Safety Study of Olanzapine and a Comparator in Patients With Schizophrenia and Schizoaffective Disorder

Condition(s) targeted: Schizophrenia; Schizoaffective Disorder

Intervention: olanzapine (Drug); risperidone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

Overall contact:
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559

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

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety Study

Primary outcome:

Assess if olanzapine and risperidone are associated with a significant within-treatment group change in insulin sensitivity over 12-week period as measured by rinsulinemic euglycemic clamp

For the primary and key secondary analyses, insulin sensitivity will be measured by the insulin sensitivity index ([mean glucose infusion rate/fat free mass]/mean insulin concentration)determined

at steady state during the low insulin infusion phase of a two-step hyperinsulinemic euglycemic clamp

Secondary outcome:

Comparison of effects of olanzapine vs. risperidone on the change in insulin sensitivity index from baseline to endpoint

Evaluation for each treatment group of the relationships between change in insulin sensitivity index and changes in

weight, BMI, waist circumference, visceral fat area, subcutaneous fat area, ratio of visceral fat area to subcutaneous fat area

Evaluation for each treatment group of the relationship between change in insulin sensitivity index and changes in

BPRS, CGI-S, AIMS, Barnes Akathisia, Simpson-Angus Scale and Eating Behavior Assessment Scale

Evaluation of within-treatment group and between-treatment groups changes in: BMI, weight, waist circumference, visceral fat area,

subcutaneous fat area, ratio of visceral fat area to subcutaneous fat area,

BPRS, CGI-S, AIMS, BAS, Simpson-Angus Scale, Eating Behavior Assessment Scale for olanzapine and risperidone

Evaluate the within-treatment group and between-treatment group changes in fasting lipid parameters for olanzapine and risperidone

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 18-65 years old

- Diagnosed with Schizophrenia or Schizoaffective disorder

- Ability to visit the Dr's office for scheduled visits

Exclusion Criteria:

- Women who are pregnant or breastfeeding

- Have a BMI greater than 40

- Have diabetes, heart disease or any other unstable illness

- Have known positive HIV

- Are currently taking olanzapine, risperidone, clozapine, glucocorticoids, injectable

antipsychotics

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, Phone: 1-317-615-4559

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., National City, California 91950, United States; Recruiting
Eli Lilly

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., San Diego, California 92123, United States; Recruiting
Eli Lilly

Lilly Clinical Trial Registry

Starting date: October 2003
Ending date: May 2008
Last updated: January 21, 2008