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Status:

TERMINATED

An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD

Lead Sponsor:

New York State Psychiatric Institute

Collaborating Sponsors:

Columbia University

American Academy of Child Adolescent Psychiatry.

Conditions:

Attention Deficit Hyperactivity Disorder

Eligibility:

All Genders

6-17 years

Phase:

NA

Brief Summary

Children with Attention-Deficit/Hyperactivity Disorder (ADHD) are typically treated with two types of medications with differing mechanisms of action: stimulants and non-stimulants. The stimulant Vyva...

Detailed Description

Children with ADHD and age and sex-matched healthy controls will be scanned at the beginning of the study. In this first part of the study, MRI findings will be compared between the two groups to see ...

Eligibility Criteria

Inclusion

  • ADHD Participants:
  • The participant satisfies Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a primary diagnosis of ADHD, any subtype.
  • Healthy Control Participants:
  • The participant must have no current DSM Axis I psychiatric disorder.
  • All Participants:
  • Participants must provide assent and a legal guardian must provide consent.
  • The participant is male or female and between 6 - 17 years of age and in good physical health.
  • Girls of childbearing potential must have a negative urine pregnancy test and, if sexually active, must be using adequate contraception.
  • The participant is English speaking.

Exclusion

  • ADHD Participants:
  • The participant has a current comorbid DSM Axis I psychiatric diagnosis or other symptomatic manifestations that, in the opinion of the study doctor, will contraindicate lisdexamfetamine or guanfacine treatment or confound safety assessments.
  • The participant meets DSM-5 criteria for current substance abuse and/or dependence.
  • The participant is currently taking or has taken within the past 4 months, a psychotropic medication.
  • The participant has a documented allergy or intolerance to lisdexamfetamine or guanfacine products.
  • The participant has a diagnosis or a history of cardiovascular disease or any other serious medical illness.
  • The participant is pregnant or lactating.
  • The participant is actively suicidal.
  • MRI contraindications (e.g., irremovable metal on the body, pacemaker, braces)
  • The participant has a full-scale intelligence quotient (IQ) less than 70.
  • The participant has a history of seizure (except febrile seizure).
  • Healthy Controls:
  • The participant meets DSM criteria for current substance abuse and/or dependence.
  • The participant is currently taking a psychotropic medication.
  • The participant has a history of a serious medical illness.
  • The participant is pregnant or lactating.
  • MRI contraindications (e.g., irremovable metal on the body, pacemaker, braces)
  • The participant has a full-scale intelligence quotient (IQ) less than 70.
  • The participant has a history of seizure (except febrile seizure).

Key Trial Info

Start Date :

September 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 6 2021

Estimated Enrollment :

38 Patients enrolled

Trial Details

Trial ID

NCT02259517

Start Date

September 1 2014

End Date

November 6 2021

Last Update

February 2 2023

Active Locations (1)

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New York State Psychiatric Institute

New York, New York, United States, 10032