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

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT03781765
Phase
PHASE4
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
7 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Methylphenidate — DRUG
    stimulant medication
  • Atomoxetine — DRUG
    non-stimulant medication

Study Details

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.

Key Dates

Start date
Jun 4, 2019
Status verified
Aug 2024
Primary completion
Sep 25, 2025
Completion
Sep 25, 2025

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

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

Primary Outcome Measure

fMRI Measure [ Time Frame: 3 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Beth Krone, PhD
212-241-8012
Jeffrey Newcorn, MD (PRINCIPAL_INVESTIGATOR)
Iliyan Ivanov, MD (PRINCIPAL_INVESTIGATOR)

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