Phase 4 ADHD Trial, Recruiting NCT04219280 Sponsor: Children's Hospital Medical Center, Cincinnati Condition: ADHD
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Phase 4 ADHD Trial, Recruiting

NCT04219280
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:

  • You must be willing to follow all study requirements and be available for the full length of the study.
  • Children and teenagers between the ages of 6 and 17 years old (at the time of signing up) may be eligible.
  • The child must be able to swallow liquid medication by mouth.
  • English must be the child's main language.
  • The child must meet the criteria for ADHD (hyperactive type, inattentive type, or combined type) based on a structured interview called the KSADS.
  • The child must also meet the criteria for ADHD based on a questionnaire called the Vanderbilt, either now or in the past, as reported by a teacher or other professional.

Who may not be able to join:

  • Children who are currently taking ADHD medication (stimulant or non-stimulant) and are not willing to stop taking it for at least 3 days before the study starts.
  • Children who have been diagnosed with psychosis or bipolar disorder, based on an interview with a parent.
  • Children who have a history of a serious head injury with loss of consciousness, epilepsy, or any other brain condition that could affect how the brain works.
  • Children with certain heart conditions, including an abnormal heart rhythm reading on an ECG, a heart rate or blood pressure that is unusually high for their age, certain structural heart problems detected by heart scan (ECHO), a history of sudden cardiac arrest or unexplained fainting, or the use of a pacemaker (confirm with trial site for full list of specific heart conditions).
  • Children with certain other heart findings on ECG may still be able to join but must first be assessed by a heart doctor (cardiologist) before starting the study (confirm with trial site).
  • Children who are currently taking a type of medication called a monoamine oxidase inhibitor (MAOI), or who have taken one within the last 14 days.
  • Children who are currently in the process of having their dose adjusted for any non-ADHD psychiatric medication — however, children on a stable dose of such medication (no changes for at least 4 weeks) may still be eligible.
  • Children who are known to be allergic or sensitive to methylphenidate (the active drug being studied) or to bananas, as banana flavoring is used in the study medication.
  • Children with severe obstructive sleep apnea (a serious breathing condition during sleep), rated at a severity level of 4 on the McGill scale.
  • Girls who are pregnant — a pregnancy test will be done at the medical screening for any female participant who has started their menstrual cycle, and those who are pregnant will not be able to join.

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: Anna Esbensen, PhD, Children's Hospital Medical Center, Cincinnati

Phone: 513-803-3641

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
Registry
ClinicalTrials.gov
Start date
2 October 2020
Est. completion
30 September 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Mean magnitude of change in ADHD Symptoms as measured by parent and teacher report on the Vanderbilt ADHD Parent and Teacher Rating Scales, compared to placebo, during the optimal MPH dosage period. [ Time Frame: Phase 2, Phase 3 ]; Mean magnitude of change in Emotion Regulation as measured by parent and teacher report on the BRIEF2, compared to placebo, during the optimal MPH dosage period. [ Time Frame: Phase 2, Phase 3 ]

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