Attention Deficit Hyperactivity DisorderNCT02259517
An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD
A study testing Guanfacine and Lisdexamfetamine in people with Attention Deficit Hyperactivity Disorder, run by New York State Psychiatric Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Guanfacine and Lisdexamfetamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 6 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Imaging Stimulant vs. Non-Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
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.
Read the 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
- Being tested
- Guanfacine, Lisdexamfetamine
- Keywords
- ADHD, Intuniv, Non-stimulant, Guanfacine extended-release, Vyvanse, Stimulant, Lisdexamfetamine
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuanfacineDrug
Also called Intuniv, GXR
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.
LisdexamfetamineDrug
Also called Vyvanse, LDX
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Lisdexamfetamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startSep 2014
- Primary completion6 Nov 2021
- Study completion6 Nov 2021
Why it stopped: Recruitment/enrollment ended early due to the COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, American Academy of Child Adolescent Psychiatry., Shire
- Responsible party
- Principal investigator, Jonathan Posner, New York State Psychiatric Institute
- Investigators
- Jonathan Posner, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259517
- Sponsor's protocol ID
- 6961
- Status last verified
- Jan 2023
- First submitted
- 30 Sep 2014
- Last updated
- 2 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Stimulant vs. Non-Stimulant Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT02259517
- Acronym / sponsor ID
- 6961
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Intuniv, Non-stimulant, Guanfacine extended-release, Vyvanse, Stimulant, Lisdexamfetamine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment/enrollment ended early due to the COVID-19 pandemic
- Enrolment
- 38 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- Columbia University, American Academy of Child Adolescent Psychiatry., Shire
- Study start
- Sep 2014 (actual)
- Primary completion
- 6 Nov 2021 (actual)
- Study completion
- 6 Nov 2021 (actual)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Posted 2 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guanfacine | Experimental | Drug: GuanfacineParticipants 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. |
| Lisdexamfetamine | Experimental | Drug: LisdexamfetamineParticipants 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- The participant satisfies Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a primary diagnosis of ADHD, any subtype.
- The participant must have no current DSM Axis I psychiatric disorder.
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GuanfacineAlso: Intuniv, GXRParticipants 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. | Drug | Guanfacine |
| LisdexamfetamineAlso: Vyvanse, LDXParticipants 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. | Drug | Lisdexamfetamine |
Primary outcome
Changes in Brain Segmentation Volume Produced by Stimulant or Non-stimulant Medications in Patients With ADHD
Time frame: Baseline and 6 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Posner, MD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guanfacine and Lisdexamfetamine in people with Attention Deficit Hyperactivity Disorder, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Brain Segmentation Volume Produced by Stimulant or Non-stimulant Medications in Patients With ADHD (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.