Phase 1
N=71
Metabolic Signatures and Biomarkers in Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00466310 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Total Plasmalogen Levels in the Lipid Profile — 57.65; 59.57; 75 nmoles/gram — p=0.0149
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Aripiprazole (Drug); Risperidone (Drug); Healthy volunteers (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Plasmalogen Levels in the Lipid Profile |
57.65; 59.57; 75 | 0.0149 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18-60 years
- Diagnosis of schizophrenia
- Actively psychotic
- No more than a single dose of antipsychotic in the preceding 2 weeks
Exclusion Criteria
- Mental retardation, epilepsy or history of head trauma
- Substance use disorder that explains the majority of the psychopathology
- Pregnant or lactating females
Data sourced from ClinicalTrials.gov (NCT00466310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.