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

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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 it safe to use ADHD medications like Concerta and Adderall-XR?

ADHD medications, including Concerta, have been studied for safety, but concerns remain about potential side effects, such as minor issues and serious risks like heart problems and suicidal thoughts. It's important to monitor for side effects and educate patients about recognizing any changes. ^{1 2 3 4 5}

How is the drug Concerta unique for treating ADHD?

Concerta is unique because it is an extended-release form of methylphenidate, which means it provides a steady release of medication throughout the day with just one dose, improving attention and behavior in both children and adults with ADHD. ^{2 6 7 8 9}

What data supports the effectiveness of the drug Adderall-XR and Concerta for treating ADHD?

Research shows that Concerta, a form of methylphenidate, is effective in improving attention, behavior, and cognitive function in children with ADHD. Studies indicate that it is well-tolerated and leads to significant improvements in symptoms, as reported by parents, teachers, and through cognitive tests. ^{1 6 7 10 11}

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 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]

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 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]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, cross-over, phase IV trial of oros-methylphenidate (CONCERTA(®)) and generic novo-methylphenidate ER-C (NOVO-generic). [2020]

2. Germany 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of OROS methylphenidate in Korean children with attention-deficit/hyperactivity disorder. [2013]

4. China pubmed.ncbi.nlm.nih.gov

[Effect of extended-release methylphenidate on the ecological executive function for attention deficit hyperactivity disorder]. [2017]

5. Germany pubmed.ncbi.nlm.nih.gov

Cognitive versus behavioral ADHD phenotype: what is it all about? [2015]

6. United States 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. [2022]

7. New Zealand 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. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

European guidelines on managing adverse effects of medication for ADHD. [2022]

9. Ireland 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. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

[Switching from a short-acting to a long-acting methylphenidate preparation: a multicentre, open study in children with ADHD]. [2013]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Effect of switching drug formulations from immediate-release to extended-release OROS methylphenidate : a chart review of Spanish adults with attention-deficit hyperactivity disorder. [2022]