CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
rosiglitazone +1 moredrug
Likely dose
rosiglitazone 4mgfrom 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/NCT00337350
NCT00337350Phase 4Completed

A Double-Blind, Placebo-Controlled Trial of Rosiglitazone for Clozapine Induced Glucose Metabolism Impairment: Bergman's Minimal Model Analysis

Massachusetts General Hospital·interventional·Posted Jun 15, 2006·Updated May 8, 2015

In Brief

A Phase 4 clinical trial evaluating rosiglitazone and placebo for Schizophrenia. Completed, enrolled 20 participants across 1 site.

Detailed Summary

We propose an eight-week, double-blind, placebo-controlled trial of rosiglitazone in schizophrenia subjects treated with clozapine using Bergman's Minimal Model (MINMOD) intravenous glucose tolerance test. Bergman's Minimal Model analysis with frequent sampled intravenous glucose tolerance test (FSIVGTT) provides a sensitive and reliable method to measure glucose effectiveness, insulin secretion and insulin sensitivity. The MINMOD determines the relationship between insulin sensitivity, insulin secretion and the degree of obesity and can be used to study drug effects upon these variables.

Study Details

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

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 15, 2006
Enrollment StartSep 1, 2003
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 20.0 years ago

Interventions

rosiglitazonedrug

Rosiglitazone 4mg, one capsule per day for eight weeks

placebodrug

matched placebo for rosiglitazone 4mg/day