Trial Outcomes & Findings for An fMRI Study of Stimulant vs. Non-Stimulant Treatment of ADHD (NCT NCT02259517)
NCT ID: NCT02259517
Last Updated: 2023-02-02
Results Overview
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.
TERMINATED
NA
38 participants
Baseline and 6 weeks
2023-02-02
Participant Flow
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.
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.
Participant milestones
| Measure |
ADHD - Guanfacine
ADHD participants who were randomized to receive guanfacine for 6 weeks of treatment
|
ADHD - Lisdexamfetamine
ADHD participants who were randomized to receive lisdexamfetamine for 6 weeks of treatment
|
Healthy Controls
Age- and sex- matched healthy control participants; baseline procedures only
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
24
|
|
Overall Study
COMPLETED
|
5
|
4
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
9
|
Reasons for withdrawal
| Measure |
ADHD - Guanfacine
ADHD participants who were randomized to receive guanfacine for 6 weeks of treatment
|
ADHD - Lisdexamfetamine
ADHD participants who were randomized to receive lisdexamfetamine for 6 weeks of treatment
|
Healthy Controls
Age- and sex- matched healthy control participants; baseline procedures only
|
|---|---|---|---|
|
Overall Study
Psychiatric diagnosis (e.g., ADHD, MDD)
|
0
|
0
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
3
|
Baseline Characteristics
One Healthy Control participant was missing the parent-report BRIEF-2.
Baseline characteristics by cohort
| Measure |
ADHD - Guanfacine
n=5 Participants
ADHD participants who were randomized to receive guanfacine for 6 weeks of treatment
|
ADHD - Lisdexamfetamine
n=4 Participants
ADHD participants who were randomized to receive lisdexamfetamine for 6 weeks of treatment
|
Healthy Controls
n=15 Participants
Age- and sex- matched healthy control participants; baseline procedures only
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
10 years
STANDARD_DEVIATION 2.35 • n=5 Participants
|
8.75 years
STANDARD_DEVIATION 0.96 • n=4 Participants
|
9.6 years
STANDARD_DEVIATION 2.47 • n=15 Participants
|
9.54 years
STANDARD_DEVIATION 2.23 • n=24 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=15 Participants
|
10 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=15 Participants
|
14 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=15 Participants
|
7 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=15 Participants
|
4 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=15 Participants
|
13 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=15 Participants
|
10 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=15 Participants
|
7 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=15 Participants
|
6 Participants
n=24 Participants
|
|
Behavior Rating Inventory of Executive Function, 2nd Edition - Global Executive Composite
|
65.33 T-score
STANDARD_DEVIATION 7.77 • n=5 Participants • One Healthy Control participant was missing the parent-report BRIEF-2.
|
62.5 T-score
STANDARD_DEVIATION 9.33 • n=4 Participants • One Healthy Control participant was missing the parent-report BRIEF-2.
|
44.57 T-score
STANDARD_DEVIATION 12.38 • n=14 Participants • One Healthy Control participant was missing the parent-report BRIEF-2.
|
52.22 T-score
STANDARD_DEVIATION 14.47 • n=23 Participants • One Healthy Control participant was missing the parent-report BRIEF-2.
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksPopulation: 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.
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.
Outcome measures
| Measure |
ADHD - Guanfacine
n=4 Participants
ADHD participants who were randomized to receive guanfacine for 6 weeks of treatment
|
ADHD - Lisdexamfetamine
n=3 Participants
ADHD participants who were randomized to receive lisdexamfetamine for 6 weeks of treatment
|
|---|---|---|
|
Changes in Brain Segmentation Volume Produced by Stimulant or Non-stimulant Medications in Patients With ADHD
|
-6137 mm^3
Standard Deviation 14393
|
11833 mm^3
Standard Deviation 39942
|
Adverse Events
Guanfacine
Lisdexamfetamine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place