Trial Outcomes & Findings for Imaging the Effects of Stimulant Medication on Emotional Lability in Patients With ADHD (NCT NCT01415440)
NCT ID: NCT01415440
Last Updated: 2022-08-02
Results Overview
Brain structure volume measured in mm\^3
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
117 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-08-02
Participant Flow
Recruitment started in 2011 and ended in 2018. 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.
18 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 |
Healthy Control
Baseline evaluation only
|
ADHD - Placebo
ADHD participants randomized to receive placebo for 12 weeks of treatment
|
ADHD - Vyvanse
ADHD participants randomized to receive 12 weeks of medication treatment with Vyvanse
|
|---|---|---|---|
|
Overall Study
STARTED
|
41
|
29
|
29
|
|
Overall Study
COMPLETED
|
37
|
28
|
27
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
2
|
Reasons for withdrawal
| Measure |
Healthy Control
Baseline evaluation only
|
ADHD - Placebo
ADHD participants randomized to receive placebo for 12 weeks of treatment
|
ADHD - Vyvanse
ADHD participants randomized to receive 12 weeks of medication treatment with Vyvanse
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
2
|
|
Overall Study
Physician Decision
|
3
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Analysis population includes participants who completed the study.
Baseline characteristics by cohort
| Measure |
Healthy Control
n=37 Participants
Baseline evaluation only
|
ADHD - Placebo
n=28 Participants
ADHD participants randomized to receive placebo for 12 weeks of treatment
|
ADHD - Vyvanse
n=27 Participants
ADHD participants randomized to receive 12 weeks of medication treatment with Vyvanse
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
16.54 years
STANDARD_DEVIATION 6.03 • n=113 Participants • Analysis population includes participants who completed the study.
|
11.93 years
STANDARD_DEVIATION 5.72 • n=163 Participants • Analysis population includes participants who completed the study.
|
12.85 years
STANDARD_DEVIATION 5.68 • n=160 Participants • Analysis population includes participants who completed the study.
|
14.16 years
STANDARD_DEVIATION 6.15 • n=483 Participants • Analysis population includes participants who completed the study.
|
|
Sex: Female, Male
Female
|
15 Participants
n=113 Participants
|
9 Participants
n=163 Participants
|
9 Participants
n=160 Participants
|
33 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=113 Participants
|
19 Participants
n=163 Participants
|
18 Participants
n=160 Participants
|
59 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
21 Participants
n=113 Participants
|
6 Participants
n=163 Participants
|
9 Participants
n=160 Participants
|
36 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
|
6 Participants
n=113 Participants
|
11 Participants
n=163 Participants
|
4 Participants
n=160 Participants
|
21 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
7 Participants
n=113 Participants
|
7 Participants
n=163 Participants
|
10 Participants
n=160 Participants
|
24 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian or Pacific Islander
|
1 Participants
n=113 Participants
|
3 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
6 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian/Alaska Native
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other or Unknown
|
2 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
5 Participants
n=483 Participants
|
|
Brain Structure Volume
Left Hippocampal Volume
|
4182.87 mm^3
STANDARD_DEVIATION 418.83 • n=113 Participants • Analysis population includes participants who completed the study.
|
3933.96 mm^3
STANDARD_DEVIATION 433.45 • n=163 Participants • Analysis population includes participants who completed the study.
|
4121.96 mm^3
STANDARD_DEVIATION 392.76 • n=160 Participants • Analysis population includes participants who completed the study.
|
4090.25 mm^3
STANDARD_DEVIATION 424.92 • n=483 Participants • Analysis population includes participants who completed the study.
|
|
Brain Structure Volume
Left Amygdala Volume
|
1504.81 mm^3
STANDARD_DEVIATION 217.54 • n=113 Participants • Analysis population includes participants who completed the study.
|
1423.08 mm^3
STANDARD_DEVIATION 199.23 • n=163 Participants • Analysis population includes participants who completed the study.
|
1489.02 mm^3
STANDARD_DEVIATION 235.93 • n=160 Participants • Analysis population includes participants who completed the study.
|
1475.62 mm^3
STANDARD_DEVIATION 218.31 • n=483 Participants • Analysis population includes participants who completed the study.
|
|
Brain Structure Volume
Right Hippocampal Volume
|
4288.01 mm^3
STANDARD_DEVIATION 358.26 • n=113 Participants • Analysis population includes participants who completed the study.
|
4011.48 mm^3
STANDARD_DEVIATION 413.65 • n=163 Participants • Analysis population includes participants who completed the study.
|
4185.40 mm^3
STANDARD_DEVIATION 379.97 • n=160 Participants • Analysis population includes participants who completed the study.
|
4174.96 mm^3
STANDARD_DEVIATION 395.07 • n=483 Participants • Analysis population includes participants who completed the study.
|
|
Brain Structure Volume
Right Amygdala Volume
|
1695.09 mm^3
STANDARD_DEVIATION 187.81 • n=113 Participants • Analysis population includes participants who completed the study.
|
1577.34 mm^3
STANDARD_DEVIATION 204.15 • n=163 Participants • Analysis population includes participants who completed the study.
|
1665.87 mm^3
STANDARD_DEVIATION 234.17 • n=160 Participants • Analysis population includes participants who completed the study.
|
1651.16 mm^3
STANDARD_DEVIATION 210.79 • n=483 Participants • Analysis population includes participants who completed the study.
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: ADHD participants who completed 12 weeks of treatment.
Brain structure volume measured in mm\^3
Outcome measures
| Measure |
ADHD - Placebo
n=27 Participants
ADHD participants randomized to receive placebo for 12 weeks of treatment
|
ADHD - Vyvanse
n=28 Participants
ADHD participants randomized to receive 12 weeks of medication treatment with Vyvanse
|
|---|---|---|
|
Brain Structure Volume
Left Hippocampal Volume
|
3909.85 mm^3
Standard Deviation 535.35
|
4069.72 mm^3
Standard Deviation 426.46
|
|
Brain Structure Volume
Left Amygdala Volume
|
1431.31 mm^3
Standard Deviation 245.40
|
1485.05 mm^3
Standard Deviation 235.17
|
|
Brain Structure Volume
Right Hippocampal Volume
|
4048.10 mm^3
Standard Deviation 454.37
|
4206.41 mm^3
Standard Deviation 413.38
|
|
Brain Structure Volume
Right Amygdala Volume
|
1573.57 mm^3
Standard Deviation 240.03
|
1641.88 mm^3
Standard Deviation 207.45
|
Adverse Events
Healthy Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ADHD - Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ADHD - Vyvanse
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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