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Stimulant vs Non-stimulant Treatments for ADHD (MPH-ATX Trial)
Phase 4
Recruiting
Led By Jeffrey Newcorn, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights
MPH-ATX Trial 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.Check my eligibility
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.See study design
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.
MPH-ATX Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am in the early stages of puberty.
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I am between 7 and 12 years old.
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I can communicate in English well enough to understand and sign consent forms.
MPH-ATX Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
fMRI Measure
MPH-ATX 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
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Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,465 Previous Clinical Trials
2,618,589 Total Patients Enrolled
17 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
2,411 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,242 Total Patients Enrolled
8 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,130 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
1,118 Total Patients Enrolled
7 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,118 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have metal in your body that cannot be taken out, like braces or a metal plate.I have not taken stimulant medications recently, but non-stimulants are okay.I don't have conditions like severe fear of enclosed spaces or extreme obesity that prevent me from undergoing scans.You were exposed to alcohol or drugs before you were born.I am in the early stages of puberty.I am between 7 and 12 years old.I do not have any major neurological or medical illnesses.You have thoughts of hurting yourself or have tried to harm yourself in the past.You have a severe behavioral disorder called Conduct Disorder (CD) or Oppositional Defiant Disorder (ODD). You also have at least two symptoms of CD as determined by a specific assessment tool called C-DISC.You have started puberty too early or you are currently pregnant.I have been diagnosed with a major psychiatric disorder.I can communicate in English well enough to understand and sign consent forms.You have had a previous injury to your head.I have vision problems that could affect my ability to perform tasks.
Research Study Groups:
This trial has the following groups:- Group 1: Methylphenidate
- Group 2: Atomoxetine
Awards:
This trial has 3 awards, including:- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does Atomoxetine present any adverse risks to users?
"Atomoxetine has been approved for use after thorough testing, so it is given a rating of 3 on our safety scale."
Answered by AI
Is the age bracket for this experiment limited to adults or is it open to all ages?
"The age range for enrolment into this clinical trial is between 7 and 12. Furthermore, there are 120 slots available to those below 18 years of age, as well as 53 spots open to adults over 65."
Answered by AI
Is enrollment still open for participation in this experiment?
"To qualify for this trial, applicants must have a diagnosis of ADHD and be aged between 7 and 12. Accommodating 44 children in total, this study is now open for enrolment."
Answered by AI
What is the participation level of this trial?
"Affirmative. Clinicaltrials.gov's records show that this experiment, which was initially advertised on June 4th 2019, is presently signing up patients. The trial requires 44 people to come from 1 specific site in order to be successful."
Answered by AI
Could you elaborate on previous experiments utilizing Atomoxetine?
"Currently, 39 Atomoxetine studies are ongoing with 4 of them being in Phase 3. While the majority of these investigations originate from Houston, Texas, a wide network spanning 126 sites is working to advance this medication's development."
Answered by AI
Are there any open opportunities for participants to join this clinical trial?
"Clinical trials.gov states that this research endeavour is currently recruiting participants, having first been posted on June 4th 2019 and updated April 5th 2022."
Answered by AI
Who else is applying?
What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Met criteria
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