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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01063153
• Other study ID #: 2009-P-000174
• Status: Completed
• Phase: Phase 4
• First received: February 3, 2010
• Last updated: September 21, 2015
• Start date: September 2009
• Est. completion date: February 2012

Study information

• Verified date: September 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	ElMindA Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Brain Activity Flow Patterns Analysis (BAFPA)	Brain Activity Flow Patterns are electrical networks in the brain that activate in response to a given stimulus (i.e. a computer task)	Single Point (Baseline)	No