FMRI Brain Activation of Aripiprazole Treatment in Autism Spectrum Disorders (AripfMRI)

This study has been completed.
Sponsor:
Collaborators:
Duke University
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01028820
First received: December 4, 2009
Last updated: February 7, 2014
Last verified: February 2014
Results First Received: November 7, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Autism Spectrum Disorder
Intervention: Drug: Aripiprazole

  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
We planned to recruit participants through the NDRC Registry and Division TEACCH, as well as utilizing radio and television ads on various stations. We also posted brochures and flyers in public locations and attended conferences in order to hand out study-specific information. 13 subjects began the study and only one of those failed to complete.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In order to participate in the research study, subjects must have been washed out from psychoactive medication for at least one month for fluoxetine, two weeks for other SSRIs and neuroleptics and five days for stimulants prior to MRI scanning, with the exception of stable doses greater than three months duration of medication for seizure disorder.

Reporting Groups
  Description
Open-Label, Flexible-Dose Aripiprazole

This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.

Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily


Participant Flow:   Overall Study
    Open-Label, Flexible-Dose Aripiprazole  
STARTED     13  
COMPLETED     12  
NOT COMPLETED     1  



  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
Open-Label, Flexible-Dose Aripiprazole

This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.

Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily


Baseline Measures
    Open-Label, Flexible-Dose Aripiprazole  
Number of Participants  
[units: participants]
  13  
Age  
[units: years]
Mean ± Standard Deviation
  20.31  ± 5.1  
Gender  
[units: participants]
 
Female     1  
Male     12  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     3  
White     9  
More than one race     0  
Unknown or Not Reported     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Baseline and Week 8scores on Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version   [ Time Frame: Baseline ("Pre-Dose") to 8 Weeks ("Post-Dose") ]

2.  Secondary:   Total Repetitive Behavior Scale - Revised (RBS_R)   [ Time Frame: baseline week 0, 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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 present study had 13 subjects. Due to sample size, analysis reflected an exploratory approach. If a mechanism for predicting RRB improvement is found in a study with a larger N, we could better understand therapies targeting core symptoms of ASD.  


Results Point of Contact:  
Name/Title: Linmarie Sikich, M.D.
Organization: The University of North Carolina at Chapel Hill
phone: (919) 972-7499
e-mail: lsikich@med.unc.edu


No publications provided


Responsible Party: Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01028820     History of Changes
Other Study ID Numbers: 090795, K23MH081285
Study First Received: December 4, 2009
Results First Received: November 7, 2012
Last Updated: February 7, 2014
Health Authority: United States: Institutional Review Board