Metabolic Signatures and Biomarkers in Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00466310|
Recruitment Status : Completed
First Posted : April 27, 2007
Results First Posted : January 3, 2013
Last Update Posted : July 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Aripiprazole Drug: Risperidone Other: Healthy volunteers||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metabolic Signatures and Biomarkers in First Episode and Recurrent Patients With Schizophrenia in Comparison to Healthy Controls|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2011|
Active Comparator: Aripiprazole for 4 weeks
Blood is drawn for baseline. 20 Subjects are randomly assigned to receive Aripiprazole for weeks weeks with a starting dose of 10mg/day and the dose will be titrated to a maximum of 30mg /day based on effectiveness and tolerability. After 4 weeks of treatment, blood will be drawn again for metabolomics.
Aripiprazole for 4 weeks
Other Name: Abilify
Active Comparator: Risperidone for 4 weeks
Blood will be drawn for baseline evaluation. 20 Subjects will be randomly assigned to receive risperidone at a starting dose of 2mg/day, and can be increased to 6mg/day based on response of the subject. After 4 weeks of medication, blood is drawn again.
Subjects will be randomized to risperidone for 4 weeks
Other Name: Risperdal
Fasting blood samples will be drawn from healthy volunteers to match age, race and gender with the research subjects for comparison.
Other: Healthy volunteers
- Total Plasmalogen Levels in the Lipid Profile [ Time Frame: Baseline ]Plasmalogens are a subclass of glycerophospholipids and ubiquitous constituents of cellular membranes and serum lipoproteins. Several neurological disorders show decreased level of plasmalogens.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00466310
|United States, North Carolina|
|John Umstead Hospital|
|Butner, North Carolina, United States, 27509|
|Principal Investigator:||Rima Kaddurah-Daouk, MD||Duke University|