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Diagnostic Utility of Attention Deficit Hyperactivity Disorder (ADHD) by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials - NCT01063153-02138(Clinical Trial 493615)



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City:  Cambridge
State:  
MA
Zip Code: 02138
Conditions: Attention Deficit Hyperactivity Disorder
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.
Study summary:
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.
Study is available at: Massachusetts General Hospital
Cambridge, MA 02138
United States

Primary Contact:
Kristin Brethel, BS
Email: kbrethel@partners.org
Phone: 617-503-1459

Secondary Contact:
Kristin Brethel, BS
Email: kbrethel@partners.org
Phone: 617-503-1459
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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