Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk
Recruiting · NCT03781765 · Interventional (participants receive a specific treatment) · Lead sponsor: Icahn School of Medicine at Mount Sinai
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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.
Who can take part
Age range
7 Years to 12 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Icahn School of Medicine at Mount Sinai - New York, New York, United States