Attention Deficit Hyperactivity Disorder
Conditions
Keywords
ADHD, Adults, Electroencephalography (EEG), Concerta
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.
Interventions
DRUGOsmotic Release Methylphenidate
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.
Sponsors
ElMindA Ltd
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adult ADHD Investigator Symptom Rating Scale (AISRS) | Baseline and 6 weeks | 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 | Single Point (Baseline) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Subjects without ADHD | 33 |
| ADHD Subjects with ADHD | 38 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Found Ineligible During Screening | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 7 |
| Overall Study | Physician Decision | 0 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Control | ADHD |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 71 Participants | 33 Participants | 38 Participants |
| Age, Continuous | 34.0 years STANDARD_DEVIATION 10.8 | 32.2 years STANDARD_DEVIATION 11 | 35.5 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment United States | 71 participants | 33 participants | 38 participants |
| Sex: Female, Male Female | 30 Participants | 16 Participants | 14 Participants |
| Sex: Female, Male Male | 41 Participants | 17 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 22 / 38 |
| serious Total, serious adverse events | 0 / 33 | 0 / 38 |
Outcome results
Primary
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.
Time frame: Baseline and 6 weeks
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ADHD | Adult ADHD Investigator Symptom Rating Scale (AISRS) | Baseline | 37.0 units on a scale | Standard Deviation 8.7 |
| ADHD | Adult ADHD Investigator Symptom Rating Scale (AISRS) | 6 weeks | 15.0 units on a scale | Standard Deviation 9.4 |
Primary
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.
Time frame: Single Point (Baseline)
Population: Only subjects that met the a priori pre-defined EEG signal quality criteria were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ADHD | Percent Errors in Visual Go/NoGo Task | 19.01 percentage of errors |
| Controls | Percent Errors in Visual Go/NoGo Task | 13.89 percentage of errors |
| ADHD and Visual Go Task | Percent Errors in Visual Go/NoGo Task | 2.88 percentage of errors |
| Control Group and Visual Go Task | Percent Errors in Visual Go/NoGo Task | 1.27 percentage of errors |