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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guanfacine
Lisdexamfetamine
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Intuniv, Non-stimulant, Guanfacine extended-release, Vyvanse, Stimulant, Lisdexamfetamine

Eligibility Criteria

6 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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 Criteria:

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).

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Guanfacine

Lisdexamfetamine

Arm Description

Participants will be administered extended-release guanfacine, which is in tablet form, and will be instructed to take the medication once daily for 6 weeks. The daily dose will range between 1 and 4 mg.

Participants will be administered lisdexamfetamine, which is in tablet form, and will be instructed to take the medication daily for 6 weeks. The daily dose will range between 30 and 70mg.

Outcomes

Primary Outcome Measures

Changes in Brain Segmentation Volume Produced by Stimulant or Non-stimulant Medications in Patients With ADHD
Brain segmentation volume measured in mm^3. We are reporting the mean difference in brain segmentation volume from baseline (pre-test) to 6 weeks (post-test). No statistical analysis information is being submitted for the affected outcome measure. No statistical analyses have been performed or would be considered scientifically appropriate because actual enrollment fell well below target enrollment. Enrollment terminated early as a result of the COVID-19 pandemic.

Secondary Outcome Measures

Full Information

First Posted
September 30, 2014
Last Updated
January 18, 2023
Sponsor
New York State Psychiatric Institute
Collaborators
Columbia University, American Academy of Child Adolescent Psychiatry., Shire
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1. Study Identification

Unique Protocol Identification Number
NCT02259517
Brief Title
An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD
Official Title
Imaging Stimulant vs. Non-Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Recruitment/enrollment ended early due to the COVID-19 pandemic
Study Start Date
September 2014 (Actual)
Primary Completion Date
November 6, 2021 (Actual)
Study Completion Date
November 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Columbia University, American Academy of Child Adolescent Psychiatry., Shire

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.
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 whether brain functioning of children with ADHD differs from that of healthy children. In the second part of the study, the children with ADHD will meet weekly with the study doctor and be administered either extended-release guanfacine (Intuniv) or lisdexamfetamine (Vyvanse) for 6 weeks. Selection into either treatment group will be randomly determined. At the end of the study, the children with ADHD treated with either medication will have a second MRI scan. The findings of that second MRI scan will be compared to the first MRI scan in order to examine brain changes due to the medication. These second MRI scans will also be compared to the scans of the healthy controls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Intuniv, Non-stimulant, Guanfacine extended-release, Vyvanse, Stimulant, Lisdexamfetamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guanfacine
Arm Type
Experimental
Arm Description
Participants will be administered extended-release guanfacine, which is in tablet form, and will be instructed to take the medication once daily for 6 weeks. The daily dose will range between 1 and 4 mg.
Arm Title
Lisdexamfetamine
Arm Type
Experimental
Arm Description
Participants will be administered lisdexamfetamine, which is in tablet form, and will be instructed to take the medication daily for 6 weeks. The daily dose will range between 30 and 70mg.
Intervention Type
Drug
Intervention Name(s)
Guanfacine
Other Intervention Name(s)
Intuniv, GXR
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lisdexamfetamine
Other Intervention Name(s)
Vyvanse, LDX
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Brain Segmentation Volume Produced by Stimulant or Non-stimulant Medications in Patients With ADHD
Description
Brain segmentation volume measured in mm^3. We are reporting the mean difference in brain segmentation volume from baseline (pre-test) to 6 weeks (post-test). No statistical analysis information is being submitted for the affected outcome measure. No statistical analyses have been performed or would be considered scientifically appropriate because actual enrollment fell well below target enrollment. Enrollment terminated early as a result of the COVID-19 pandemic.
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Posner, MD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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