Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk
Recruiting
Phase 4Interventional Study
ADHDAttention Deficit Hyperactivity Disorder
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
7 – 12
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Basic Science
Participants needed
44 (estimated)
Sponsor
Icahn School of Medicine at Mount Sinai · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
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…
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
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