Biomarkers of ADHD Treatment Response

Completed · Phase 1

Conditions studied: ADHD

In brief

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.

Key facts

Study ID

NCT05650775

Run by

Boston Children's Hospital

People needed

16

Starts

2023-02-17

Expected to finish

2024-03-30

Last updated by the study team

2024-12-18

Who can join

Age: 7 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pediatric patients ages 7-11 seen at the Children's Hospital Primary Care Center
• Have a diagnosis of ADHD or referred for an ADHD evaluation
• Have not previously trialed stimulant medication

You may not qualify if…

• Diagnoses of intellectual disability, autism, prior suicide attempt, current psychotropic medication use, known genetic syndrome, color-blindness
• History of nonfebrile seizures
• Gestational age < 32 weeks
• Prenatal alcohol or substance exposure
• Medical conditions that contraindicate psychostimulant use (e.g., cardiac concerns).

Where it is running

• 2 Brookline Place — Brookline, Massachusetts, United States

Full record on ClinicalTrials.gov

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