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

NCT02259517 | Terminated Results DMC

• 1 other identifier: 6961
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Intuniv; Non-stimulant; Guanfacine extended-release; Vyvanse; Stimulant; Lisdexamfetamine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Guanfacine

EXPERIMENTAL

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.

Drug: Guanfacine

Lisdexamfetamine

EXPERIMENTAL

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.

Drug: Lisdexamfetamine

Interventions

Guanfacine 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.

Also known as: Intuniv, GXR

Guanfacine

Lisdexamfetamine 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.

Also known as: Vyvanse, LDX

Lisdexamfetamine

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Columbia University: collaborator
• American Academy of Child Adolescent Psychiatry.: collaborator
• Shire: collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Guanfacine; Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines

Limitations and Caveats

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.

Results Point of Contact

• Title: Jonathan Posner, MD
• Organization: Duke University

jonathan.posner@duke.edu

1 919 684 2403

Study Officials

• Jonathan Posner, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 8, 2014
• Study Start: September 1, 2014
• Primary Completion: November 6, 2021
• Study Completion: November 6, 2021
• Last Updated: February 2, 2023
• Results First Posted: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)