Recruiting

Stimulant vs. Non-stimulant

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT03781765

Conditions

ADHD

Attention Deficit Hyperactivity Disorder

Eligibility Criteria

Sex: All

Age: 7 - 12

Healthy Volunteers: Not accepted

Interventions

Methylphenidate

Atomoxetine

Study Details

Brief summary:

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.

Conditions

ADHD

Attention Deficit Hyperactivity Disorder

Study ID

NCT03781765

Start date

Jun 4, 2019

Status verified date

Aug, 2024

Completion date

Sep 25, 2025

Anticipated

Primary completion date

Sep 25, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 12

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Methylphenidate

0.5 mg/kg for 1 week and 1 mg/kg for 2 weeks

active comparator: Atomoxetine

0.5 mg/kg for 1 week and 1 mg/kg for 2 weeks

Interventions

Methylphenidate

stimulant medication

Atomoxetine

non-stimulant medication

Primary outcome measure

  • fMRI Measure [ Time Frame: 3 Weeks ]

Central Contacts and Locations

Central contacts

Beth Krone, PhD

212-241-8012beth.krone@mssm.edu

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Beth Krone, PhD

212-241-8012beth.krone@mssm.edu

Principal Investigator:

Jeffrey Newcorn, MD

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Aug 9, 2024

Last verified

Aug, 2024

Keywords

  • fMRI Study
  • MPH
  • Methylphenidate
  • ATX
  • Atomoxetine
  • Reward System
  • Substance Abuse Risk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2024-08-09.