Diagnostic Utility of Attention Deficit Hyperactivity Disorder (ADHD) by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials
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|ClinicalTrials.gov Identifier: NCT01063153|
Recruitment Status : Completed
First Posted : February 5, 2010
Results First Posted : December 9, 2013
Last Update Posted : May 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: Osmotic Release Methylphenidate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnostic Utility of ADHD by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Open-Label Concerta (Osmotic Release Methylphenidate)
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
No Intervention: Control group
Healthy subjects without ADHD will be assessed using EEG.
- Adult ADHD Investigator Symptom Rating Scale (AISRS) [ Time Frame: Baseline and 6 weeks ]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.
- Percent Errors in Visual Go/NoGo Task [ Time Frame: Single Point (Baseline) ]The Go/NoGo visual task was completed by subjects with ADHD as well as healthy controls. The Go/NoGo task is used to assess inhibitory control, and targets response inhibition, executive functions, and sustained attention. The 'Go' stimulus occupies 80% of the trials, and requires the subject to perform a motor response each time it appears on the screen. A rare 'No Go' stimulus (occupies 20% of all trials) requires the subject to refrain from responding. The percentage of errors were measured for each group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063153
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Joseph Biederman, MD||Massachusetts General Hospital|