Methylphenidate + Amphetamines for ADHD

AB
Overseen ByAnne B Arnett, PhD
Age: < 18
Sex: Any
Trial Phase: Phase 4
Sponsor: Boston Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Pediatric attention deficit hyperactivity disorder (ADHD) affects up to 10% of children in the U.S. and more than 90% are prescribed stimulant medications according to clinical guidelines. The standard of care for pharmacological treatment of ADHD is a "trial-and-error" approach that requires frequent dose adjustments, side effects management, and communication among doctors, parents, and school personnel over weeks, months, and years. In the first year following prescription of stimulant medications, \>50% of doctors are not able to conduct the recommended follow-up with their patients. Many patients stop taking medications or keep taking medications that do not work well, as a result.

This investigation will use a non-invasive brain imaging technique called EEG to look for activity in the brain that can predict which children with ADHD will respond well to two commonly prescribed stimulant medication groups, methylphenidate and amphetamines. Based on a previous study, it is expected that EEG signals can differentiate among children whose ADHD symptoms will get better on methylphenidate, and those whose ADHD symptoms will get better on amphetamines.

220 participants ages 7-11 with ADHD will be enrolled. Participants will not have autism or intellectual disabiltiy. They will not currently be taking psychiatric medications. Participants will not have not taken stimulant medications before or have tried stimulant medications \>6 months or experienced an improvement in their ADHD symptoms by taking a stimulant medication before.

Study Participation Includes:

1. Participant and caregiver complete a 3-hour visit at the Arnett Laboratory at 2 Brookline Place. During this visit, participants complete a brief IQ test and an EEG while their caregiver completes questionnaires and a clinical interview. The caregiver will give permission to request survey responses from the participant's teacher.

2. The next day, the participant and caregiver will come back to the laboratory for a 1-hour visit. The participant will do another EEG while the caregiver fills out more surveys. The doctor will take the participant's vital signs and prescribe the medication.

3. The participant will be randomly assigned to take either methylphenidate HCl or amphetamines every morning for 3 weeks. At the end of each week, the caregiver and teacher will fill out a questionnaire about the participant's behaviors and symptoms, including side effects.

4. For one week, the participant will not take medications. They will come back into the lab for another EEG at the end of that week.

5. The participant will then take the other medication every morning for 3 weeks. At the end of each week, the caregiver and teacher will fill out a questionnaire about the participant's behaviors and symptoms, including side effects.

6. It will take participants about 7 weeks to complete this study. During this time, they will complete 3 in-person and 6 virtual study visits.

7. The research funds will cover cost associated with the study. The participant's health insurer will not be billed for the medications or treatment. Medications will be provided through the research pharmacy.

8. Participants will be given a report at the end of the study with details about the medication trials, symptom response, and any other findings. They will receive up to $270 for the completion of the study. Some travel-related costs will be covered by the study.

Are You a Good Fit for This Trial?

Inclusion Criteria

Willing and able to comply with study procedures
CGI-Severity rating of 4 'Moderately ill' through 6 'Severely ill'
I am between 7 and 10 years old.
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Exclusion Criteria

Fetal alcohol exposure per medical chart review or caregiver report
Current suicidal ideation per caregiver or child report on CSSRS
History of severe side effects to stimulants including suicidality, complete loss of appetite, cardiopulmonary complications per caregiver report or medical chart review, determined by the study MD
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What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Mixed Amphetamines then Methylphenidate HClExperimental Treatment2 Interventions
Group II: Methylphenidate HCl then Mixed AmphetaminesExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+

Seattle Children's Hospital

Collaborator

Trials
319
Recruited
5,232,000+

Tris Pharma, Inc.

Industry Sponsor

Trials
22
Recruited
4,800+