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RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Methylphenidate for Attention Deficit Hyperactivity Disorder Combined

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.

Official registry: https://clinicaltrials.gov/study/NCT04421248 · Donald Gilbert, MD, MS, FAAN, FAAP · enrollment listed as 214

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Methylphenidate, or Placebo. The registry lists allocation as randomized. Attention-Deficit/Hyperactivity Disorder (ADHD) is the most commonly diagnosed neurobehavioral disorder in childhood.

They plan to enroll about 214 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Anomalous Motor System Physiology in Attention Deficit Hyperactivity Disorder: Biomarker Validation and Modeling Domains of Function

Interventions: Methylphenidate, Placebo

Primary outcome (registry wording): Transcranial Magnetic Stimulation (TMS)-evoked Short Interval Cortical Inhibition (SICI) Test-Retest Reliability

Who it is for (from inclusion criteria)

  • Ages 8 Years to 12 Years
  • 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
  • Right hand dominant (predominately right-handed)
  • 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

Public study contact (from the registry)

Donald L Gilbert, MD

800-344-2462

donald.gilbert@cchmc.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

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FAQ about this NCT record

Is NCT04421248 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT04421248?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT04421248?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary