Trial Outcomes & Findings for Neurobiological Basis of Response to Vyvanse in Adults With ADHD: an fMRI Study of Brain Activation (NCT NCT01924429)
NCT ID: NCT01924429
Last Updated: 2018-06-06
Results Overview
Performance Measures on the Go/No-Go Task assessed by fMRI as a Function of Trial Type, Face Emotion, and Drug Condition in Adults with Attention-Deficit/Hyperactivity Disorder. The Go/No-Go Task is a neuropsychological test that provides a direct measure of number of responses made that are "correct" or "incorrect". It is not a scale. Reported are the percentage of correct responses on that direct performance measure. 0% correct is worse than 100% correct.
COMPLETED
PHASE4
30 participants
8 weeks
2018-06-06
Participant Flow
Participant milestones
| Measure |
On Drug Then Off Drug
Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg
Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg
|
Off Drug Then on Drug
Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg
Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg
|
|---|---|---|
|
Period 1 - First Intervention (4 Weeks)
STARTED
|
17
|
13
|
|
Period 1 - First Intervention (4 Weeks)
COMPLETED
|
17
|
13
|
|
Period 1 - First Intervention (4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (2 Weeks)
STARTED
|
17
|
13
|
|
Washout Period (2 Weeks)
COMPLETED
|
14
|
11
|
|
Washout Period (2 Weeks)
NOT COMPLETED
|
3
|
2
|
|
Period 2 - Second Intervention (4 Weeks)
STARTED
|
14
|
11
|
|
Period 2 - Second Intervention (4 Weeks)
COMPLETED
|
14
|
11
|
|
Period 2 - Second Intervention (4 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
On Drug Then Off Drug
Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg
Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg
|
Off Drug Then on Drug
Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg
Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg
|
|---|---|---|
|
Washout Period (2 Weeks)
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Neurobiological Basis of Response to Vyvanse in Adults With ADHD: an fMRI Study of Brain Activation
Baseline characteristics by cohort
| Measure |
On Drug, Then Off Drug
n=17 Participants
fMRI #1 on drug, #2 off drug
|
Off Drug, Then on Drug
n=13 Participants
fMRI #1 off drug, #2 on drug
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.46 years
STANDARD_DEVIATION 11.82 • n=5 Participants
|
37.27 years
STANDARD_DEVIATION 11.81 • n=7 Participants
|
35.84 years
STANDARD_DEVIATION 10.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Performance measures are done while participants are off drug and while on drug.
Performance Measures on the Go/No-Go Task assessed by fMRI as a Function of Trial Type, Face Emotion, and Drug Condition in Adults with Attention-Deficit/Hyperactivity Disorder. The Go/No-Go Task is a neuropsychological test that provides a direct measure of number of responses made that are "correct" or "incorrect". It is not a scale. Reported are the percentage of correct responses on that direct performance measure. 0% correct is worse than 100% correct.
Outcome measures
| Measure |
Placebo
n=25 Participants
Participants received fMRI while off drug
|
Lisdexamfetamine
n=25 Participants
Participants received fMRI while on drug
|
|---|---|---|
|
The Go/No-Go Task Percentage Assessed by fMRI
Happy Correct Responses
|
91.7 percentage correct responses/inhibitions
Standard Error 2.8
|
97.0 percentage correct responses/inhibitions
Standard Error 3.8
|
|
The Go/No-Go Task Percentage Assessed by fMRI
Happy Correct Inhibitions
|
88.7 percentage correct responses/inhibitions
Standard Error 9.4
|
87.9 percentage correct responses/inhibitions
Standard Error 11.5
|
|
The Go/No-Go Task Percentage Assessed by fMRI
Sad Correct Responses
|
90.3 percentage correct responses/inhibitions
Standard Error 7.7
|
88.5 percentage correct responses/inhibitions
Standard Error 10.6
|
|
The Go/No-Go Task Percentage Assessed by fMRI
Sad Correct Inhibitions
|
84.4 percentage correct responses/inhibitions
Standard Error 12.5
|
86.7 percentage correct responses/inhibitions
Standard Error 11.3
|
|
The Go/No-Go Task Percentage Assessed by fMRI
Neutral Correct Responses
|
93.2 percentage correct responses/inhibitions
Standard Error 12.2
|
95.6 percentage correct responses/inhibitions
Standard Error 5.8
|
|
The Go/No-Go Task Percentage Assessed by fMRI
Neutral Correct Inhibitions
|
77.5 percentage correct responses/inhibitions
Standard Error 12.3
|
79.6 percentage correct responses/inhibitions
Standard Error 11.6
|
PRIMARY outcome
Timeframe: up to 6 weeksReaction-time, as measured by the reaction time test Go/No-Go Task as a Function of Trial Type, Face Emotion, and Drug Condition in Adults with Attention-Deficit/Hyperactivity Disorder
Outcome measures
| Measure |
Placebo
n=25 Participants
Participants received fMRI while off drug
|
Lisdexamfetamine
n=25 Participants
Participants received fMRI while on drug
|
|---|---|---|
|
fMRI Reaction Time
Happy
|
532 ms
Standard Error 99
|
519 ms
Standard Error 114
|
|
fMRI Reaction Time
Sad
|
533 ms
Standard Error 110
|
509 ms
Standard Error 96
|
|
fMRI Reaction Time
Neutral
|
553 ms
Standard Error 109
|
533 ms
Standard Error 104
|
SECONDARY outcome
Timeframe: BaselineBehavior Rating Inventory of Executive Function®-Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (0 to 100, with 50 +/-1 SD = 'Normal', higher is worse, more impaired)
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received fMRI while off drug
|
Lisdexamfetamine
n=11 Participants
Participants received fMRI while on drug
|
|---|---|---|
|
BRIEF-A
|
66.64 t-score
Standard Deviation 11.89
|
73.5 t-score
Standard Deviation 14.75
|
SECONDARY outcome
Timeframe: at one weekPopulation: not collected
Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (higher is worse)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at 4 weeksPopulation: not collected
Behavior Rating Inventory of Executive Function®-Adult Version (BRIEF-A): Norm Referenced Measure of Impaired Executive Functioning, reported in T-Scores (higher is worse)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineADHD and Related Symptoms Measure (ASRS): self report, reported as Sum of Responses (0-4 per item, higher = more impaired) 0-26 (normal range) and \>27 (clinically significant symptoms).
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received fMRI while off drug
|
Lisdexamfetamine
n=11 Participants
Participants received fMRI while on drug
|
|---|---|---|
|
ASRS - Expanded
|
83.7 units on a scale
Standard Deviation 25.59
|
86 units on a scale
Standard Deviation 4.24
|
SECONDARY outcome
Timeframe: at one weekPopulation: not collected
ADHD and Related Symptoms Measure (ASRS): self report, reported as Sum of Responses (0-4 per item, higher = more impaired) 0-26 (normal range) and \>27 (clinically significant symptoms).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at 4 weeksPopulation: not collected
ADHD and Related Symptoms Measure (ASRS): self report, reported as Sum of Responses (0-4 per item, higher = more impaired) 0-26 (normal range) and \>27 (clinically significant symptoms).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineThe Wender-Reimherr adult attention deficit disorder scale (WRAADS): Symptom measure for emotional functioning/lability, generally reported as Sum of Responses (0-2 per item, higher = more impaired). For this outcome measure, Average scores for particular questions were taken - specifically question 3, question 4, and question 5.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received fMRI while off drug
|
Lisdexamfetamine
n=11 Participants
Participants received fMRI while on drug
|
|---|---|---|
|
WRAADS
Question 3
|
0.80 units on a scale
Standard Deviation 0.86
|
0.94 units on a scale
Standard Deviation 0.745
|
|
WRAADS
Question 4
|
1.27 units on a scale
Standard Deviation 1.22
|
1.47 units on a scale
Standard Deviation 1.23
|
|
WRAADS
Question 5
|
1.13 units on a scale
Standard Deviation 1.35
|
1.82 units on a scale
Standard Deviation 1.19
|
SECONDARY outcome
Timeframe: BaselineADHD symptoms and severity. Norm referenced interview to assess severity and frequency of ADHD symptoms. 18 Items are scored 0-3 to reflect severity and frequency of ADHD symptoms, and a sum is taken. Full range from 0 to 54, with higher number indicating more symptoms and severity.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received fMRI while off drug
|
Lisdexamfetamine
n=11 Participants
Participants received fMRI while on drug
|
|---|---|---|
|
ADHD-RS-IV Combined Sum
On Drug
|
11.00 units on a scale
Standard Deviation 6.98
|
13.67 units on a scale
Standard Deviation 11.64
|
|
ADHD-RS-IV Combined Sum
Placebo
|
25.65 units on a scale
Standard Deviation 8.53
|
31.00 units on a scale
Standard Deviation 14.80
|
SECONDARY outcome
Timeframe: 4 weeks and 8 weeksADHD symptoms and severity - subscale for Inattentiveness. 9-item scale, each scored 0-3, with total from 0 to 27. Higher score indicates higher level of inattentiveness.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received fMRI while off drug
|
Lisdexamfetamine
n=11 Participants
Participants received fMRI while on drug
|
|---|---|---|
|
ADHD-Inattentive
On drug
|
7.36 units on a scale
Standard Deviation 4.53
|
8.83 units on a scale
Standard Deviation 7.63
|
|
ADHD-Inattentive
Placebo
|
18.94 units on a scale
Standard Deviation 6.21
|
19.2 units on a scale
Standard Deviation 5.07
|
SECONDARY outcome
Timeframe: BaselineClinical Global Impressions - CGI-I: Clinical response was the Clinical Global Impression-Improvement scale (CGI-I). Lower CGI-I scores indicate greater improvement (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse).
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received fMRI while off drug
|
Lisdexamfetamine
n=11 Participants
Participants received fMRI while on drug
|
|---|---|---|
|
CGI-I
|
1.88 units on a scale
Standard Deviation 1.13
|
2.00 units on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: baselineCGI-S: Severity of impairment due to ADHD was measured by the Clinical Global Impressions-Severity scale (CGI-S). Lower scores indicate less severe impairment from symptoms, with a CGI-I=1 indicating the person is "normal" with no impairment. (1= normal, not ill, 2= minimally ill, 3= mildly ill, 4= moderately ill, 5=markedly ill, 6=severely ill, 7= very severely ill)
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received fMRI while off drug
|
Lisdexamfetamine
n=11 Participants
Participants received fMRI while on drug
|
|---|---|---|
|
CGI-S
|
4.9 units on a scale
Standard Deviation 1.0
|
4.95 units on a scale
Standard Deviation 0.9
|
Adverse Events
On Drug, Then Off Drug
Off Drug, Then on Drug
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
On Drug, Then Off Drug
n=14 participants at risk
Participants receive fMRI #1 on drug, #2 off drug Escalating stepped titration: 30, 50 or 70mg
Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg
|
Off Drug, Then on Drug
n=11 participants at risk
Participants receive fMRI #1 off drug, #2 on drug Escalating stepped dose titration: 30, 50, 70mg
Lisdexamphetamine: Escalating stepped dose titration: 30, 50 or 70mg
|
|---|---|---|
|
General disorders
Incidental finding on brain scan
|
0.00%
0/14
|
9.1%
1/11
|
|
General disorders
Incidental Physical finding
|
21.4%
3/14
|
0.00%
0/11
|
|
General disorders
Insomnia
|
14.3%
2/14
|
9.1%
1/11
|
|
General disorders
Heart Racing
|
7.1%
1/14
|
0.00%
0/11
|
|
General disorders
Dry mouth
|
7.1%
1/14
|
18.2%
2/11
|
|
General disorders
feeling agitated
|
7.1%
1/14
|
0.00%
0/11
|
|
General disorders
Tired
|
7.1%
1/14
|
0.00%
0/11
|
|
General disorders
Anxious
|
7.1%
1/14
|
18.2%
2/11
|
|
General disorders
Headache
|
7.1%
1/14
|
18.2%
2/11
|
|
General disorders
Restless
|
7.1%
1/14
|
0.00%
0/11
|
|
General disorders
Seasonal allergies
|
0.00%
0/14
|
18.2%
2/11
|
|
General disorders
Subjectively feeling "stuck"
|
0.00%
0/14
|
9.1%
1/11
|
|
General disorders
Suspiciousness
|
7.1%
1/14
|
0.00%
0/11
|
|
Musculoskeletal and connective tissue disorders
Backache
|
7.1%
1/14
|
0.00%
0/11
|
|
General disorders
Reduced Appetite
|
7.1%
1/14
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Skin Sores
|
7.1%
1/14
|
0.00%
0/11
|
|
General disorders
Bruxism
|
0.00%
0/14
|
9.1%
1/11
|
Additional Information
Dr. Jeffrey Newcorn
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place