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

NCT ID: NCT02259517

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2021-11-06

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Guanfacine

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.

Group Type: EXPERIMENTAL

Guanfacine

Intervention Type: DRUG

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 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.

Group Type: EXPERIMENTAL

Lisdexamfetamine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Intuniv; GXR; Vyvanse; LDX

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).

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Columbia University

OTHER

Sponsor Role: collaborator

American Academy of Child Adolescent Psychiatry.

OTHER

Sponsor Role: collaborator

Shire

INDUSTRY

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Posner

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Posner, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

6961

Identifier Type: -

Identifier Source: org_study_id