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

NCT01063153 | Completed Phase 4 Results DMC

• 1 other identifier: 2009-P-000174
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Adults; Electroencephalography (EEG); Concerta

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

Concerta

EXPERIMENTAL

Open-Label Concerta (Osmotic Release Methylphenidate)

Drug: Osmotic Release Methylphenidate

Control group

NO INTERVENTION

Healthy subjects without ADHD will be assessed using EEG.

Interventions

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.

Also known as: Concerta

Concerta

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• ElMindA Ltd: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD
• Organization: Massachusetts General Hospital

jbiederman@partners.org

(617)-724-0006

Study Officials

• Joseph Biederman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 5, 2010
• Study Start: September 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: May 3, 2017
• Results First Posted: December 9, 2013

Record last verified: 2017-03

Locations

US (1)