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Pharmacogenomics in Autism Treatment (PG)

This study has been completed.
Sponsor:
Collaborators:
Janssen, LP
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00584701
First received: December 22, 2007
Last updated: June 18, 2012
Last verified: June 2012
History of Changes
Results First Received: September 6, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Autism
Intervention: Drug: Risperidone

  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
Participants recruitment at the UCDavis MIND Institute from the local community.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Active Risperidone Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.

Participant Flow for 2 periods

 Period 1:   Active Risperidone
    Active Risperidone  
STARTED     49  
COMPLETED     46  
NOT COMPLETED     3  

Period 2:   Follow-up
    Active Risperidone  
STARTED     46  
COMPLETED     34  
NOT COMPLETED     12  



  Baseline Characteristics
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  Outcome Measures
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1.  Primary:   Percent Change of ABC - Irritability Subscale Score   [ Time Frame: Baseline, 8 weeks ]
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2.  Secondary:   Exon Expression Positively or Negatively Correlated With Percentage Improvement in ABC-I   [ Time Frame: Baseline, 8 Weeks ]
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  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
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Results Point of Contact:  
Name/Title: Robert Hendren, DO
Organization: UCSF
phone: 415-476-7198
e-mail: robert.hendren@ucsf.edu


No publications provided


Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00584701     History of Changes
Other Study ID Numbers: 200715817-1, R21MH080026
Study First Received: December 22, 2007
Results First Received: September 6, 2011
Last Updated: June 18, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board