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NCT01063153 · ClinicalTrials.gov registry record · Phase 4
Diagnostic Utility of Attention Deficit Hyperactivity Disorder (ADHD) by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials
A Phase 4 study of Attention Deficit Hyperactivity Disorder, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 71
- Enrollment target
- 1
- Study location
NCT01063153: Completed Phase 4 study of Attention Deficit Hyperactivity Disorder, sponsored by Massachusetts General Hospital.
NCT01063153 is a Phase 4 study of Attention Deficit Hyperactivity Disorder that has completed, run by Massachusetts General Hospital. The registered enrollment target is 71 participants, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01063153, a Phase 4 study of Attention Deficit Hyperactivity Disorder, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 71 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Osmotic Release Methylphenidate
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2009-09 |
| Est. Completion | 2012-02 |
| Phase | Phase 4 |
What the finished NCT01063153 record still lists
NCT01063153 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 1 intervention - of which Osmotic Release Methylphenidate is the first listed.
NCT01063153 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01063153 about?
NCT01063153 is a clinical study titled "Diagnostic Utility of Attention Deficit Hyperactivity Disorder (ADHD) by Brain Activity Flow Patterns Analysis Using Evoked Response Potentials". 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...
What is the current status of trial NCT01063153?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 71 participants. The study started on 2009-09. Estimated completion is 2012-02.
What conditions does trial NCT01063153 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder.
What interventions are being tested in trial NCT01063153?
The interventions under investigation include: Osmotic Release Methylphenidate (DRUG).
Who is sponsoring clinical trial NCT01063153?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01063153 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Attention Deficit Hyperactivity Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01063153's enrollment target sits among peer trials
71 52nd of 102 higher than 51 of 102 other Attention Deficit Hyperactivity Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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