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Diagnostic Utility of Attention Deficit Hyperactivity Disorder (ADHD) by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials

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ClinicalTrials.gov Identifier: NCT01063153
Recruitment Status : Completed
First Posted : February 5, 2010
Results First Posted : December 9, 2013
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
ElMindA Ltd
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Attention Deficit Hyperactivity Disorder
Intervention Drug: Osmotic Release Methylphenidate
Enrollment 71
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control ADHD
Hide Arm/Group Description Controls without ADHD were assessed using EEG Subjects with ADHD were assessed with EEG before and after treatment with Concerta
Period Title: Overall Study
Started 33 38
Completed 31 26
Not Completed 2 12
Reason Not Completed
Found Ineligible During Screening             2             0
Lost to Follow-up             0             7
Withdrawal by Subject             0             1
Physician Decision             0             4
Arm/Group Title Control ADHD Total
Hide Arm/Group Description Subjects without ADHD Subjects with ADHD Total of all reporting groups
Overall Number of Baseline Participants 33 38 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 38 participants 71 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
33
 100.0%
38
 100.0%
71
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 38 participants 71 participants
32.2  (11.0) 35.5  (10.5) 34.0  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 38 participants 71 participants
Female
16
  48.5%
14
  36.8%
30
  42.3%
Male
17
  51.5%
24
  63.2%
41
  57.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 38 participants 71 participants
33 38 71
1.Primary Outcome
Title Adult ADHD Investigator Symptom Rating Scale (AISRS)
Hide Description 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.
Time Frame Baseline and 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ADHD Controls
Hide Arm/Group Description:
Subjects with ADHD were assessed before and after treatment.
Controls without ADHD were assessed with a one-time EEG, only.
Overall Number of Participants Analyzed 28 0
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 37.0  (8.7)
6 weeks 15.0  (9.4)
2.Primary Outcome
Title Percent Errors in Visual Go/NoGo Task
Hide Description 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.
Time Frame Single Point (Baseline)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only subjects that met the a priori pre-defined EEG signal quality criteria were included.
Arm/Group Title ADHD and Visual NoGo Task Control Group and Visual NoGo Task ADHD and Visual Go Task Control Group and Visual Go Task
Hide Arm/Group Description:
Participants with a DSM-IV diagnosis of ADHD completed the NoGo Visual Task, in which they had to refrain from responding.
Participants without a DSM-IV diagnosis of ADHD completed the NoGo Visual Task, in which they had to refrain from responding.
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.
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.
Overall Number of Participants Analyzed 26 27 30 26
Measure Type: Number
Unit of Measure: percentage of errors
19.01 13.89 2.88 1.27
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control ADHD
Hide Arm/Group Description Subjects without ADHD were assessed using EEG. Subjects with ADHD were assessed with EEG before and after open-label treatment with Concerta.
All-Cause Mortality
Control ADHD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control ADHD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/33 (0.00%)      0/38 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Control ADHD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/33 (0.00%)      22/38 (57.89%)    
Cardiac disorders     
Racing Heart *  0/33 (0.00%)  0 3/38 (7.89%)  5
Gastrointestinal disorders     
Gastrointestinal Upset *  0/33 (0.00%)  0 3/38 (7.89%)  3
General disorders     
Dry Mouth *  0/33 (0.00%)  0 2/38 (5.26%)  5
Headache *  0/33 (0.00%)  0 11/38 (28.95%)  19
Increased Energy *  0/33 (0.00%)  0 3/38 (7.89%)  5
Irritability *  0/33 (0.00%)  0 3/38 (7.89%)  7
Jitteriness *  0/33 (0.00%)  0 4/38 (10.53%)  7
Tiredness *  0/33 (0.00%)  0 4/38 (10.53%)  8
Metabolism and nutrition disorders     
Decreased Appetite *  0/33 (0.00%)  0 9/38 (23.68%)  20
Musculoskeletal and connective tissue disorders     
Tension *  0/33 (0.00%)  0 6/38 (15.79%)  10
Psychiatric disorders     
Anxiety *  0/33 (0.00%)  0 3/38 (7.89%)  3
Dulled Affect *  0/33 (0.00%)  0 4/38 (10.53%)  5
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD
Organization: Massachusetts General Hospital
Phone: (617)-724-0006
Responsible Party: Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01063153     History of Changes
Other Study ID Numbers: 2009-P-000174
First Submitted: February 3, 2010
First Posted: February 5, 2010
Results First Submitted: June 12, 2013
Results First Posted: December 9, 2013
Last Update Posted: May 3, 2017