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Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder

This study has been completed.
Sponsor:
Collaborators:
Emory University
Massachusetts General Hospital
Seattle Children's Hospital
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01238575
First received: October 29, 2010
Last updated: October 30, 2015
Last verified: September 2015
Results First Received: April 30, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pervasive Development Disorders
Interventions: Other: placebo
Drug: extended-release guanfacine

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
81 total patients screened. 13 ineligible. 6 Declined

Reporting Groups
  Description
Extended-release Guanfacine extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
Inactive Placebo placebo: Administered for up to 8 weeks.

Participant Flow:   Overall Study
    Extended-release Guanfacine     Inactive Placebo  
STARTED     30     32  
COMPLETED     26     28  
NOT COMPLETED     4     4  
Lack of Efficacy                 2                 4  
Adverse Event                 2                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Extended-release Guanfacine extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
Inactive Placebo placebo: Administered for up to 8 weeks.
Total Total of all reporting groups

Baseline Measures
    Extended-release Guanfacine     Inactive Placebo     Total  
Number of Participants  
[units: participants]
  30     32     62  
Age  
[units: years]
Mean (Standard Deviation)
  8.44  (2.28)     8.39  (2.23)     8.4  (2.25)  
Gender  
[units: participants]
     
Female     4     5     9  
Male     26     27     53  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     4     1     5  
Native Hawaiian or Other Pacific Islander     1     1     2  
Black or African American     7     4     11  
White     17     23     40  
More than one race     1     3     4  
Unknown or Not Reported     0     0     0  



  Outcome Measures
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1.  Primary:   Aberrant Behavior Checklist Hyperactivity Subscale   [ Time Frame: Week 8 ]

2.  Secondary:   ADHD Rating Scale - Total   [ Time Frame: Week 8 ]

3.  Secondary:   Aberrant Behavior Checklist Irritability Subscale   [ Time Frame: 8 weeks ]

4.  Secondary:   Aberrant Behavior Checklist Social Withdrawal Subscale   [ Time Frame: 8 weeks ]

5.  Secondary:   Aberrant Behavior Checklist Sterotypy Subscale   [ Time Frame: 8 weeks ]

6.  Secondary:   Aberrant Behavior Checklist Inappropriate Speech Subscale   [ Time Frame: 8 weeks ]

7.  Secondary:   ADHD Rating Scale - Inattention Subscale   [ Time Frame: 8 weeks ]

8.  Secondary:   ADHD Rating Scale - Hyperactivity Subscale   [ Time Frame: 8 weeks ]

9.  Secondary:   Aberrant Behavior Checklist Hyperactivity Subscale   [ Time Frame: Baseline ]

10.  Secondary:   Aberrant Behavior Checklist Irritability Subscale   [ Time Frame: Baseline ]

11.  Secondary:   Aberrant Behavior Checklist Social Withdrawal Subscale   [ Time Frame: Baseline ]

12.  Secondary:   Aberrant Behavior Checklist Sterotypy Subscale   [ Time Frame: Baseline ]

13.  Secondary:   Aberrant Behavior Checklist Inappropriate Speech Subscale   [ Time Frame: Baseline ]

14.  Secondary:   ADHD Rating Scale - Inattention Subscale   [ Time Frame: Baseline ]

15.  Secondary:   ADHD Rating Scale - Hyperactivity Subscale   [ Time Frame: Baseline ]

16.  Secondary:   ADHD Rating Scale - Total   [ Time Frame: Baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  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.


Results Point of Contact:  
Name/Title: Lawrence Scahill, MSN, PhD
Organization: Emory University
e-mail: lawrence.scahill@emory.edu


Publications:

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01238575     History of Changes
Other Study ID Numbers: R01MH083707 ( US NIH Grant/Contract Award Number )
Study First Received: October 29, 2010
Results First Received: April 30, 2015
Last Updated: October 30, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board