Metabolic Signatures and Biomarkers in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00466310
Recruitment Status : Completed
First Posted : April 27, 2007
Results First Posted : January 3, 2013
Last Update Posted : July 25, 2014
Bristol-Myers Squibb
Information provided by (Responsible Party):
Duke University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Aripiprazole
Drug: Risperidone
Other: Healthy volunteers

  Participant Flow

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
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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 20   20   31   71 
[Units: Participants]
<=18 years   0   0   0   0 
Between 18 and 65 years   20   20   31   71 
>=65 years   0   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 27  (9.8)   36.6  (12.7)   37.9  (9.1)   33.63  (11.6) 
[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 ]

  Serious Adverse Events

  Other Adverse Events

  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

  More Information

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

Results Point of Contact:  
Name/Title: Rima Kaddurah-Douk, Associate Professor
Organization: DUMC
phone: 919-684-2611

Publications of Results:
Other Publications:

Responsible Party: Duke University Identifier: NCT00466310     History of Changes
Other Study ID Numbers: Pro00008577
8370 ( Other Identifier: Duke legacy protocol number )
First Submitted: April 25, 2007
First Posted: April 27, 2007
Results First Submitted: April 5, 2011
Results First Posted: January 3, 2013
Last Update Posted: July 25, 2014