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Electrophysiological Effects of Guanfacine Extended Release in Attention Deficit Hyperactivity Disorder (ADHD)

NCT ID: NCT01069523

Last Updated: 2012-09-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-08-31

Brief Summary

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All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will have an Event related potential (ERP) (a type of electroencephalogram \[EEG\]) study. After the baseline EEG, children will be randomized to either placebo or GXR for a 4-week, parallel groups trial. During this trial, dosing will be flexibly adjusted according to patient response or presence of side effects. The dosage will range from 1-4 mg. At the end of the four week trial, a follow up ERP study will be obtained.

Detailed Description

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All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will have an Event related potential (ERP) (a type of electroencephalogram \[EEG\]) study. After the baseline EEG, children will be randomized to either placebo or GXR for a 4-week, parallel groups trial. During this trial, dosing will be flexibly adjusted according to patient response or presence of side effects. The dosage will range from 1-4 mg. At the end of the four week trial, a follow up ERP study will be obtained. Our hypotheses are: A) GXR will be superior to placebo at reducing symptoms of ADHD as measured by standardized clinical diagnostic tools by week 3 of treatment. B) Compared to placebo and pretreatment measures, GXR at week 4 of treatment will increase the amplitude of the right frontal N200 and frontal-central P300, and such changes will correlate with clinical response.

Conditions

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Attention Deficit Disorder With Hyperactivity

Keywords

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Attention Deficit Disorder with Hyperactivity Guanfacine Event Related Potentials

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Table that match the 1 mg Guanfacine Extended Release Tablet. They are dosed once a day.

Guanfacine Extended Release

Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).

Group Type EXPERIMENTAL

Guanfacine Extended Release

Intervention Type DRUG

Guanfacine is an alpha-2A agonist which is given one a day. the dose range is 1-4 mg. It is a tablet.

Interventions

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Guanfacine Extended Release

Guanfacine is an alpha-2A agonist which is given one a day. the dose range is 1-4 mg. It is a tablet.

Intervention Type DRUG

Placebo

Table that match the 1 mg Guanfacine Extended Release Tablet. They are dosed once a day.

Intervention Type DRUG

Other Intervention Names

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Intuniv

Eligibility Criteria

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Inclusion Criteria

* Children aged 6-12 years
* Meet criteria for Attention Deficit Hyperactivity Disorder

Exclusion Criteria

* Do not meet criteria for Major Depression, Bipolar, Autism
* Talking any psychotropic medication for a condition other than ADHD
* History of epilepsy, severe head injury or loss of consciousness
* History of Intolerance to guanfacine
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shire

INDUSTRY

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven R Pliszka, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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Dept. Of Psychiatry, University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC2009-499H

Identifier Type: -

Identifier Source: org_study_id