Back to resultsDiagnostic Utility of Attention Deficit Hyperactivity Disorder (ADHD) by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Osmotic Release Methylphenidate
Sponsored by
About this trial
This is an interventional diagnostic trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Adults, Electroencephalography (EEG), Concerta
Eligibility Criteria
ADHD Subjects
Inclusion Criteria:
- Male and female outpatients, aged 18-55 years
- Subjects meeting full criteria for the diagnosis of DSM-IV (Diagnostic and Statistical Manual, Version 4) Attention Deficit Hyperactivity Disorder (ADHD)
- Absence of pharmacological treatment for ADHD for at least one week.
- Right handedness
Exclusion Criteria:
- Any other current psychiatric or medical condition determined to be clinically significant.
- Current use of psychotropics or any medication with clinically significant CNS (Central Nervous System) effects.
- Mental retardation (IQ < 80).
- Significant sensory deficits such as deafness or blindness.
- Individuals with a history of substance dependence or abuse within the past 6 months.
- Pregnant or nursing females.
- Subjects with pre-existing structural cardiac abnormalities.
- Clinically significant abnormal laboratory values, electrocardiogram or blood pressure reading
Healthy Control Subjects
Inclusion Criteria:
- Males and females, aged 18-55 years
- Subjects who do not meet full criteria for the diagnosis of DSM-IV Attention Deficit Hyperactivity Disorder (ADHD), as determined by clinical evaluation and/or ADHD module of structured diagnostic interview, completed by the study clinician.
- Right handedness
Exclusion Criteria:
- Any current psychiatric or medical condition determined to be clinically significant.
- Current use of psychotropics or any medication with clinically significant CNS effects.
- Mental retardation (IQ < 80).
- Significant sensory deficits such as deafness or blindness.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Concerta
Control group
Arm Description
Open-Label Concerta (Osmotic Release Methylphenidate)
Healthy subjects without ADHD will be assessed using EEG.
Outcomes
Primary Outcome Measures
Adult ADHD Investigator Symptom Rating Scale (AISRS)
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.
Percent Errors in Visual Go/NoGo Task
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01063153
First Posted
February 3, 2010
Last Updated
March 30, 2017
Sponsor
Massachusetts General Hospital
Collaborators
ElMindA Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01063153
Brief Title
Diagnostic Utility of Attention Deficit Hyperactivity Disorder (ADHD) by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials
Official Title
Diagnostic Utility of ADHD by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
ElMindA Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this research study is to study a device called an electroencephalograph (EEG) in the diagnosis of treatment of attention deficit hyperactivity disorder (ADHD) in adults. People with ADHD have symptoms such as difficulty sustaining attention, organizing, and managing impulsivity. They can have trouble in school, at work, and at home. Subjects with ADHD who participate in this study will be given a once daily stimulant medication called osmotic release methylphenidate (Concerta) for 6 weeks, and have EEG testing done before and after the treatment period. Subjects will perform a computer based cognitive task during EEG testing. The U.S. Food and Drug Administration has approved osmotic release methylphenidate (Concerta) for the treatment of ADHD in adults and children. Similar procedures, without medication, will be performed with a sample of healthy adults without ADHD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Adults, Electroencephalography (EEG), Concerta
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Concerta
Arm Type
Experimental
Arm Description
Open-Label Concerta (Osmotic Release Methylphenidate)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Healthy subjects without ADHD will be assessed using EEG.
Intervention Type
Drug
Intervention Name(s)
Osmotic Release Methylphenidate
Other Intervention Name(s)
Concerta
Intervention Description
During a 6 week treatment period, adult subjects with ADHD are prescribed, in an open label fashion, once daily doses of osmotic release methylphenidate to a maximum daily dose of 144 mg. Efficacy and tolerability assessments are completed, in addition to EEG and cognitive testing. Healthy adults without ADHD will not receive medication.
Primary Outcome Measure Information:
Title
Adult ADHD Investigator Symptom Rating Scale (AISRS)
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
Title
Percent Errors in Visual Go/NoGo Task
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
ADHD Subjects
Inclusion Criteria:
Male and female outpatients, aged 18-55 years
Subjects meeting full criteria for the diagnosis of DSM-IV (Diagnostic and Statistical Manual, Version 4) Attention Deficit Hyperactivity Disorder (ADHD)
Absence of pharmacological treatment for ADHD for at least one week.
Right handedness
Exclusion Criteria:
Any other current psychiatric or medical condition determined to be clinically significant.
Current use of psychotropics or any medication with clinically significant CNS (Central Nervous System) effects.
Mental retardation (IQ < 80).
Significant sensory deficits such as deafness or blindness.
Individuals with a history of substance dependence or abuse within the past 6 months.
Pregnant or nursing females.
Subjects with pre-existing structural cardiac abnormalities.
Clinically significant abnormal laboratory values, electrocardiogram or blood pressure reading
Healthy Control Subjects
Inclusion Criteria:
Males and females, aged 18-55 years
Subjects who do not meet full criteria for the diagnosis of DSM-IV Attention Deficit Hyperactivity Disorder (ADHD), as determined by clinical evaluation and/or ADHD module of structured diagnostic interview, completed by the study clinician.
Right handedness
Exclusion Criteria:
Any current psychiatric or medical condition determined to be clinically significant.
Current use of psychotropics or any medication with clinically significant CNS effects.
Mental retardation (IQ < 80).
Significant sensory deficits such as deafness or blindness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Biederman, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Diagnostic Utility of Attention Deficit Hyperactivity Disorder (ADHD) by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials
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