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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: Clinical Trial Phase 4 study, sponsored by Boston Children's Hospital.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Clinician rating of participant ADHD symptom improvement on medication A. The Clinical Global Impressions - Improvement Scale (CGI-I) is rated by a trained study clinician on a scale of 1-7, with scores of 1 ("very much improved") and 2 ("much improved") corresponding to clinically significant symptom improvement. Scores of 3-7 will indicate no improvement or worsening of symptoms.
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 |
What is known before NCT07650643 opens enrollment
NCT07650643 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Mixed amphetamine salts extended release is the first listed.
NCT07650643 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07650643's enrollment target sits among peer trials
220 385th of 2000 higher than 1,612 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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