drugset / Trial / NCT00466310

Metabolic Signatures and Biomarkers in Schizophrenia

NCT00466310

Phase 1 Completed 71 enrolled Duke University Bristol-Myers Squibb · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2007-02
Primary completion
2009-01
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aripiprazole Other / unclassified
Comparator Risperidone Other / unclassified

Indications