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| Name | Class |
|---|---|
| ElMindA Ltd | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concerta | Experimental | Open-Label Concerta (Osmotic Release Methylphenidate) |
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| Control group | No Intervention | Healthy subjects without ADHD will be assessed using EEG. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osmotic Release Methylphenidate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 weeks |
| 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. | Single Point (Baseline) |
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ADHD Subjects
Inclusion Criteria:
Exclusion Criteria:
Healthy Control Subjects
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Biederman, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Controls without ADHD were assessed using EEG |
| FG001 | ADHD | Subjects with ADHD were assessed with EEG before and after treatment with Concerta |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Subjects without ADHD |
| BG001 | ADHD | Subjects with ADHD |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 weeks |
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| 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. | Only subjects that met the a priori pre-defined EEG signal quality criteria were included. | Posted | Number | percentage of errors | Single Point (Baseline) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Subjects without ADHD were assessed using EEG. | 0 | 33 | 0 | 33 | ||
| EG001 | ADHD | Subjects with ADHD were assessed with EEG before and after open-label treatment with Concerta. | 0 | 38 | 22 | 38 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Decreased Appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Dry Mouth | General disorders | Non-systematic Assessment |
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| Dulled Affect | Psychiatric disorders | Non-systematic Assessment |
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| Gastrointestinal Upset | Gastrointestinal disorders | Non-systematic Assessment |
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| Headache | General disorders | Non-systematic Assessment |
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| Racing Heart | Cardiac disorders | Non-systematic Assessment |
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| Increased Energy | General disorders | Non-systematic Assessment |
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| Irritability | General disorders | Non-systematic Assessment |
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| Jitteriness | General disorders | Non-systematic Assessment |
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| Tiredness | General disorders | Non-systematic Assessment |
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| Tension | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD | Massachusetts General Hospital | (617)-724-0006 | jbiederman@partners.org |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
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| Male |
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| OG003 | 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. |
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