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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 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.

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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.

Conditions Studied

Interventions

  • DRUG Risperidone
  • DRUG Aripiprazole
  • OTHER Healthy volunteers

Study Locations (1)

North Carolina

  • John Umstead Hospital - Butner

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2007-02
Est. Completion 2011-01
Phase Phase 1

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT00466310

The ClinicalTrials.gov registry entry for NCT00466310 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (68% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.