CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 71 enrolled
Drug / intervention
Osmotic Release Methylphenidatedrug
Likely dose
Osmotic Release Methylphenidate 144 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01063153
NCT01063153Phase 4Completed

Diagnostic Utility of ADHD by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials

Massachusetts General Hospital·interventional·Posted Feb 5, 2010·Updated May 3, 2017

In Brief

A Phase 4 clinical trial evaluating Osmotic Release Methylphenidate for Attention Deficit Hyperactivity Disorder. Completed, enrolled 71 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsElMindA Ltd

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 5, 2010
Enrollment StartSep 1, 2009
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 16.4 years ago

Interventions

Osmotic Release Methylphenidatedrug

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.