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Metabolic Signatures and Biomarkers in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00466310
First received: April 25, 2007
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
Results First Received: April 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Aripiprazole
Drug: Risperidone
Other: Healthy volunteers

  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

Unmedicated patients treated for a first psychotic episode (n = 20), and patients treated for psychotic relapse of schizophrenia or schizoaffective disorder(n = 20).

Controls who had no personal history of psychotic illness or relatives with psychotic illnesses,(n = 31). Individuals receiving treatment for diabetes or hyperlipidemia were excluded.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
First Episode Schizophrenics Schizophrenia subjects with no prior episodes
Recurrent Episode Schizophrenics Schizophrenia subjects with at least one prior episode
Healthy Volunteers Fasting blood samples were drawn at baseline from 31 healthy matched controls.

Participant Flow:   Overall Study
    First Episode Schizophrenics     Recurrent Episode Schizophrenics     Healthy Volunteers  
STARTED     20     20     31  
COMPLETED     20     20     31  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
First Episode Schizophrenics These are subjects with no prior schizophrenic episodes
Recurrent Episode Schizophrenics These subjects have had at least one prior schizophrenic episode.
Healthy Volunteers Fasting blood samples were drawn at baseline from 31 healthy matched controls.
Total Total of all reporting groups

Baseline Measures
    First Episode Schizophrenics     Recurrent Episode Schizophrenics     Healthy Volunteers     Total  
Number of Participants  
[units: participants]
 		  20     20     31     71  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     20     20     31     71  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  27  ± 9.8     36.6  ± 12.7     37.9  ± 9.1     33.63  ± 11.6  
Gender  
[units: participants]
 		       
Female     7     5     25     37  
Male     13     15     6     34  
Region of Enrollment  
[units: participants]
 		       
United States     20     20     31     71  



  Outcome Measures

1.  Primary:   Total Plasmalogen Levels in the Lipid Profile   [ Time Frame: Baseline ]
  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:  
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
Limited to patients admitted to Psychiatric facility  


Results Point of Contact:  
Name/Title: Rima Kaddurah-Douk, Associate Professor
Organization: DUMC
phone: 919-684-2611
e-mail: rima.kaddurah-daouk@duke.edu


Publications of Results:

Other Publications:


Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00466310     History of Changes
Other Study ID Numbers: Pro00008577 (8370)
Study First Received: April 25, 2007
Results First Received: April 5, 2011
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board