Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466310
Status:
COMPLETED
Last Update Posted:
2014-07-25
First Post:
2007-04-25
Brief Title:
Metabolic Signatures and Biomarkers in Schizophrenia
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Metabolic Signatures and Biomarkers in First Episode and Recurrent Patients With Schizophrenia in Comparison to Healthy Controls
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We plan to use a metabolomics lipid platform to map biochemical signatures in unmedicated schizophrenic patients prior to and 4 weeks post treatment with the antipsychotic drug aripiprazole and compare that to lipid perturbations induced by risperidone These drugs have inherently different risk for metabolic adverse effects and patients respond to them differently Metabolic signatures for the drugs capture significant biochemical information that could explain part of the basis for varied drug response within individuals and will highlight pathways implicated in drug action and in disease pathogenesis possibly enabling new drug design strategies In addition we will compare patients to healthy controls at baseline in regard lipid profiles
Detailed Description:
Schizophrenia SCH is a devastating mental disease that affects the human population worldwide with an incidence of about 1 Most individuals with this illness benefit from long-term pharmacotherapy however the therapeutic effects of antipsychotic treatment are inconsistent incomplete and often countered by significant side-effects associated with long-term physical morbidity eg tardive dyskinesia obesity hyperglycemia hyperlipidemia Metabolomics is a powerful new technology that provides a snap shot of biochemical pathways at a particular point in time It has been earmarked as an important area to develop under the NIH roadmap initiative We plan to use this platform to map biochemical signatures in unmedicated schizophrenic patients prior to and 4 weeks post treatment with the antipsychotic drug aripiprazole and compare that to lipid perturbations induced by risperidone These drugs have inherently different risk for metabolic adverse effects and patients respond to them differently Metabolic signatures for the drugs capture significant biochemical information that could explain part of the basis for varied drug response within individuals and will highlight pathways implicated in drug action and in disease pathogenesis possibly enabling new drug design strategiesIn addition we will compare patients to healthy controls at baseline in regard lipid profiles to assess whether lipid profiles differ between unmedicated schizophrenia patients and healthy controls
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 8370 | OTHER | Duke legacy protocol number | None |