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

This study has been completed.
Sponsor:
Collaborator:
Shire Development LLC
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01069523
First received: February 15, 2010
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
Results First Received: June 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Attention Deficit Disorder With Hyperactivity
Interventions: Drug: Guanfacine Extended Release
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from 4/2010 through 6/2011 primarily through flyers in child psychiatry clinics and by informing families who called the clinic intake line.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After diagnostic assessment and confirmation that subjects meet study criteria, subjects were scheduled for a baseline EEG and they performed the Stop Signal Task while ERP data was obtained. 42 subjects completed baseline evaluation,13 did not complete baseline EEG, leaving 29 to be randomized to drug

Reporting Groups
  Description
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).
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).

Participant Flow:   Overall Study
    Placebo     Guanfacine Extended Release  
STARTED     13     16  
COMPLETED     9     9  
NOT COMPLETED     4     7  
Withdrawal by Subject                 4                 7  



  Baseline Characteristics
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Reporting Groups
  Description
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).
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).
Total Total of all reporting groups

Baseline Measures
    Placebo     Guanfacine Extended Release     Total  
Number of Participants  
[units: participants]
 		  13     16     29  
Age  
[units: participants]
 		     
<=18 years     13     16     29  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  8.78  ± 1.8     7.8  ± 1.2     8.29  ± 1.5  
Gender  
[units: participants]
 		     
Female     7     6     13  
Male     6     10     16  
Region of Enrollment  
[units: participants]
 		     
United States     13     16     29  



  Outcome Measures
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1.  Primary:   Dupaul ADHD Rating Scale   [ Time Frame: Baseline and Follow up ]
  Show Outcome Measure 1

2.  Secondary:   Clinical Global Impression- Improvement   [ Time Frame: Week 4 of study ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:  
Name/Title: Steven R.Pliszka MD
Organization: University of Texas Health Science Center at San Antonio
phone: 210-567-5475
e-mail: pliszka@uthscsa.edu


No publications provided


Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01069523     History of Changes
Other Study ID Numbers: HSC2009-499H
Study First Received: February 15, 2010
Results First Received: June 14, 2012
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration