Diagnostic Utility of Attention Deficit Hyperactivity Disorder (ADHD) by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials
This study has been completed.
Sponsor:
Massachusetts General Hospital
Collaborator:
ElMindA Ltd
Information provided by (Responsible Party):
Paul Hammerness, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01063153
First received: February 3, 2010
Last updated: August 22, 2012
Last verified: August 2012
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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: Single Group 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:
- Brain activity flow patterns analysis (BAFPA) during a Go/NoGo task in the diagnosis of ADHD in adults [ Time Frame: Week 99 (start of study), Week 0 (two hours after first dose of medication), Week 6 ] [ Designated as safety issue: No ]
| 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) |
Intervention Details:
-
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
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 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 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 More Information
No publications provided
| Responsible Party: | Paul Hammerness, MD, Assistant Psychiatrist, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01063153 History of Changes |
| Other Study ID Numbers: | 2009-P-000174 |
| Study First Received: | February 3, 2010 |
| Last Updated: | August 22, 2012 |
| 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 May 19, 2013