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Completed

NCT Number: NCT01063153

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

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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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Concerta

Primary outcomes

  1. Adult ADHD Investigator Symptom Rating Scale (AISRS)

    Time frame: 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.

  2. Percent Errors in Visual Go/NoGo Task

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • ElMindA Ltd

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Feb 5, 2010
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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