CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 96 enrolled
Drug / intervention
risperidone +3 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/NCT00515723
NCT00515723N/ACompleted

Glucose and Lipid Metabolism on Antipsychotic Medication

Washington University School of Medicine·interventional·Posted Aug 14, 2007·Updated Oct 2, 2019

In Brief

A clinical study evaluating risperidone, olanzapine, and 2 other interventions for Schizophrenia and 3 related conditions. Completed, enrolled 96 participants across 2 sites.

Detailed Summary

This project aims to a) evaluate the effects of selected antipsychotic medications on insulin action in skeletal muscle (glucose disposal), liver (glucose production) and adipose tissue (whole-body lipolysis), b) evaluate the effects of selected antipsychotic medications on abdominal adipose tissue mass, total body fat and total fat-free mass, and c) explore the longitudinal effects of treatment with selected antipsychotics on glucose tolerance, lipid profiles, abdominal adipose tissue mass, total body fat and total fat-free mass. These hypotheses will be evaluated by measuring 1) whole-body glucose and lipid kinetics with the use of "gold-standard" stable isotope tracer methodology, 2) body composition using dual energy x-ray absorptiometry and magnetic resonance imaging, and 3) longitudinal changes in glucose tolerance and lipid profiles. The aims will be addressed in non-diabetic schizophrenia patients chronically treated with risperidone, olanzapine, clozapine, quetiapine, ziprasidone, or haloperidol, and untreated healthy controls. Re-evaluations will also be performed in patients who are randomized to switch from their current antipsychotic (from the above groups) to risperidone, olanzapine, quetiapine, or ziprasidone for 6 months. Relevant data is critically needed to target basic research, identify long-term cardiovascular consequences, and plan therapeutic interventions.

Study Details

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

Timeline

N/ACompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 14, 2007
Enrollment StartSep 1, 2001
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 18.9 years ago

Interventions

risperidonedrug

randomized to 12 week trial of risperidone.

olanzapinedrug

randomized to 12 week trial of olanzapine.

quetiapinedrug

randomized to 12 week trial of quetiapine.

ziprasidonedrug

randomized to 12 week trial of ziprasidone.