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The Effects of Aripiprazole on the Processing of Rewards in Schizophrenia

This study has been terminated.
(difficulty with technical aspect of fMRI, resources to complete the study ran out)
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Erica Duncan, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00209027
First received: September 13, 2005
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
Results First Received: April 13, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Schizophrenia
Interventions: Other: fMRI
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
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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
Schizophrenia Subjects Baseline fMRI, switch from baseline medication to aripiprazole, then repeat fMRI scan after 12 weeks of treatment.
Controls Baseline fMRI scan

Participant Flow:   Overall Study
    Schizophrenia Subjects     Controls  
STARTED     10     10  
COMPLETED     0     10  
NOT COMPLETED     10     0  
study terminated                 10                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Schizophrenia Subjects Baseline fMRI, switch from baseline medication to aripiprazole, then repeat fMRI scan after 12 weeks of treatment.
Controls Baseline fMRI scan
Total Total of all reporting groups

Baseline Measures
    Schizophrenia Subjects     Controls     Total  
Number of Participants  
[units: participants]
 		  10     10     20  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     10     10     20  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  42.5  ± 10.9     38.6  ± 7.2     40.6  ± 9.0  
Gender  
[units: participants]
 		     
Female     0     0     0  
Male     10     10     20  
Region of Enrollment  
[units: participants]
 		     
United States     10     10     20  



  Outcome Measures

1.  Primary:   BOLD Activation During fMRI Scanning During Performance of a Monetary Reward Task   [ Time Frame: Baseline and 12 weeks ]
  Show Outcome Measure 1


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
Although the study was planned as a repeated measures study with fMRI testing at baseline and after 3 months, difficulty with recruitment and technical difficulties with obtaining fMRI data relegated the study to a single baseline timepoint.  


Results Point of Contact:  
Name/Title: Erica Duncan
Organization: Emory University
phone: 404-321-6111 ext 7532
e-mail: erica.duncan@va.gov


Publications:
Friston KJ, Ashburner J, Frith CD, Poline J-B, Heather JD, Frackowiak RSJ (1995) Spatial registration and normalization of images. Hum Brain Mapp 2:1-25


Responsible Party: Erica Duncan, MD, Emory University
ClinicalTrials.gov Identifier: NCT00209027     History of Changes
Other Study ID Numbers: 570-024
Study First Received: September 13, 2005
Results First Received: April 13, 2012
Last Updated: June 15, 2012
Health Authority: United States: Food and Drug Administration