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Stimulant vs. Non-stimulant Treatments and Reward Processing in Youth with ADHD

This study is looking at how two common ADHD medications, methylphenidate (a stimulant) and atomoxetine (a non-stimulant), affect the brain's reward system in children with ADHD. Researchers want to understand if these medications change how the brain processes rewards, especially in children who might be at higher risk for substance use problems later in life. You can join if you are 7-12 years old, have ADHD, and meet other specific criteria. The main goal is to measure brain activity related to reward processing using fMRI (functional magnetic resonance imaging) after 3 weeks of treatment. The study is currently unclear about its recruitment status and aims to enroll 44 participants.

Study design
This is an interventional study planning to enroll 44 participants. It compares the effects of methylphenidate and atomoxetine.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 3 weeks, which suggests a short-term follow-up for this specific measurement.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03781765

Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk

Recruiting
PHASE4Ages 7–12InterventionalBasic science
Icahn School of Medicine at Mount Sinai
~44 participants
Updated 2024-08-09 on ClinicalTrials.gov
What's tested:MethylphenidateAtomoxetine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
fMRI Measure
Measured over 3 Weeks

Conditions

ADHD
Attention Deficit Hyperactivity Disorder

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Attention Deficit Hyperactivity DisorderConduct DisorderOppositional Defiant Disorder

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Jeffrey Newcorn, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
  • Iliyan Ivanov, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Beth Krone, PhD
[email protected]
212-241-8012
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Pre-pubertal (e.g. Tanner stage 1 or 2)
Age 7-12 inclusive
Signed consent/assent
Parent communicates sufficiently in English to provide informed consent and complete assessment instruments;
ADHD as determined by computerized DISC (C-DISC) parent interview
ADHD-Rating Scale-5 total score (interview with parent )
SNAP ADHD total score (teacher) of 1.5 SD \> age/sex norms
CD or severe ODD: CD or ODD + 2 symptoms of CD on C-DISC
SNAP ODD/CD subscale (parent and teacher) 1.5 SD \> age/sex norms

Exclusion

Major neurological/medical illness
History of head injury
Fetal exposure to alcohol/drugs
Diagnosis of major psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depression, generalized anxiety, social phobia, Tourette's Disorder, PTSD, autism spectrum disorder)
Current suicidal ideation or past history of suicide attempt
Wechsler Abbreviated Scale of Intelligence (WASI)75 score \<75
Prior or current treatment with stimulants (prior or current treatment with non-stimulants is permitted, but participants must be off medication for 2 weeks at baseline)
Current or past alcohol/drug use (DISC interview; urine toxicology)
Psychological or medical condition which precludes being in the scanner (e.g., claustrophobia, morbid obesity)
Metal in the body that cannot be removed (e.g., braces, metal plate)
Visual disturbances that may impair task performance
Precocious puberty (e.g. Tanner stage \>2) or pregnancy
History of SUD in a 1st degree relative is permitted, and is expected in \~1/2 of the subjects
Ongoing psychosocial treatment is allowed but should not be initiated during the study

What this trial measures

  • fMRI Measure3 Weeks

    Bold activation change within the reward system (e.g., ventral striatum, insula and orbitofrontal cortex)