Insulin Sensitivity in Patients With Schizophrenia or Schizoaffective Disorder Treated With Olanzapine and Risperidone

Eli Lilly and Company1 site in 1 country130 target enrollmentOctober 2003

ConditionsSchizophrenia Schizoaffective Disorder

Interventionsolanzapine risperidone

Drugsolanzapine risperidone

Overview

Phase: Phase 4
Intervention: olanzapine
Conditions: Schizophrenia
Sponsor: Eli Lilly and Company
Enrollment: 130
Locations: 1
Primary Endpoint: Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will assess whether olanzapine and/or risperidone affect the way the human body uses sugar in the blood.

Registry

clinicaltrials.gov

Start Date

October 2003

End Date

June 2008

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

•18-65 years old
•Diagnosed with Schizophrenia or Schizoaffective disorder
•Ability to visit the doctor's office for scheduled visits

Exclusion Criteria

•Women who are pregnant or breastfeeding
•Have a body mass index (BMI) greater than 40
•Have diabetes, heart disease or any other unstable illness
•Have known positive human immunodeficiency virus (HIV)
•Are currently taking olanzapine, risperidone, clozapine, glucocorticoids, injectable antipsychotics

Arms & Interventions

Olanzapine

Intervention: olanzapine

Risperidone

Intervention: risperidone

Outcomes

Primary Outcomes

Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate

Time Frame: baseline and 12 weeks

Normalized insulin sensitivity index (Mffm/I) was defined as the ratio of whole body glucose disposal rate normalized to fat-free mass (Mffm) divided by the plasma insulin concentration (I) during steady-state conditions of the clamp procedure. Units:\[(mg glucose)\*min\*mL\] / \[(kg fat free body mass)\*(micro IU insulin)\]

Secondary Outcomes

Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight.(12 weeks)
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI)(12 weeks)
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Ratio of Visceral Fat Area to the Subcutaneous Fat Area.(12 weeks)
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores.(12 weeks)
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores.(12 weeks)
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores.(12 weeks)
Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores.(12 weeks)
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores.(12 weeks)
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference.(12 weeks)
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area.(12 weeks)
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area.(12 weeks)
Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.(12 weeks)
Change From Baseline to 12 Week Endpoint in Body Mass Index(baseline and 12 weeks)
Change From Baseline to 12 Week Endpoint in Weight(baseline and 12 weeks)
Change From Baseline to 12 Week Endpoint in Waist Circumference(baseline and 12 weeks)
Change From Baseline to 12 Week Endpoint in Visceral Fat Area(baseline and 12 weeks)
Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area(baseline and 12 weeks)
Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area(baseline and 12 weeks)
Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores(baseline and 12 weeks)
Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores(baseline and 12 weeks)
Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores(baseline and 12 weeks)
Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores(baseline and 12 weeks)
Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores(baseline and 12 weeks)
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores(baseline and 12 weeks)
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol(baseline and 12 weeks)
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL)(baseline and 12 weeks)
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL)(baseline and 12 weeks)
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides(baseline and 12 weeks)
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses(baseline and 12 weeks.)