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NCT07650643 · ClinicalTrials.gov registry record · Phase 4
EEG Biomarkers for ADHD Stimulant Treatment
A Phase 4 study, sponsored by Boston Children's Hospital.
- Not yet
- Registry status
- Phase 4
- Development phase
- 220
- Enrollment target
NCT07650643 is a Phase 4 study that has not yet begun recruiting, run by Boston Children's Hospital. The registered enrollment target is 220 participants.
The verdict
NCT07650643, a Phase 4 study, has not yet begun recruiting, sponsored by Boston Children's Hospital.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 220 participants
- Enrollment target
Study Summary
Pediatric attention deficit hyperactivity disorder (ADHD) affects up to 10% of children in the U.S. and more than 90% are prescribed stimulant medications according to clinical guidelines. The standard of care for pharmacological treatment of ADHD is a "trial-and-error" approach that requires frequent dose adjustments, side effects management, and communication among doctors, parents, and school personnel over weeks, months, and years. In the first year following prescription of stimulant medications, \>50% of doctors are not able to conduct the recommended follow-up with their patients. Many patients stop taking medications or keep taking medications that do not work well, as a result. This investigation will use a non-invasive brain imaging technique called EEG to look for activity in the brain that can predict which children with ADHD will respond well to two commonly prescribed stimulant medication groups, methylphenidate and amphetamines. Based on a previous study, it is expected that EEG signals can differentiate among children whose ADHD symptoms will get better on methylphenidate, and those whose ADHD symptoms will get better on amphetamines. 220 participants ages 7-11 with ADHD will be enrolled. Participants will not have autism or intellectual disabiltiy. They will not currently be taking psychiatric medications. Participants will not have not taken stimulant medications before or have tried stimulant medications \>6 months or experienced an improvement in their ADHD symptoms by taking a stimulant medication before. Study Participation Includes: 1. Participant and caregiver complete a 3-hour visit at the Arnett Laboratory at 2 Brookline Place. During this visit, participants complete a brief IQ test and an EEG while their caregiver completes questionnaires and a clinical interview. The caregiver will give permission to request survey responses from the participant's teacher. 2. The next day, the participant and caregiver will come back to the laborator
Interventions
- DRUG Mixed amphetamine salts extended release
- DRUG methylphenidate HCl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2026-09-15 |
| Est. Completion | 2031-08-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07650643
The ClinicalTrials.gov registry entry for NCT07650643 describes a study currently listed as not yet recruiting, categorized as Phase 4. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mixed amphetamine salts extended release is the first listed.
NCT07650643 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07650643 about?
NCT07650643 is a clinical study titled "EEG Biomarkers for ADHD Stimulant Treatment". Pediatric attention deficit hyperactivity disorder (ADHD) affects up to 10% of children in the U.S. and more than 90% are prescribed stimulant medications according to clinical guidelines. The standard of care for pharmacological treatment of ADHD is a "trial-and-error" approach that requires freque...
What is the current status of trial NCT07650643?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 220 participants. The study started on 2026-09-15. Estimated completion is 2031-08-31.
What interventions are being tested in trial NCT07650643?
The interventions under investigation include: Mixed amphetamine salts extended release (DRUG), methylphenidate HCl (DRUG).
Who is sponsoring clinical trial NCT07650643?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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