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

NCT01069523 | Completed Phase 4 Results DMC

• 1 other identifier: HSC2009-499H
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention Deficit Disorder with Hyperactivity; Guanfacine; Event Related Potentials

Outcome Measures

Primary Outcomes (1)

• Dupaul ADHD Rating Scale

  54 point scales assessing ADHD symptoms in a dimensional manner. 0 is no ADHD symptoms while 54 is severe. A score of 18 or below is the normative range.

  Baseline and Follow up

Secondary Outcomes (1)

• Clinical Global Impression- Improvement

  Week 4 of study

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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).

Drug: Placebo

Guanfacine Extended Release

EXPERIMENTAL

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).

Drug: Guanfacine Extended Release

Interventions

Guanfacine Extended Release DRUG

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

Also known as: Intuniv

Guanfacine Extended Release

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Shire: collaborator

Study Sites (1)

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

San Antonio, Texas, 78229-3900, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Guanfacine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Limitations and Caveats

The intent of the study was to examine ERP waveforms associated with impulse control. Unfortuanately, the Stop signal task and EEG proved very difficult for this young group of subjects. The ERP data could not be fully analyzed and is not reported.

Results Point of Contact

• Title: Steven R.Pliszka MD
• Organization: University of Texas Health Science Center at San Antonio

pliszka@uthscsa.edu

210-567-5475

Study Officials

• Steven R Pliszka, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2010
• First Posted: February 17, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: September 3, 2012
• Results First Posted: September 3, 2012

Record last verified: 2012-08

Locations

US (1)