single dose, crossover on separate days separated by at least one week. | Drug | Attention Deficit Hyperactivity Disorder (ADHD) |
Primary outcome
Transcranial Magnetic Stimulation (TMS)-evoked Short Interval Cortical Inhibition (SICI) Test-Retest Reliability
Time frame: less than one month
A ratio of amplitudes of motor evoked potentials from paired (inhibitory) and single TMS pulses, obtained from dominant motor cortex with hand at rest
Transcranial Magnetic Stimulation (TMS)-evoked Task Related Up Modulation (TRUM) Test-Retest Reliability
Time frame: less than one month
A ratio of amplitudes of motor evoked potentials during engagement in a response inhibition task versus rest, obtained from dominant motor 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 25 Sep 2026.
- Background: PubMed 36996759Doherty AC, Huddleston DA, Horn PS, Ratner N, Simpson BN, Schorry EK, Aschbacher-Smith L, Prada CE, Gilbert DL. Motor Function and Physiology in Youth With Neurofibromatosis Type 1. Pediatr Neurol. 2023 Jun;143:34-43. doi: 10.1016/j.pediatrneurol.2023.02.014. Epub 2023 Mar 3.
- Background: PubMed 35812240Luo Y, Adamek JH, Crocetti D, Mostofsky SH, Ewen JB. Dissociation in Neural Correlates of Hyperactive/Impulsive vs. Inattentive Symptoms in Attention-Deficit/Hyperactivity Disorder. Front Neurosci. 2022 Jun 22;16:893239. doi: 10.3389/fnins.2022.893239. eCollection 2022.
- Background: PubMed 34454990Luo Y, Chen C, Adamek JH, Crocetti D, Mostofsky SH, Ewen JB. Altered cortical activation associated with mirror overflow driven by non-dominant hand movement in attention-deficit/hyperactivity disorder. Prog Neuropsychopharmacol Biol Psychiatry. 2022 Jan 10;112:110433. doi: 10.1016/j.pnpbp.2021.110433. Epub 2021 Aug 27.
- Background: PubMed 33998435Chen C, Rosch KS, Seymour KE, Crocetti D, Mahone EM, Mostofsky SH. Sex Effects on Mirror Overflow during Finger Tapping in Children with ADHD. J Int Neuropsychol Soc. 2022 Apr;28(4):371-381. doi: 10.1017/S1355617721000576. Epub 2021 May 17.
- Background: PubMed 35338900Nikolaidis A, He X, Pekar J, Rosch K, Mostofsky SH. Frontal corticostriatal functional connectivity reveals task positive and negative network dysregulation in relation to ADHD, sex, and inhibitory control. Dev Cogn Neurosci. 2022 Apr;54:101101. doi: 10.1016/j.dcn.2022.101101. Epub 2022 Mar 23.
- Background: PubMed 36655309Thapaliya G, Carnell S, Mostofsky SH, Rosch KS. Neurobehavioral phenotypes of delay discounting and cognitive control in child attention-deficit/hyperactivity disorder and obesity: Shared or distinct? Pediatr Obes. 2023 Apr;18(4):e13001. doi: 10.1111/ijpo.13001. Epub 2023 Jan 18.
- Individual participant dataSharing planned: Yes. Sharing of individual participant data (IPD) will occur through the National Institute of Mental Health (NIMH) Data Archive, consistent with the NIMH Data Sharing Policy. This includes all raw and analyzed data, including clinical, phenotypic, and neurophysiological biomarker data, which will be de-identified and deposited in the NIMH Data Archive (NDA). Data from research subjects will include Required Data Elements: 1) NDA Global Unique Identifier assigned to participants (GUID); 2) the study's internal subject identifier (Src_subject_id); 3) interview age in months (interview_age); 4) data collection date (interview_date); and 5) birth sex.
Related trials for Attention Deficit Hyperactivity Disorder Combined
Not yet recruitingPhase 2
A Clinical Trial Evaluating Fecal Microbiota Transplantation (FMT) in Adolescents With ADHD
ADHD, ADHD - Attention Deficit Disorder With Hyperactivity
RecruitingPhase 2
Efficacy of Reboxetine and Methylphenidate Treatment on Attentional, Sensory and Emotional Dysregulation in Adults With PTSD
Posttraumatic Stress Disorder
RecruitingPhase 2
Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
Neurodevelopmental Disorders, Autism
Not yet recruitingObservational study
Cardiovascular Abnormalities in Children With Attention-deficit/Hyperactivity Disorder
ADHD - Combined Type
Recruiting
Effects and Mechanisms of Transcranial Direct Current Stimulation Combined With Dialectical Behavior Therapy Skills Training in Adults With Attention-Deficit/Hyperactivity Disorder
Adult Attention Deficit Hyperactivity Disorder
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.
Donald L Gilbert, MD principal investigator
Children's Hospital Medical Center, Cincinnati
Stewart H Mostofsky, MD principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
2 sites 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 Attention Deficit Hyperactivity Disorder Combined, run by Donald Gilbert, MD, MS, FAAN, FAAP at 2 sites 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 9 inclusion and 6 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 Donald L Gilbert, MD (800-344-2462, donald.gilbert@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcranial Magnetic Stimulation (TMS)-evoked Short Interval Cortical Inhibition (SICI) Test-Retest Reliability (time frame: less than one month). 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?
On the ClinicalTrials.gov record for NCT04421248, which also lists 6 linked publications.
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 25 Sep 2026.