Phase 4 N=71 Diagnostic

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

Attention Deficit Hyperactivity Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01063153 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2013

Primary outcome: Primary: Adult ADHD Investigator Symptom Rating Scale (AISRS) — 37.0; 15.0 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Osmotic Release Methylphenidate (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Feb 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Adult ADHD Investigator Symptom Rating Scale (AISRS)	37.0; 15.0	—
PRIMARY Percent Errors in Visual Go/NoGo Task	19.01; 13.89; 2.88; 1.27	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01063153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.