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

This study has been completed.
Sponsor:
Collaborator:
ElMindA Ltd
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01063153
First received: February 3, 2010
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: Osmotic Release Methylphenidate
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diagnostic Utility of ADHD by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Adult ADHD Investigator Symptom Rating Scale (AISRS) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Brain Activity Flow Patterns Analysis (BAFPA) [ Time Frame: Single Point (Baseline) ] [ Designated as safety issue: No ]
    Brain Activity Flow Patterns are electrical networks in the brain that activate in response to a given stimulus (i.e. a computer task)


Enrollment: 71
Study Start Date: September 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Concerta
No Intervention: Control group
Healthy subjects without ADHD will be assessed using EEG.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01063153

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
ElMindA Ltd
Investigators
Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Joseph Biederman, MD, Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01063153     History of Changes
Other Study ID Numbers: 2009-P-000174
Study First Received: February 3, 2010
Results First Received: June 12, 2013
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
ADHD
Adults
Electroencephalography (EEG)
Concerta

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014