Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2023-02-17
2024-03-30
Brief Summary
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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.
Detailed Description
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With the support of the Translational Neuroscience Center Clinical Research Operations services and in collaboration with the Boston Children's Hospital Primary Care Center (CHPCC), the investigators will execute a sequential crossover design study examining pre-treatment EEG and ERP biomarkers of response to methylphenidate (MPH; Concerta) among all children and to mixed amphetamine salts (MAS; Adderall-XR) among children with suboptimal response to MPH. Additional pre- and post-treatment assessments will be integrated with standard clinical care provided by Dr. Chan (co-PI) in the Division of Developmental Medicine. The study will recruit 30 stimulant-treatment-naïve children with ADHD, ages 7-11, from the CHPCC. Additionally, analyses will capitalize on Dr. Arnett's (co-PI) existing EEG/ERP data on 40 typically developing (TD) children in the same age range to maximize power for statistical comparisons.
The investigators hypothesize that, consistent with Dr. Arnett's prior work, the EEG and ERP profiles will differentiate children with positive response to MPH versus preferential response to MAS. Specifically, the investigators hypothesize that MPH responders will have reduced P3 ERP amplitude and normal aperiodic spectral slope, while MAS preferential responders will have normal P3 amplitude and flatter aperiodic spectral slope. The investigators expect that slow individual alpha peak will be associated with reduced response to both MPH and MAS, as suggested by prior literature. Additionally, the investigators hypothesize that at optimal dosing, treatment-related change in EEG/ERP biomarkers will be associated with ADHD symptom improvement; this will indicate that individual differences in psychostimulant response reflect individual differences in the neurobiological etiology of ADHD symptoms.
The results of this pilot study will support application for federal funding for a large-scale clinical trial. The long-term outcomes of this line of research stand to benefit children and families with ADHD, as well as children with other primary diagnoses commonly associated with ADHD (e.g., autism spectrum disorder; genetic syndromes). Moreover, differences in neurophysiological correlates of differential stimulant response have potential to increase our knowledge of neural mechanisms underlying psychostimulant medication effects.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Methylphenidate Trial
3-week methylphenidate trial with weekly dose adjustments.
Concerta
3-week trial of oral methylphenidate extended release
Mixed Amphetamine Salts Trial
3-week trial of mixed amphetamine salts with weekly dose adjustments.
Adderall-XR
3-week trial of oral mixed amphetamine salts, extended release, administered only to children who do not show at least 30% improvement during the Concerta/Methylphenidate trial.
Interventions
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Concerta
3-week trial of oral methylphenidate extended release
Adderall-XR
3-week trial of oral mixed amphetamine salts, extended release, administered only to children who do not show at least 30% improvement during the Concerta/Methylphenidate trial.
Eligibility Criteria
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Inclusion Criteria
* Have a diagnosis of ADHD or referred for an ADHD evaluation
* Have not previously trialed stimulant medication
Exclusion Criteria
* History of nonfebrile seizures
* Gestational age \< 32 weeks
* Prenatal alcohol or substance exposure
* Medical conditions that contraindicate psychostimulant use (e.g., cardiac concerns).
7 Years
11 Years
ALL
No
Sponsors
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Boston Children's Hospital
OTHER
Responsible Party
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Anne Arnett
Assistant Professor
Principal Investigators
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Anne B Arnett, PhD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Eugenia Chan, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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2 Brookline Place
Brookline, Massachusetts, United States
Countries
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Other Identifiers
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ArnettChanTNC2022
Identifier Type: -
Identifier Source: org_study_id