Clinical trial NCT01063153: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Adults
Electroencephalography (EEG)
Concerta
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: ElMindA Ltd
First posted: 2010-02-05
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Adult ADHD Investigator Symptom Rating Scale (AISRS)
timeFrame: Baseline and 6 weeks
measure: Percent Errors in Visual Go/NoGo Task
timeFrame: Single Point (Baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Joseph Biederman, MD
role: PRINCIPAL_INVESTIGATOR
References: