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

March 30, 2017 updated by: Joseph Biederman, MD, Massachusetts General Hospital

Diagnostic Utility of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Concerta
Open-Label Concerta (Osmotic Release Methylphenidate)
Drug: Osmotic 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.
Other Names:
  • Concerta
No Intervention: Control group
Healthy subjects without ADHD will be assessed using EEG.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 6 weeks
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.
Single Point (Baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

ElMindA Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

February 3, 2010

First Submitted That Met QC Criteria

February 4, 2010

First Posted (Estimate)

February 5, 2010

Study Record Updates

Last Update Posted (Actual)

May 3, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-P-000174

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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