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Recruitment/enrollment ended early due to the COVID-19 pandemic
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| Name | Class |
|---|---|
| Columbia University | OTHER |
| American Academy of Child Adolescent Psychiatry. | OTHER |
| Shire | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
ADHD Participants:
Healthy Control Participants:
All Participants:
Exclusion Criteria:
ADHD Participants:
Healthy Controls:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Posner, MD | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
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5 ADHD participants withdrew or were excluded from the study prior to randomization and thus are not included. Participants who withdrew were no longer interested in treatment or were lost to follow-up. Participants were excluded due to subthreshold ADHD symptoms, comorbid psychiatric conditions, & MRI contraindications.
Recruitment started in 2014 and ended in 2020. Participants were primarily recruited from the community through advertisements in local newspapers and flyers posted in local establishments. Participants were also recruited from other research studies and doctor's offices.
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| ID | Title | Description |
|---|---|---|
| FG000 | ADHD - Guanfacine | ADHD participants who were randomized to receive guanfacine for 6 weeks of treatment |
| FG001 | ADHD - Lisdexamfetamine | ADHD participants who were randomized to receive lisdexamfetamine for 6 weeks of treatment |
| FG002 | Healthy Controls | Age- and sex- matched healthy control participants; baseline procedures only |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analysis population includes participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | ADHD - Guanfacine | ADHD participants who were randomized to receive guanfacine for 6 weeks of treatment |
| BG001 | ADHD - Lisdexamfetamine | ADHD participants who were randomized to receive lisdexamfetamine for 6 weeks of treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 4 subjects from the ADHD-Guanfacine group and 3 subjects from the ADHD-Lisdexamfetamine group had usable anatomical MRI data at baseline and follow-up. HCs did not complete follow-up. 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. | Posted | Mean | Standard Deviation | mm^3 | Baseline and 6 weeks |
|
Adverse event data were collected through study completion, an average of 6 weeks.
Adverse events were routinely collected from ADHD participants receiving treatment using the Pittsburgh Side Effects Rating Scale. A physician met with participants in person approximately once per week during treatment. The physician was also available by phone between visits.
HC participants completed a baseline assessment and did not receive any intervention; therefore, there was no monitoring for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Posner, MD | Duke University | 1 919 684 2403 | jonathan.posner@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 10, 2020 | Oct 4, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 10, 2020 | Jan 18, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D016316 | Guanfacine |
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D010648 | Phenylacetates |
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|
|
| 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. |
|
|
| BG002 | Healthy Controls | Age- and sex- matched healthy control participants; baseline procedures only |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Behavior Rating Inventory of Executive Function, 2nd Edition - Global Executive Composite | The Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) assesses executive function in children and adolescents ages 5-18 years old. The Global Executive Composite (GEC) is an overall summary score and reflects all the clinical scales of the BRIEF-2. Higher scores indicate lower levels of executive functioning. Parent-report T-scores on the GEC are reported below (population mean = 50, population standard deviation = 10). | One Healthy Control participant was missing the parent-report BRIEF-2. | Mean | Standard Deviation | T-score |
|
| Description |
|---|
| OG000 | ADHD - Guanfacine | ADHD participants who were randomized to receive guanfacine for 6 weeks of treatment |
| OG001 | ADHD - Lisdexamfetamine | ADHD participants who were randomized to receive lisdexamfetamine for 6 weeks of treatment |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | 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. 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. | 0 | 4 | 0 | 4 | 0 | 4 |
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| D000146 |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|