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

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ClinicalTrials.gov Identifier: NCT02259517
Recruitment Status : Recruiting
First Posted : October 8, 2014
Last Update Posted : July 9, 2019
Sponsor:
Collaborators:
Columbia University
American Academy of Child Adolescent Psychiatry.
Shire
Information provided by (Responsible Party):
Jonathan Posner, New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Guanfacine Drug: Lisdexamfetamine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Imaging Stimulant vs. Non-Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
Study Start Date : September 2014
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
Experimental: 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.
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.
Other Names:
  • Intuniv
  • GXR

Experimental: 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.
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.
Other Names:
  • Vyvanse
  • LDX




Primary Outcome Measures :
  1. Changes in brain structure and function produced by stimulant or non-stimulant medications in patients with ADHD [ Time Frame: Baseline and 6 weeks ]
    MRI (Magnetic Resonance Imaging)



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259517


Contacts
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Contact: Jonathan Posner, MD 646-774-5735 PosnerJ@nyspi.columbia.edu

Locations
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United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Jonathan Posner, MD    646-774-5735    PosnerJ@nyspi.columbia.edu   
Principal Investigator: Jonathan Posner, MD         
Sponsors and Collaborators
New York State Psychiatric Institute
Columbia University
American Academy of Child Adolescent Psychiatry.
Shire
Investigators
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Principal Investigator: Jonathan Posner, MD New York State Psychiatric Institute

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Responsible Party: Jonathan Posner, Associate Professor, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT02259517     History of Changes
Other Study ID Numbers: 6961
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jonathan Posner, New York State Psychiatric Institute:
ADHD
Intuniv
Non-stimulant
Guanfacine extended-release
Vyvanse
Stimulant
Lisdexamfetamine
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Guanfacine
Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents