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

NCT02259517 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2023-02-02

Study results available
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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 Vyvanse (lisdexamfetamine, LDX), and the non-stimulant Intuniv (extended-release guanfacine, GXR), are both FDA approved treatment for ADHD. Clinical trials have shown that both medications are effective in reducing ADHD symptoms, although the neurobiological mechanisms by which Vyvanse and Intuniv produce these effects remain unknown. The aim of this study is to examine the mechanisms by which LDX and GXR reduce symptoms in patients with ADHD. MRI scanning will be used to identify treatment-related changes in brain structure and function.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

Guanfacine

Participants will meet with the study doctor on a weekly basis during the treatment phase of the study. In the first few weeks, the daily dose of the medication will be individually adjusted by the study doctor according to participants' clinical response to and tolerability of the medication. The optimal dose will then be maintained for the remainder of the treatment period.

DRUG

Lisdexamfetamine

Participants will meet with the study doctor on a weekly basis during the treatment phase of the study. In the first few weeks, the daily dose of the medication will be individually adjusted by the study doctor according to participants' clinical response to and tolerability of the medication. The optimal dose will then be maintained for the remainder of the treatment period.

Sponsors & Collaborators

  • Columbia University

    collaborator OTHER

  • American Academy of Child Adolescent Psychiatry.

    collaborator OTHER

  • Shire

    collaborator INDUSTRY

  • New York State Psychiatric Institute

    lead OTHER

Principal Investigators

  • Jonathan Posner, MD · New York State Psychiatric Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2021-11-06
Completion
2021-11-06

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02259517 on ClinicalTrials.gov