CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 71 enrolled
Drug / intervention
Aripiprazole +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00466310
NCT00466310Phase 1Completed

Metabolic Signatures and Biomarkers in First Episode and Recurrent Patients With Schizophrenia in Comparison to Healthy Controls

Duke University·interventional·Posted Apr 27, 2007·Updated Jul 25, 2014

In Brief

A Phase 1 clinical trial evaluating Aripiprazole, Risperidone, and 1 other intervention for Schizophrenia. Completed, enrolled 71 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States

Timeline

Phase 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 27, 2007
Enrollment StartFeb 1, 2007
Primary CompletionJan 1, 2009
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 19.2 years ago

Interventions

Aripiprazoledrug

Aripiprazole for 4 weeks

Risperidonedrug

Subjects will be randomized to risperidone for 4 weeks

Healthy volunteersother

Healthy volunteers