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NCT00466310 · ClinicalTrials.gov registry record · Phase 1
Metabolic Signatures and Biomarkers in Schizophrenia
A Phase 1 study of Schizophrenia, sponsored by Duke University.
- Completed
- Registry status
- Phase 1
- Development phase
- 71
- Enrollment target
- 1
- Study location
NCT00466310: Completed Phase 1 study of Schizophrenia, sponsored by Duke University.
NCT00466310 is a Phase 1 study of Schizophrenia that has completed, run by Duke University. The registered enrollment target is 71 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00466310, a Phase 1 study of Schizophrenia, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 71 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Plasmalogens are a subclass of glycerophospholipids and ubiquitous constituents of cellular membranes and serum lipoproteins. Several neurological disorders show decreased level of plasmalogens.
Conditions Studied
Interventions
- DRUG Risperidone
- DRUG Aripiprazole
- OTHER Healthy volunteers
Study Locations (1)
North Carolina
- John Umstead Hospital - Butner
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2007-02 |
| Est. Completion | 2011-01 |
| Phase | Phase 1 |
What the finished NCT00466310 record still lists
NCT00466310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (68% lower).
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 3 interventions - of which Risperidone is the first listed.
NCT00466310 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00466310 about?
NCT00466310 is a clinical study titled "Metabolic Signatures and Biomarkers in Schizophrenia". 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...
What is the current status of trial NCT00466310?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2007-02. Estimated completion is 2011-01.
What conditions does trial NCT00466310 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT00466310?
The interventions under investigation include: Risperidone (DRUG), Aripiprazole (DRUG), Healthy volunteers (OTHER).
Who is sponsoring clinical trial NCT00466310?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00466310 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00466310's enrollment target sits among peer trials
71 174th of 315 higher than 141 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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