ADHD Medications for Attention Deficit Hyperactivity Disorder (ADHD)

(BAT Trial)

Overseen By Katherine Pawlowski, MA

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Boston Children's Hospital

Must not be taking: Psychotropic medications

Disqualifiers: Intellectual disability, Autism, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how children's brain activity, measured by EEG (a test that tracks brain waves), can predict their response to two common ADHD medications: Concerta and Adderall. The researchers seek to determine if differences in brain activity explain why some children respond better to one medication than the other. Children aged 7-11 with ADHD who haven't tried stimulant medication before might be suitable for this trial. The study measures symptom improvement and any side effects while tracking brain activity before and after trying these medications. As a Phase 1 trial, this research focuses on understanding how these medications work in children, offering participants a chance to contribute to groundbreaking insights.

Will I have to stop taking my current medications?

The trial requires that participants have not previously used stimulant medications and are not currently using any psychotropic medications (drugs that affect mood, perception, or behavior). If you are taking such medications, you would need to stop before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Concerta (methylphenidate) and Adderall (mixed amphetamine salts) are generally safe and effective for treating ADHD in children and teens. Studies have found that Concerta can cause mild side effects such as trouble sleeping and reduced appetite. However, long-term use beyond two years has proven safe without major issues.

For Adderall, research indicates it is well-tolerated, with common side effects like trouble sleeping and dry mouth. Importantly, studies have not identified a higher risk of serious heart problems in children using these ADHD medications. These findings suggest that both treatments are generally safe for kids, with minor side effects that should be monitored. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard ADHD medications, which often use either mixed amphetamine salts or methylphenidate as active ingredients, Concerta provides a unique delivery system that offers extended-release methylphenidate. This allows for more consistent symptom management throughout the day with just a single dose, reducing the need for multiple doses and potentially improving adherence. Researchers are excited about Concerta because it targets the same pathways as typical ADHD medications but does so in a way that might offer fewer peaks and troughs in symptom control, contributing to a smoother experience for patients.

What evidence suggests that this trial's treatments could be effective for ADHD?

Research has shown that both methylphenidate and mixed amphetamine salts effectively treat ADHD symptoms. In this trial, participants will join one of two treatment arms: the Methylphenidate Trial or the Mixed Amphetamine Salts Trial. Studies indicate that methylphenidate can improve ADHD symptoms and general behavior in children and teens, as rated by teachers. One study found that ADHD symptoms significantly improved after 12 weeks of using methylphenidate. Mixed amphetamine salts have also proven very effective, with a 42% reduction in ADHD symptoms according to the ADHD Rating Scale. Both medications have enhanced quality of life compared to a placebo. These findings suggest that both treatments can significantly help manage ADHD symptoms in children. ^{5 6 7 8 9}

Who Is on the Research Team?

Eugenia Chan, MD

Principal Investigator

Boston Children's Hospital

Anne B Arnett, PhD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Have a diagnosis of ADHD or referred for an ADHD evaluation

I am a child aged 7-11 and am seen at the Children's Hospital Primary Care.

I have never taken stimulant medication before.

Exclusion Criteria

I have an intellectual disability, autism, or a known genetic syndrome.

I don't have heart issues that prevent me from using stimulant medications.

Prenatal alcohol or substance exposure

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

EEG and ERP measurements are taken before any medication is administered

1 week

1 visit (in-person)

Methylphenidate Trial

Participants undergo a 3-week trial of Concerta (methylphenidate) with weekly dose adjustments and EEG measurements

3 weeks

3 visits (in-person)

Adderall-XR Trial

Participants who do not respond to Concerta undergo a 3-week trial of Adderall-XR with weekly dose adjustments and EEG measurements

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for long-term changes in ADHD symptoms and side effects

6 months

Periodic assessments

What Are the Treatments Tested in This Trial?

Interventions

• Adderall-XR
• Concerta

Trial Overview 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.

How Is the Trial Designed?

Group I: Mixed Amphetamine Salts Trial Active Control 1 Intervention

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

Group II: Methylphenidate Trial Active Control 1 Intervention

3-week methylphenidate trial with weekly dose adjustments.

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

In a four-week trial involving 119 Korean children with ADHD, Concerta (OROS methylphenidate) was found to be well tolerated and effective in improving attention, behavior, and cognitive function as reported by parents, teachers, and investigators.

The study demonstrated significant improvements in cognitive performance through various tests, supporting the use of Concerta as a beneficial once-daily treatment option for children with ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of OROS methylphenidate in Korean children with attention-deficit/hyperactivity disorder. Lee, SI., Hong, SD., Kim, SY., et al.[2013]

In a study involving 105 children and adolescents with ADHD, switching from immediate-release methylphenidate (MPH) to OROS MPH (a long-acting formulation) maintained and potentially improved ADHD symptom control over 21 days.

Approximately 75% of parents and investigators rated the OROS MPH therapy as good or excellent, indicating it was well tolerated and effective, particularly in managing symptoms during the after-school period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom control in children and adolescents with attention-deficit/hyperactivity disorder on switching from immediate-release MPH to OROS MPH Results of a 3-week open-label study. Remschmidt, H., Hoare, P., Ettrich, C., et al.[2022]

A review of 43 studies involving around 7000 children found that common adverse drug reactions (ADRs) from ADHD medications included decreased appetite, gastrointestinal pain, and headaches, primarily reported by children or their parents.

Most studies reported low rates of serious ADRs, but many children dropped out due to serious reactions, suggesting that the actual incidence of serious ADRs may be higher, highlighting the need for long-term safety studies on ADHD medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD) medications in the pediatric population: a qualitative review of empirical studies. Aagaard, L., Hansen, EH.[2021]

A study analyzing adverse events from nonstimulant ADHD medications (atomoxetine, clonidine, and guanfacine) found that common side effects include ineffectiveness (up to 14.15%), fatigue (8.93%), and somnolence (up to 10.16%).

Suicidal ideation was reported among users of all three medications, highlighting the importance of monitoring and educating patients about potential serious side effects, even though they occur less frequently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective analysis of adverse events associated with non-stimulant ADHD medications reported to the united states food and drug administration. Pang, L., Sareen, R.[2021]

The safety profile of ADHD medications is not fully understood, with concerns about both older and newer medications potentially causing serious adverse effects, including sudden cardiac death and suicidality.

A review by the European Network for Hyperkinetic Disorders highlighted that while some adverse effects may be minimal or similar to risks in untreated individuals, further research is needed to clarify the safety risks associated with ADHD medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European guidelines on managing adverse effects of medication for ADHD. Graham, J., Banaschewski, T., Buitelaar, J., et al.[2022]

In a 7-week study involving 226 adults with ADHD, OROS methylphenidate significantly improved ADHD symptoms compared to placebo, as shown by lower scores on the Adult ADHD Investigator Symptom Report Scale.

The treatment was well tolerated, with no serious adverse events reported, and a higher percentage of participants on OROS methylphenidate were classified as responders compared to those on placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, double-blind, parallel group, dose-escalation study. Adler, LA., Zimmerman, B., Starr, HL., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11483144/

Efficacy of a mixed amphetamine salts compound in adults ... Drug-specific improvement in ADHD symptoms was highly significant overall (42% decrease on the ADHD Rating Scale, P<.001), and sufficiently robust to be ...

2. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/205820

Efficacy of a Mixed Amphetamine Salts Compound in ... Drug-specific improvement in ADHD symptoms was highly significant overall (42% decrease on the ADHD Rating Scale, P<.001), and sufficiently robust to be ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0890856724003046

Systematic Review and Meta-Analysis: Effects of ... The analysis showed that medications such as amphetamines, methylphenidate, and atomoxetine improved QoL compared to placebo, with moderate effect sizes.

4. tandfonline.com tandfonline.com/doi/full/10.1080/14737175.2024.2321921

A review of amphetamine extended release once-daily ... Multiple studies showed significant improvement in symptoms of attention deficit hyperactivity disorder with mixed amphetamine salts. Original ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00712699

Effectiveness of an Extended Release Stimulant ... This study will evaluate the safety and effectiveness of extended release mixed amphetamine salts in treating preschool children with attention deficit ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16678648/

Efficacy and safety of mixed amphetamine salts ... - PubMed Results of this study suggest that once-daily dosing with MAS XR up to 40 mg was effective and well tolerated for the management of ADHD in these adolescents.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149291806000518

Efficacy and safety of mixed amphetamine salts extended ... Results of this study suggest that once-daily dosing with MAS XR up to 40 mg was effective and well tolerated for the management of ADHD in these adolescents.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833773

Safety of Stimulants Across Patient Populations: A Meta- ... In adults with ADHD, amphetamine-XR trials revealed no changes in the expected safety profile. Common TEAEs included insomnia, dry mouth, and ...

9. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-safety-review-update-medications-used-treat-attention

Safety Review Update of Medications used to treat ADHD Study findings reported no evidence of increased risk of serious cardiovascular effects among children and young people who use ADHD medications.