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

NCT ID: NCT01063153

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-02-29

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Concerta

Open-Label Concerta (Osmotic Release Methylphenidate)

Group Type: EXPERIMENTAL

Osmotic Release Methylphenidate

Intervention Type: 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.

Control group

Healthy subjects without ADHD will be assessed using EEG.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Concerta

Eligibility Criteria

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

• 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 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ElMindA Ltd

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joseph Biederman, MD

Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Biederman, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2009-P-000174

Identifier Type: -

Identifier Source: org_study_id