Attention Deficit Hyperactivity Disorder Combined study: Methylphenidate
Official title Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder
ClinicalTrials.gov ID: NCT04421248
What this study is testing
What is Methylphenidate?
An investigational drug being studied for Attention Deficit Hyperactivity Disorder (ADHD) in children.
Also referred to as Ritalin.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether two TMS brain measurements are reliable and useful for guiding ADHD treatment. It looks at how well the measurements repeat, respond to medication, and relate to attention and emotion.
- Who it's for
- You may be able to join if you are a child aged 8 to 12 with ADHD combined type and your parents agree to let you participate.
- What's involved
- You will have a TMS test on your head, which is a safe, painless magnetic pulse. The test will be done several times to see if the results stay the same. You may also take a medication and have the test again to see how it changes. You will also do some simple tasks to measure attention and emotions.
- Time commitment
- The study lasts about a month, with a few visits for TMS testing and medication checks.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 12. Healthy volunteers may be eligible.
You may be able to join if
- 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, assigned by chance crossover study to probe acute effects of methylphenidate on...
You likely can't join if
- Known diagnosis of mental retardation, cerebral palsy, Autism Spectrum Disorder, traumatic brain injury, brain tumor, epilepsy, or other serious...
- 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).
See the full eligibility criteria
- 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, assigned by chance crossover study to probe acute effects of methylphenidate on biomarkers
- Right hand dominant (predominately right-handed)
- 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.
- 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.
- 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).
The study team makes the final eligibility decision.
Where it is enrolling
- Baltimore, Maryland, United States
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 12 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Baltimore, Maryland, United States; Cincinnati, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.