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

Study Overview
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Brief Summary
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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.

Official Title
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Diagnostic Utility of ADHD by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: Osmotic Release Methylphenidate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concerta<br>Open-Label Concerta (Osmotic Release Methylphenidate) | Drug: Osmotic Release Methylphenidate<br>* 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.<br>* Other names: Concerta;|
| No Intervention: Control group<br>Healthy subjects without ADHD will be assessed using EEG. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Electroencephalography (EEG), Concerta, Adults