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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Imaging Stimulant vs. Non-Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02259517
• Other study ID #: 6961
• Status: Terminated
• Phase: N/A
• Start date: September 2014
• Est. completion date: November 6, 2021

Study information

• Verified date: January 2023
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: November 6, 2021
• Est. primary completion date: November 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	American Academy of Child Adolescent Psychiatry., Columbia University, Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 6 weeks