NCT03781765 · Icahn School of Medicine at Mount Sinai
Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk
(MPH-ATX)
What this study is about
The study team will examine the effects of FDA approved stimulant and non-stimulant medications for ADHD, among youth with ADHD and with and without Oppositional Defiant Disorder (ODD) or Conduct Disorder (CD), on reward systems of the brain using fMRI.
View original scientific description
The study team will examine the effects of FDA approved stimulant and non-stimulant medications for ADHD, among youth with ADHD and with and without Oppositional Defiant Disorder (ODD) or Conduct Disorder (CD), on reward systems of the brain using fMRI.
Interventions
DRUG
Methylphenidate
stimulant medication
DRUG
Atomoxetine
non-stimulant medication
Primary outcome measures
fMRI Measure
Time frame: 3 Weeks
Bold activation change within the reward system (e.g., ventral striatum, insula and orbitofrontal cortex)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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 Notes:
- 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
Where
- New York, New York
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 9, 2024 · Source of record for eligibility and locations