Phase 4 ADHD Trial, Recruiting NCT04421248 Sponsor: Donald Gilbert, MD, MS, FAAN, FAAP Condition: ADHD
Back to Adhd

Phase 4 ADHD Trial, Recruiting

NCT04421248
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Children of any gender, race, ethnicity, or socioeconomic background
  • Children currently aged between 8 years 0 months and 12 years, 11 months, and 30 days old
  • Children who are willing to answer questions about ADHD and related conditions
  • Children with ADHD who are willing to temporarily stop taking prescribed stimulant medications as directed by the study procedures
  • Children with ADHD who are willing to take part in a single-dose study that looks at how a medication called methylphenidate affects certain biological markers in the body
  • Children who are predominantly right-handed
  • Children who are able to take part in and sign an informed consent form
  • Children with ADHD whose diagnosis meets recognised medical guidelines (DSM-5), which may include a condition called Oppositional Defiant Disorder
  • Healthy children (without ADHD) who have no ADHD or other developmental or psychiatric conditions, based on recognised medical guidelines (DSM-5)

Who may not be able to join:

  • Children who have been diagnosed with intellectual disability, cerebral palsy, Autism Spectrum Disorder, traumatic brain injury, brain tumour, epilepsy, or another serious neurological condition
  • Children who have been diagnosed with Major Depression, Bipolar Disorder, Conduct Disorder, Adjustment Disorder, an anxiety disorder, or another developmental psychiatric condition
  • Girls who have begun their menstrual period, or who are pregnant
  • Children currently taking antidepressants, non-stimulant ADHD medications, dopamine-blocking medications, or mood-stabilising medications
  • Children who have an implanted medical device, such as a brain stimulator, vagal nerve stimulator, a shunt in the brain, a cardiac pacemaker, or an implanted medication port
  • Children who have been diagnosed with a speech or language disorder, or a reading disability

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Donald L Gilbert, MD, Children's Hospital Medical Center, Cincinnati

Phone: 800-344-2462

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Donald Gilbert, MD, MS, FAAN, FAAP
Registry
ClinicalTrials.gov
Start date
1 September 2020
Est. completion
9 February 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Transcranial Magnetic Stimulation (TMS)-evoked Short Interval Cortical Inhibition (SICI) Test-Retest Reliability; Transcranial Magnetic Stimulation (TMS)-evoked Task Related Up Modulation (TRUM) Test-Retest Reliability

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov