Trial Outcomes & Findings for Diagnostic Utility of Attention Deficit Hyperactivity Disorder (ADHD) by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials (NCT NCT01063153)
NCT ID: NCT01063153
Last Updated: 2017-05-03
Results Overview
An 18-item scale rating a subject's level of impairment from 0 (none) to 3 (severe) for each symptom of DSM-IV ADHD, with a maximum possible score of 54. The measure was collected at Baseline and 6 weeks, and a total score was calculated to gauge treatment response of ADHD subjects to open-label Concerta.
COMPLETED
PHASE4
71 participants
Baseline and 6 weeks
2017-05-03
Participant Flow
Participant milestones
| Measure |
Control
Controls without ADHD were assessed using EEG
|
ADHD
Subjects with ADHD were assessed with EEG before and after treatment with Concerta
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
38
|
|
Overall Study
COMPLETED
|
31
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
12
|
Reasons for withdrawal
| Measure |
Control
Controls without ADHD were assessed using EEG
|
ADHD
Subjects with ADHD were assessed with EEG before and after treatment with Concerta
|
|---|---|---|
|
Overall Study
Found Ineligible During Screening
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
7
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
4
|
Baseline Characteristics
Diagnostic Utility of Attention Deficit Hyperactivity Disorder (ADHD) by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials
Baseline characteristics by cohort
| Measure |
Control
n=33 Participants
Subjects without ADHD
|
ADHD
n=38 Participants
Subjects with ADHD
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
32.2 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
35.5 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
34.0 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
38 participants
n=7 Participants
|
71 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksPopulation: Subjects in the ADHD group who completed all 6 weeks of the trial were included in data analysis. Subjects who completed at least 3 weeks of treatment were also included regardless of the reason for withdrawal, and final-visit AISRS scores were used in ITT (intent-to-treat) analysis via last observation carried forward \[LOCF\] imputation.
An 18-item scale rating a subject's level of impairment from 0 (none) to 3 (severe) for each symptom of DSM-IV ADHD, with a maximum possible score of 54. The measure was collected at Baseline and 6 weeks, and a total score was calculated to gauge treatment response of ADHD subjects to open-label Concerta.
Outcome measures
| Measure |
ADHD
n=28 Participants
Subjects with ADHD were assessed before and after treatment.
|
Controls
Controls without ADHD were assessed with a one-time EEG, only.
|
ADHD and Visual Go Task
Participants with a DSM-IV diagnosis of ADHD completed the Go Visual Task, in which they had to perform a motor response to a stimulus.
|
Control Group and Visual Go Task
Participants without a DSM-IV diagnosis of ADHD completed the Go Visual Task, in which they had to perform a motor response to a stimulus.
|
|---|---|---|---|---|
|
Adult ADHD Investigator Symptom Rating Scale (AISRS)
6 weeks
|
15.0 units on a scale
Standard Deviation 9.4
|
—
|
—
|
—
|
|
Adult ADHD Investigator Symptom Rating Scale (AISRS)
Baseline
|
37.0 units on a scale
Standard Deviation 8.7
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Single Point (Baseline)Population: Only subjects that met the a priori pre-defined EEG signal quality criteria were included.
The Go/NoGo visual task was completed by subjects with ADHD as well as healthy controls. The Go/NoGo task is used to assess inhibitory control, and targets response inhibition, executive functions, and sustained attention. The 'Go' stimulus occupies 80% of the trials, and requires the subject to perform a motor response each time it appears on the screen. A rare 'No Go' stimulus (occupies 20% of all trials) requires the subject to refrain from responding. The percentage of errors were measured for each group.
Outcome measures
| Measure |
ADHD
n=26 Participants
Subjects with ADHD were assessed before and after treatment.
|
Controls
n=27 Participants
Controls without ADHD were assessed with a one-time EEG, only.
|
ADHD and Visual Go Task
n=30 Participants
Participants with a DSM-IV diagnosis of ADHD completed the Go Visual Task, in which they had to perform a motor response to a stimulus.
|
Control Group and Visual Go Task
n=26 Participants
Participants without a DSM-IV diagnosis of ADHD completed the Go Visual Task, in which they had to perform a motor response to a stimulus.
|
|---|---|---|---|---|
|
Percent Errors in Visual Go/NoGo Task
|
19.01 percentage of errors
|
13.89 percentage of errors
|
2.88 percentage of errors
|
1.27 percentage of errors
|
Adverse Events
Control
ADHD
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=33 participants at risk
Subjects without ADHD were assessed using EEG.
|
ADHD
n=38 participants at risk
Subjects with ADHD were assessed with EEG before and after open-label treatment with Concerta.
|
|---|---|---|
|
Psychiatric disorders
Anxiety
|
0.00%
0/33
|
7.9%
3/38 • Number of events 3
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/33
|
23.7%
9/38 • Number of events 20
|
|
General disorders
Dry Mouth
|
0.00%
0/33
|
5.3%
2/38 • Number of events 5
|
|
Psychiatric disorders
Dulled Affect
|
0.00%
0/33
|
10.5%
4/38 • Number of events 5
|
|
Gastrointestinal disorders
Gastrointestinal Upset
|
0.00%
0/33
|
7.9%
3/38 • Number of events 3
|
|
General disorders
Headache
|
0.00%
0/33
|
28.9%
11/38 • Number of events 19
|
|
Cardiac disorders
Racing Heart
|
0.00%
0/33
|
7.9%
3/38 • Number of events 5
|
|
General disorders
Increased Energy
|
0.00%
0/33
|
7.9%
3/38 • Number of events 5
|
|
General disorders
Irritability
|
0.00%
0/33
|
7.9%
3/38 • Number of events 7
|
|
General disorders
Jitteriness
|
0.00%
0/33
|
10.5%
4/38 • Number of events 7
|
|
General disorders
Tiredness
|
0.00%
0/33
|
10.5%
4/38 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Tension
|
0.00%
0/33
|
15.8%
6/38 • Number of events 10
|
Additional Information
Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD
Massachusetts General Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee Brain Network Analysis \[the primary analysis of EEG data related to BAFPA (Brain Activity Flow Patterns Analysis) and functional connectivity networks\] is still in progress by the Sponsor, and there is an agreement between the Sponsor and the Principal Investigator preventing the PI from disclosing EEG results from this trial until the data has been published. We are, however, at liberty to report adverse events from the open-label clinical trial and have done so here.
- Publication restrictions are in place
Restriction type: OTHER