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