← Back to Search

Other

Stimulant vs Non-stimulant Treatments for ADHD (MPH-ATX Trial)

Phase 4
Recruiting
Led By Iliyan Ivanov, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pre-pubertal (e.g. Tanner stage 1 or 2)
Age 7-12 inclusive
Must not have
Psychological or medical condition which precludes being in the scanner (e.g., claustrophobia, morbid obesity)
Major neurological/medical illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

This trial will study how well ADHD medications work in kids with ADHD who also have ODD or CD. They will use fMRI to look at the reward systems in their brains.

Who is the study for?
This trial is for children aged 7-12 with ADHD, who may also have ODD or CD. They must be drug-naive to stimulants, pre-pubertal, and able to undergo fMRI scans without issues like claustrophobia. Children with a history of significant head injury, substance exposure in utero, suicidal behavior, low IQ (<75), major psychiatric disorders other than ADHD/ODD/CD or metal implants that can't be removed are excluded.
What is being tested?
The study is testing the effects of two FDA-approved medications for ADHD: Atomoxetine (a non-stimulant) and Methylphenidate (a stimulant). It aims to see how these drugs affect brain reward systems in youth with ADHD by using fMRI imaging technology.
What are the potential side effects?
Possible side effects from Atomoxetine include stomach upset, decreased appetite, nausea/vomiting and mood swings. Methylphenidate may cause nervousness/restlessness, difficulty sleeping, loss of appetite and increased heart rate/blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am in the early stages of puberty.
Select...
I am between 7 and 12 years old.
Select...
I can communicate in English well enough to understand and sign consent forms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I don't have conditions like severe fear of enclosed spaces or extreme obesity that prevent me from undergoing scans.
Select...
I do not have any major neurological or medical illnesses.
Select...
I have been diagnosed with a major psychiatric disorder.
Select...
I have vision problems that could affect my ability to perform tasks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
fMRI Measure

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: MethylphenidateActive Control1 Intervention
0.5 mg/kg for 1 week and 1 mg/kg for 2 weeks
Group II: AtomoxetineActive Control1 Intervention
0.5 mg/kg for 1 week and 1 mg/kg for 2 weeks

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,607 Previous Clinical Trials
3,329,771 Total Patients Enrolled
17 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
2,400 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Icahn School of Medicine at Mount SinaiLead Sponsor
914 Previous Clinical Trials
570,835 Total Patients Enrolled
8 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,181 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Iliyan Ivanov, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
33 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
33 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Jeffrey Newcorn, MDPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
7 Previous Clinical Trials
1,107 Total Patients Enrolled
7 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,107 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Media Library

Atomoxetine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03781765 — Phase 4
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Methylphenidate, Atomoxetine
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Atomoxetine Highlights & Side Effects. Trial Name: NCT03781765 — Phase 4
Atomoxetine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03781765 — Phase 4
~5 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top