What is the mechanism of action of this treatment?

The most common treatments for ADHD include stimulant medications like methylphenidate and mixed amphetamine salts, which work by increasing the levels of neurotransmitters dopamine and norepinephrine in the brain. These neurotransmitters play key roles in attention and behavior regulation, helping to improve focus and reduce impulsivity and hyperactivity in ADHD patients. Behavioral therapies, such as cognitive-behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT), aim to teach coping strategies and improve executive functioning through structured skill-building and mindfulness practices. These treatments are crucial for ADHD patients as they address both the neurochemical and behavioral aspects of the disorder, leading to better overall management of symptoms.

What side effects are associated with this type of intervention?

The most common treatments for ADHD include stimulant medications such as methylphenidate and mixed amphetamine salts, and non-stimulant medications like atomoxetine. Stimulant medications can cause side effects such as increased heart rate, elevated blood pressure, insomnia, decreased appetite, and potential cardiovascular symptoms like tachycardia and palpitations. Atomoxetine, a selective norepinephrine reuptake inhibitor, may lead to modest increases in heart rate and blood pressure, and can also cause gastrointestinal issues, fatigue, and mood swings. Both types of medications require monitoring for cardiovascular effects, especially in patients with pre-existing heart conditions.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of ADHD, including stimulants like methylphenidate (e.g., Concerta) and mixed amphetamine salts (e.g., Adderall). These medications are commonly prescribed due to their efficacy in reducing core symptoms of ADHD. Additionally, non-stimulant options such as atomoxetine, a selective norepinephrine reuptake inhibitor, and alpha-2 adrenergic agonists like guanfacine extended-release have also received FDA approval. These treatments offer alternatives for patients who may not respond well to stimulants or experience significant side effects.

What other types of research exist?

Promising novel alternatives to EEG monitoring for ADHD patients include the use of deep learning-based analysis of EEG data, which has shown high accuracy in diagnosing ADHD. Additionally, the development of subscalp EEG devices for ultra-long-term recordings offers a less invasive and more continuous monitoring option. These advancements could provide more precise and individualized treatment plans for ADHD patients.

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Central Nervous System Stimulant

ADHD Medications for Attention Deficit Hyperactivity Disorder (ADHD) (BAT Trial)

Phase 1

Recruiting

Led By Anne Arnett, PhD

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline & 3 months after trial completion

Awards & highlights

Summary

This trial uses brain activity measurements to understand how children with ADHD will respond to two common medications. It focuses on children aged 7-11 who have not taken these medications before. By comparing brain activity at different times, researchers aim to find patterns that indicate which medication works best for each child. Methylphenidate is a widely used stimulant for treating ADHD, with studies exploring its benefits.

Who is the study for?

This trial is for children aged 7-11 with ADHD who haven't tried stimulant medications yet. They must be patients at the Children's Hospital Primary Care Center. Kids can't join if they have certain medical conditions like heart issues, intellectual disability, autism, a history of seizures or suicide attempts, are on other psychotropic meds, were born very premature or had prenatal substance exposure.

What is being tested?

The study tests how well kids with ADHD respond to two common meds: Concerta and Adderall-XR. It uses EEG to find brain activity patterns that might predict which med works better for them. First tested with Concerta for 3 weeks; if no improvement, then tested with Adderall-XR for another 3 weeks while monitoring symptoms and side effects.

What are the potential side effects?

Possible side effects from Concerta (methylphenidate) and Adderall-XR (mixed amphetamine salts) include trouble sleeping, decreased appetite, stomach pain, headaches, jitteriness and mood swings.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 3 months after trial completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 3 months after trial completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 months after trial completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Baseline EEG Cued P3 Amplitude

Baseline EEG Novelty P3 Amplitude

Baseline EEG Resting Alpha Peak Frequency

+14 more

Secondary study objectives

Change in Externalizing Symptoms

Change in Internalizing Symptoms

Change in Tests of Variables of Attention (TOVA) Commission errors on Adderall-XR

+11 more

Trial Design

2Treatment groups

Active Control

Group I: Mixed Amphetamine Salts TrialActive Control1 Intervention

3-week trial of mixed amphetamine salts with weekly dose adjustments.

Group II: Methylphenidate TrialActive Control1 Intervention

3-week methylphenidate trial with weekly dose adjustments.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ADHD include stimulant medications like methylphenidate and mixed amphetamine salts, which work by increasing the levels of neurotransmitters dopamine and norepinephrine in the brain. These neurotransmitters play key roles in attention and behavior regulation, helping to improve focus and reduce impulsivity and hyperactivity in ADHD patients. Behavioral therapies, such as cognitive-behavioral therapy (CBT) and mindfulness-based cognitive therapy (MBCT), aim to teach coping strategies and improve executive functioning through structured skill-building and mindfulness practices. These treatments are crucial for ADHD patients as they address both the neurochemical and behavioral aspects of the disorder, leading to better overall management of symptoms.

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Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

778 Previous Clinical Trials

5,580,982 Total Patients Enrolled

6 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)

1,293 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Anne Arnett, PhDPrincipal InvestigatorBoston Children's Hospital

Eugenia Chan, MDPrincipal InvestigatorBoston Children's Hospital

~12 spots leftby Sep 2025

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