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NCT05650775 · ClinicalTrials.gov registry record · Phase 1

Biomarkers of ADHD Treatment Response

A Phase 1 study, sponsored by Boston Children's Hospital.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT05650775: Completed Phase 1 study, sponsored by Boston Children's Hospital.

NCT05650775 is a Phase 1 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05650775, a Phase 1 study, has completed, sponsored by Boston Children's Hospital.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

The goal of this translational biomarker study is to use electroencephalography (EEG) to identify brain signatures that will predict a child's response to two of the most commonly prescribed ADHD medications, methylphenidate and mixed amphetamine salts. The main questions the investigators aim to answer are: 1. Do children with ADHD who show symptom reduction with methylphenidate have different EEG profiles than children who do not respond well to methylphenidate? 2. Do children who respond better to mixed amphetamine salts than to methylphenidate have unique EEG profiles? The investigators will measure brain activity before the participating children have tried any stimulant medications, and then again after a 3-week trial of Concerta (methylphenidate). Participants who do not show significant symptom improvement on Concerta will then complete a 3-week trial of Adderall (mixed amphetamine salts), and the study will measure brain activity while those children are on the best dose of Adderall. The investigators will collect information from the child, caregivers, and teachers each week to measure ADHD symptom improvement and side effects. This study will therefore follow the typical treatment approach used in the Boston Children's Hospital Developmental Medicine Clinic, but the investigators will add measures of brain functioning before and after medication.

Primary Outcome

Vanderbilt ADHD Ratings from the parent and teacher will be collected at baseline and weekly during each of the 3-week medication trials to guide further dosing and study disposition. Patients with at least 30% ADHD symptom reduction on both parent and teacher rating scales at the end of the 3-week Concerta trial will return to standard clinical care with their primary care provider. Patients with less than 30% ADHD symptom reduction at the end of the 3-week Concerta/Methylphenidate trial will c

Interventions

  • DRUG Adderall-XR
  • DRUG Concerta

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2023-02-17
Est. Completion 2024-03-30
Phase Phase 1
Boston Children's Hospital

462 total trials

What the finished NCT05650775 record still lists

NCT05650775 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 2 interventions - of which Adderall-XR is the first listed.

NCT05650775 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05650775 about?

NCT05650775 is a clinical study titled "Biomarkers of ADHD Treatment Response". The goal of this translational biomarker study is to use electroencephalography (EEG) to identify brain signatures that will predict a child's response to two of the most commonly prescribed ADHD medications, methylphenidate and mixed amphetamine salts. The main questions the investigators aim to an...

What is the current status of trial NCT05650775?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2023-02-17. Estimated completion is 2024-03-30.

What interventions are being tested in trial NCT05650775?

The interventions under investigation include: Adderall-XR (DRUG), Concerta (DRUG).

Who is sponsoring clinical trial NCT05650775?

This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05650775's enrollment target sits among peer trials

16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT05650775, the US trial registry maintained by the National Library of Medicine. NCT05650775 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.