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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 206-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • DRUG Osmotic Release Methylphenidate

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2009-09
Est. Completion 2012-02
Phase Phase 4

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT01063153

The ClinicalTrials.gov registry entry for NCT01063153 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 206-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (66% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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