An interventional study of Guanfacine and Lisdexamfetamine in Attention Deficit Hyperactivity Disorder, sponsored by New York State Psychiatric Institute. Terminated at 1 site in United States. Open to participants aged 6 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-02.
Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Treatment
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.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's enrollment of 38 is below the median of 80 across 583 interventional studies indexed under Hyperkinesis.
Browse Hyperkinesis studies →New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
ADHD Participants:
Healthy Control Participants:
All Participants:
Exclusion Criteria:
ADHD Participants:
Healthy Controls:
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 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.
Also known as: 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.
Also known as: Vyvanse, LDX
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.
Time frame: Baseline and 6 weeks
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.
| Milestone | ADHD - Guanfacine | ADHD - Lisdexamfetamine | Healthy Controls |
|---|---|---|---|
| Started | 5 | 4 | 24 |
| Completed | 5 | 4 | 15 |
| Not completed | 0 | 0 | 9 |
| Withdrew: Psychiatric diagnosis (e.g., adhd, mdd) | 0 | 0 | 6 |
| Withdrew: Withdrawal by subject | 0 | 0 | 3 |
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.
| mm^3 | ADHD - Guanfacine | ADHD - Lisdexamfetamine |
|---|---|---|
| Changes in Brain Segmentation Volume Produced by Stimulant or Non-stimulant Medications in Patients With ADHD | -6137 ± 14393 | 11833 ± 39942 |
Collected over Adverse event data were collected through study completion, an average of 6 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Guanfacine | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Lisdexamfetamine | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
Baseline analysis population includes participants who completed the study.
| Age, Continuous(years) | ADHD - Guanfacine | ADHD - Lisdexamfetamine | Healthy Controls | Total |
|---|---|---|---|---|
| Mean | 10 ± 2.35 | 8.75 ± 0.96 | 9.6 ± 2.47 | 9.54 ± 2.23 |
| Sex: Female, Male(Participants) | ADHD - Guanfacine | ADHD - Lisdexamfetamine | Healthy Controls | Total |
|---|---|---|---|---|
| Female | 1 | 1 | 8 | 10 |
| Male | 4 | 3 | 7 | 14 |
| Ethnicity (NIH/OMB)(Participants) | ADHD - Guanfacine | ADHD - Lisdexamfetamine | Healthy Controls | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 5 | 7 |
| Not Hispanic or Latino | 2 | 1 | 1 | 4 |
| Unknown or Not Reported | 2 | 2 | 9 | 13 |
| Race (NIH/OMB)(Participants) | ADHD - Guanfacine | ADHD - Lisdexamfetamine | Healthy Controls | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 8 | 10 |
| White | 2 | 2 | 3 | 7 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 4 | 6 |
| Behavior Rating Inventory of Executive Function, 2nd Edition - Global Executive Composite(T-score) | ADHD - Guanfacine | ADHD - Lisdexamfetamine | Healthy Controls | Total |
|---|---|---|---|---|
| Mean | 65.33 ± 7.77 | 62.5 ± 9.33 | 44.57 ± 12.38 | 52.22 ± 14.47 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
New York State Psychiatric Institute