Diagnostic Utility of Attention Deficit Hyperactivity Disorder (ADHD) by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Osmotic Release Methylphenidate
Intervention description: 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 MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ADHD; Adults; Electroencephalography (EEG); Concerta

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.