Personalized Medication for ADHD

Overseen By William Brinkman, MD, MEd, MSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Must be taking: Stimulants

Disqualifiers: No internet access, No texting

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

Compensation: Varies

Number of Visits: 3

Duration: 4-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how personalized ADHD medication plans can help adolescents make better treatment choices in the future. The goal is to determine if these tailored plans can increase teens' involvement in treatment decisions and reduce uncertainty about continuing medication. Participants will select from various medication options to find what works best for them. The trial is ideal for adolescents aged 11-15 who have been treated for ADHD for over a year and are uncertain about continuing their current medication. As an unphased trial, this study offers a unique opportunity for participants to actively shape their treatment journey and contribute to innovative ADHD care strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on testing personalized medication approaches, so you might continue your current treatment, but it's best to ask the trial organizers for details.

Is there any evidence suggesting that the personalized ADHD medication experiment is likely to be safe?

Research shows that ADHD medications are usually well-tolerated. Studies have found that these medications can lower the risk of substance use by 27-35% in the short term, indicating safety for many people. One study found that taking methylphenidate, a common ADHD medication, was safe over two years, with no major safety issues reported. While these findings suggest ADHD medications are safe, individual experiences can differ. Always consult a healthcare provider about any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this personalized ADHD medication because it offers a tailored approach, unlike the current standard treatments such as stimulants like Adderall or Ritalin, and non-stimulants like Strattera. This experimental treatment allows individuals to choose from five different medication options, potentially matching the treatment more closely with their unique needs and symptoms. By personalizing medication choices, this approach aims to improve effectiveness and reduce side effects, addressing the common issue of trial-and-error in finding the right ADHD treatment. This customization could lead to better management of ADHD symptoms and enhance the overall quality of life for those affected.

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

Research has shown that ADHD medications effectively reduce key symptoms like inattention and hyperactivity. Studies indicate that about 70% of children respond well to stimulant medications, commonly used to treat ADHD. In this trial, participants will choose one of five medication options as part of a personalized approach, potentially improving results by selecting medications based on individual needs. Open-label trials suggest that tailoring medications to each person can be a promising strategy for teenagers with ADHD. This method aims to involve patients more in treatment decisions and reduce uncertainty about using medication. ^{2 3 5 6 7}

Who Is on the Research Team?

William Brinkman, MD, MEd, MSc

Principal Investigator

Cincinnati Children's

Are You a Good Fit for This Trial?

This trial is for adolescents with ADHD who are interested in exploring how personalized medication can affect their condition. It's a pilot study, meaning it's an early test to see if the approach works and is accepted by participants.

Inclusion Criteria

I am a teenager and I have agreed in writing to join the study.

Uncertainty about continued ADHD medication use

A parent or legal guardian must provide written informed consent

Exclusion Criteria

Do not have reliable access to the internet at their home or another location

Will not permit their child to access the internet for study related activities

Are not able or willing to send or receive text messages.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants choose one of five medication experiments to complete and track effects

4-12 weeks

1 visit (in-person)

Follow-up

Participants complete a follow-up study visit to review results and discuss feasibility

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Personalized ADHD Medication Experiment

Trial Overview The study tests a new way of using ADHD medication tailored to each individual. The goal is to involve teens more in decision-making about their treatment and reduce uncertainty regarding future medication use.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

All will choose one of five medication experiment options to complete.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5387107/

Personalized Medication Response Prediction for Attention ... (2013). Around 70% of children demonstrate a clinically significant treatment response to stimulant medication (Spencer et al., 1996; Schachter et al., 2001; ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/78/NCT06305078/Prot_SAP_000.pdf

Open-Label Trial of personalized medication experiments ... ABSTRACT: Medication is an efficacious treatment strategy for adolescents with attention- deficit/hyperactivity disorder (ADHD);1 however, use significantly ...

3. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2835661

Increased Prescribing of Attention-Deficit/Hyperactivity ... Randomized clinical trials have demonstrated that ADHD medications are effective in reducing core ADHD symptoms and large observational studies ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0149763424002434

Treatments in the pipeline for attention-deficit/hyperactivity ... The study showed that active TSM did not significantly improve ADHD symptoms, as measured by the Conners Adult ADHD Rating Scale—Self-Report: Long Version (t- ...

5. jaacap.org jaacap.org/article/S0890-8567(24)00304-6/fulltext

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6697582/

Risks and benefits of ADHD medication on behavioral ... Two studies investigating short-term effects using within-individual designs reported that ADHD medication was associated with 27–35% reduced risk of substance ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2215036623000421

Long-term safety of methylphenidate in children and ... Our results suggest that long-term treatment with methylphenidate for 2 years is safe. There was no evidence to support the hypothesis that methylphenidate ...