Trial Outcomes & Findings for Imaging Stimulant and Non Stimulant Treatments for ADHD: A Network Based Approach (NCT NCT01678209)
NCT ID: NCT01678209
Last Updated: 2020-07-24
Results Overview
Comparison of Go-Nogo at 6 weeks from baseline. Performance on a go-nogo task inside the scanner (fMRI). In the go/no-go task, participants respond to certain stimuli ("go" stimuli) and make no response for others ("no-go" stimuli).
COMPLETED
PHASE4
127 participants
Baseline and at 6 weeks
2020-07-24
Participant Flow
Recruitment: 8/10/2012 - 4/30/17; Roll Over Year: 5/1/17 - 4/30/18; Youth with ADHD and Healthy Controls recruited from the community and clinics at Mount Sinai.
Participant milestones
| Measure |
Control Group fMRI Scans Only
Healthy Control Group: will receive initial evaluation, and 2 fMRI (functional magnetic resonance imaging) scans each 6-8 weeks apart
|
Atomoxetine Arm
These subjects will receive initial evaluation and baseline fMRI scan, flexible dose titration with atomoxetine for 6-8 weeks, and fMRI postscan, with optional post study stabilization visits.
|
Methylphenidate Arm
Subjects will receive initial evaluation, baseline fMRI scan, flexible dose titration with methylphenidate (Concerta) for 6-8 weeks, and fMRI scan post treatment.
|
|---|---|---|---|
|
Overall Study
STARTED
|
47
|
40
|
40
|
|
Overall Study
COMPLETED
|
30
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
17
|
18
|
18
|
Reasons for withdrawal
| Measure |
Control Group fMRI Scans Only
Healthy Control Group: will receive initial evaluation, and 2 fMRI (functional magnetic resonance imaging) scans each 6-8 weeks apart
|
Atomoxetine Arm
These subjects will receive initial evaluation and baseline fMRI scan, flexible dose titration with atomoxetine for 6-8 weeks, and fMRI postscan, with optional post study stabilization visits.
|
Methylphenidate Arm
Subjects will receive initial evaluation, baseline fMRI scan, flexible dose titration with methylphenidate (Concerta) for 6-8 weeks, and fMRI scan post treatment.
|
|---|---|---|---|
|
Overall Study
could not scan twice
|
1
|
1
|
1
|
|
Overall Study
scheduling conflicts
|
0
|
0
|
1
|
|
Overall Study
screen fail
|
16
|
17
|
16
|
Baseline Characteristics
Imaging Stimulant and Non Stimulant Treatments for ADHD: A Network Based Approach
Baseline characteristics by cohort
| Measure |
Control Group fMRI Scans Only
n=47 Participants
Healthy Control Group: will receive initial evaluation, and 2 fMRI (functional magnetic resonance imaging) scans each 6-8 weeks apart
|
Atomoxetine Arm
n=22 Participants
These subjects will receive initial evaluation and baseline fMRI scan, flexible dose titration with atomoxetine for 6-8 weeks, and fMRI postscan, with optional post study stabilization visits.
|
Methylphenidate Arm
n=22 Participants
Subjects will receive initial evaluation, baseline fMRI scan, flexible dose titration with methylphenidate (Concerta) for 6-8 weeks, and fMRI scan post treatment.
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
13 years
STANDARD_DEVIATION 2.8 • n=93 Participants
|
10 years
STANDARD_DEVIATION 3.02 • n=4 Participants
|
12 years
STANDARD_DEVIATION 2.86 • n=27 Participants
|
11 years
STANDARD_DEVIATION 3 • n=483 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
27 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
64 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
51 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
16 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
42 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline and at 6 weeksPopulation: All participants in control group including the one subject who could not be scanned twice included in data analysis for the 6 weeks visit. Thirty-one (N=31) controls were scanned twice for this project, but the second scan data for 1 subject was excluded from the analysis for motion. Thus, 31 control subjects were included in the analyses of
Comparison of Go-Nogo at 6 weeks from baseline. Performance on a go-nogo task inside the scanner (fMRI). In the go/no-go task, participants respond to certain stimuli ("go" stimuli) and make no response for others ("no-go" stimuli).
Outcome measures
| Measure |
Control Group fMRI Scans Only
n=47 Participants
Healthy Control Group: will receive initial evaluation, and 2 fMRI (functional magnetic resonance imaging) scans each 6-8 weeks apart
|
Atomoxetine Arm
n=40 Participants
These subjects will receive initial evaluation and baseline fMRI scan, flexible dose titration with atomoxetine for 6-8 weeks, and fMRI postscan, with optional post study stabilization visits.
|
Methylphenidate Arm
n=40 Participants
Subjects will receive initial evaluation, baseline fMRI scan, flexible dose titration with methylphenidate (Concerta) for 6-8 weeks, and fMRI scan post treatment.
|
|---|---|---|---|
|
Percentage of Correct Inhibition in Participants Assessed With the Go-No go Task
Baseline
|
79.08 percent correct inhibition
Standard Deviation 15.07
|
79.43 percent correct inhibition
Standard Deviation 17.27
|
77.98 percent correct inhibition
Standard Deviation 15.10
|
|
Percentage of Correct Inhibition in Participants Assessed With the Go-No go Task
6 weeks
|
78.24 percent correct inhibition
Standard Deviation 16.57
|
80.72 percent correct inhibition
Standard Deviation 14.22
|
81.81 percent correct inhibition
Standard Deviation 14.14
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: All participants in control group including the one subject who could not be scanned twice included in data analysis.
ADHD-RS is an 18-item list of core ADHD symptoms, each item are scored on a 4-point scale from 0-3, with total 0-54, with higher score indicating more symptoms.
Outcome measures
| Measure |
Control Group fMRI Scans Only
n=31 Participants
Healthy Control Group: will receive initial evaluation, and 2 fMRI (functional magnetic resonance imaging) scans each 6-8 weeks apart
|
Atomoxetine Arm
n=22 Participants
These subjects will receive initial evaluation and baseline fMRI scan, flexible dose titration with atomoxetine for 6-8 weeks, and fMRI postscan, with optional post study stabilization visits.
|
Methylphenidate Arm
n=22 Participants
Subjects will receive initial evaluation, baseline fMRI scan, flexible dose titration with methylphenidate (Concerta) for 6-8 weeks, and fMRI scan post treatment.
|
|---|---|---|---|
|
Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale (ADHD-RS)
|
1 score on a scale
Standard Deviation 2
|
15 score on a scale
Standard Deviation 11
|
18 score on a scale
Standard Deviation 12
|
SECONDARY outcome
Timeframe: up to 6 weeksPopulation: All participants in control group including the one subject who could not be scanned twice included in data analysis.
a clinician rated measure of symptom severity. CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Outcome measures
| Measure |
Control Group fMRI Scans Only
n=31 Participants
Healthy Control Group: will receive initial evaluation, and 2 fMRI (functional magnetic resonance imaging) scans each 6-8 weeks apart
|
Atomoxetine Arm
n=22 Participants
These subjects will receive initial evaluation and baseline fMRI scan, flexible dose titration with atomoxetine for 6-8 weeks, and fMRI postscan, with optional post study stabilization visits.
|
Methylphenidate Arm
n=22 Participants
Subjects will receive initial evaluation, baseline fMRI scan, flexible dose titration with methylphenidate (Concerta) for 6-8 weeks, and fMRI scan post treatment.
|
|---|---|---|---|
|
Clinical Global Impressions-Severity (CGI-S)
|
1 score on a scale
Standard Deviation 0
|
3.2 score on a scale
Standard Deviation 1.6
|
3.4 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: baseline and at 6 weeksPopulation: All participants in control group including the one subject who could not be scanned twice included in data analysis for the 6 weeks visit.
A neuropsychological assessment of attention compared at 6 weeks from baseline by looking at response time. The ANT is a task designed to test three attentional networks in children and adults: alerting, orienting, and executive control. The response time were summed.
Outcome measures
| Measure |
Control Group fMRI Scans Only
n=47 Participants
Healthy Control Group: will receive initial evaluation, and 2 fMRI (functional magnetic resonance imaging) scans each 6-8 weeks apart
|
Atomoxetine Arm
n=40 Participants
These subjects will receive initial evaluation and baseline fMRI scan, flexible dose titration with atomoxetine for 6-8 weeks, and fMRI postscan, with optional post study stabilization visits.
|
Methylphenidate Arm
n=40 Participants
Subjects will receive initial evaluation, baseline fMRI scan, flexible dose titration with methylphenidate (Concerta) for 6-8 weeks, and fMRI scan post treatment.
|
|---|---|---|---|
|
Response Time in Attention Networks Test (ANT)
Baseline
|
817.50 milliseconds
Standard Deviation 171.06
|
856.60 milliseconds
Standard Deviation 179.34
|
885.68 milliseconds
Standard Deviation 170.76
|
|
Response Time in Attention Networks Test (ANT)
6 weeks
|
756.87 milliseconds
Standard Deviation 153.83
|
826.14 milliseconds
Standard Deviation 139.08
|
783.09 milliseconds
Standard Deviation 125.21
|
SECONDARY outcome
Timeframe: baseline and at 6 weeksPopulation: All participants in control group including the one subject who could not be scanned twice included in data analysis for the 6 weeks visit.
A neuropsychological assessment of attention compared at 6 weeks from baseline. CPT is a task-oriented computerized assessment of attention-related problems.This score indicates the number of times the client responded but no target was presented. A fast reaction time and high commission error rate points to difficulties with impulsivity. A slow reaction time with high commission and omission errors, indicates inattention in general. Scores are compared with the normative scores for the age, group and gender of the person being tested and represented as a commissioned T-score. The T-score indicates the degree to which performance in CPT task is higher or lower than the performance of a healthy individual matched in age. A T-score of 50 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of more attention-related problems.
Outcome measures
| Measure |
Control Group fMRI Scans Only
n=47 Participants
Healthy Control Group: will receive initial evaluation, and 2 fMRI (functional magnetic resonance imaging) scans each 6-8 weeks apart
|
Atomoxetine Arm
n=40 Participants
These subjects will receive initial evaluation and baseline fMRI scan, flexible dose titration with atomoxetine for 6-8 weeks, and fMRI postscan, with optional post study stabilization visits.
|
Methylphenidate Arm
n=40 Participants
Subjects will receive initial evaluation, baseline fMRI scan, flexible dose titration with methylphenidate (Concerta) for 6-8 weeks, and fMRI scan post treatment.
|
|---|---|---|---|
|
Continuous Performance Test (CPT)
Baseline
|
46.65 commissioned t-score
Standard Deviation 11.29
|
55.26 commissioned t-score
Standard Deviation 5.62
|
52.94 commissioned t-score
Standard Deviation 9.19
|
|
Continuous Performance Test (CPT)
6 weeks
|
44.64 commissioned t-score
Standard Deviation 9.70
|
50.70 commissioned t-score
Standard Deviation 8.66
|
48.46 commissioned t-score
Standard Deviation 10.43
|
SECONDARY outcome
Timeframe: baseline and at 6 weeksPopulation: All participants in control group including the one subject who could not be scanned twice included in data analysis for the 6 weeks visit.
A cognitive/neuropsychological measure of auditory/verbal working memory compared at 6 weeks from baseline. Digit Span. Memory span is the longest list of items that a person can repeat back in correct order immediately after presentation on 50% of all trials. Items may include words, numbers, or letters. The task is known as digit span when numbers are used. Memory span is a common measure of short-term memory. A digit-span task is used to measure working memory's number storage capacity.The item score is the sum of the scores on the two trials for that item (range=0-2). The total raw score for backwards digit span is the sum of the item scores; maximum backwards digit span total raw score is 0-16 points. Higher score indicates better health outcomes.
Outcome measures
| Measure |
Control Group fMRI Scans Only
n=47 Participants
Healthy Control Group: will receive initial evaluation, and 2 fMRI (functional magnetic resonance imaging) scans each 6-8 weeks apart
|
Atomoxetine Arm
n=40 Participants
These subjects will receive initial evaluation and baseline fMRI scan, flexible dose titration with atomoxetine for 6-8 weeks, and fMRI postscan, with optional post study stabilization visits.
|
Methylphenidate Arm
n=40 Participants
Subjects will receive initial evaluation, baseline fMRI scan, flexible dose titration with methylphenidate (Concerta) for 6-8 weeks, and fMRI scan post treatment.
|
|---|---|---|---|
|
Digit Span
Baseline
|
13.30 score on a scale
Standard Deviation 18.76
|
9.25 score on a scale
Standard Deviation 2.06
|
7.5 score on a scale
Standard Deviation 1.29
|
|
Digit Span
6 weeks
|
9.39 score on a scale
Standard Deviation 1.58
|
9.75 score on a scale
Standard Deviation 0.95
|
8.5 score on a scale
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: baseline and at 6 weeksPopulation: All participants in control group including the one subject who could not be scanned twice included in data analysis for the 6 weeks visit.
A neuropsychological measure of motor skill and visual-spatial working memory compared at 6 weeks from baseline. The Finger Windows subtest is a measure of nonverbal, rote sequential recall. scaled scores ranging from 1 to 19, with higher score indicating better attention or concentration.
Outcome measures
| Measure |
Control Group fMRI Scans Only
n=47 Participants
Healthy Control Group: will receive initial evaluation, and 2 fMRI (functional magnetic resonance imaging) scans each 6-8 weeks apart
|
Atomoxetine Arm
n=40 Participants
These subjects will receive initial evaluation and baseline fMRI scan, flexible dose titration with atomoxetine for 6-8 weeks, and fMRI postscan, with optional post study stabilization visits.
|
Methylphenidate Arm
n=40 Participants
Subjects will receive initial evaluation, baseline fMRI scan, flexible dose titration with methylphenidate (Concerta) for 6-8 weeks, and fMRI scan post treatment.
|
|---|---|---|---|
|
Finger Windows
Baseline
|
17.04 score on a scale
Standard Deviation 3.69
|
14.50 score on a scale
Standard Deviation 2.64
|
16.50 score on a scale
Standard Deviation 5.19
|
|
Finger Windows
6 weeks
|
17.65 score on a scale
Standard Deviation 5.33
|
16.25 score on a scale
Standard Deviation 6.65
|
16.25 score on a scale
Standard Deviation 6.39
|
Adverse Events
fMRI Scans
Atomoxetine Arm
Methylphenidate Arm
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
fMRI Scans
n=47 participants at risk
Healthy Control Group: will receive initial evaluation, and 2 fMRI (functional magnetic resonance imaging) scans each 6-8 weeks apart
|
Atomoxetine Arm
n=22 participants at risk
These subjects will receive initial evaluation and baseline fMRI scan, flexible dose titration with atomoxetine for 6-8 weeks, and fMRI postscan, with optional post study stabilization visits.
|
Methylphenidate Arm
n=22 participants at risk
Subjects will receive initial evaluation, baseline fMRI scan, flexible dose titration with methylphenidate (Concerta) for 6-8 weeks, and fMRI scan post treatment.
|
|---|---|---|---|
|
Gastrointestinal disorders
Decreased appetite
|
0.00%
0/47 • 8 weeks
|
9.1%
2/22 • 8 weeks
|
18.2%
4/22 • 8 weeks
|
|
Gastrointestinal disorders
Stomachache
|
0.00%
0/47 • 8 weeks
|
13.6%
3/22 • 8 weeks
|
4.5%
1/22 • 8 weeks
|
|
General disorders
Headache
|
0.00%
0/47 • 8 weeks
|
9.1%
2/22 • 8 weeks
|
4.5%
1/22 • 8 weeks
|
|
Psychiatric disorders
Moody/irritable
|
2.1%
1/47 • 8 weeks
|
13.6%
3/22 • 8 weeks
|
13.6%
3/22 • 8 weeks
|
|
General disorders
Common cold/allergies
|
2.1%
1/47 • 8 weeks
|
4.5%
1/22 • 8 weeks
|
18.2%
4/22 • 8 weeks
|
|
Psychiatric disorders
Anxious
|
0.00%
0/47 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
4.5%
1/22 • 8 weeks
|
|
General disorders
Sleep problems
|
4.3%
2/47 • 8 weeks
|
18.2%
4/22 • 8 weeks
|
4.5%
1/22 • 8 weeks
|
|
General disorders
Lightheaded/dizzy
|
0.00%
0/47 • 8 weeks
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/47 • 8 weeks
|
9.1%
2/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
|
Vascular disorders
Increased blood pressure
|
0.00%
0/47 • 8 weeks
|
4.5%
1/22 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
Additional Information
Beth Krone, PhD
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee Dr. Newcorn has FCOI reporting obligations as stipulated by the Mount Sinai FCOI committee
- Publication restrictions are in place
Restriction type: OTHER