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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 is a Phase 1 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 16 participants.
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.
Interventions
- DRUG Adderall-XR
- DRUG Concerta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2023-02-17 |
| Est. Completion | 2024-03-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05650775
The ClinicalTrials.gov registry entry for NCT05650775 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 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 Adderall-XR is the first listed.
NCT05650775 reports 0 study locations.
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.
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