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

Official Title: “Insulin Sensitivity in Patients With Schizophrenia or Schizoaffective Disorder Treated With Olanzapine and Risperidone”

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

Intervention(s) in this Clinical Trial

• Drug: olanzapine
  • 5-20 mg, oral, capsules, daily, 12 weeks.
• Drug: risperidone
  • 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Olanzapine
• Active Comparator: Risperidone

Primary Measures

• 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
    Safety Issue?: Yes

Secondary Measures

• Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI)
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• 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.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Change From Baseline to 12 Week Endpoint in Body Mass Index
  • Time Frame: baseline and 12 weeks
    Safety Issue?: Yes
• Change From Baseline to 12 Week Endpoint in Weight
  • Time Frame: baseline and 12 weeks
    Safety Issue?: Yes
• Change From Baseline to 12 Week Endpoint in Waist Circumference
  • Time Frame: baseline and 12 weeks
    Safety Issue?: Yes
• Change From Baseline to 12 Week Endpoint in Visceral Fat Area
  • Time Frame: baseline and 12 weeks
    Safety Issue?: Yes
• Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area
  • Time Frame: baseline and 12 weeks
    Safety Issue?: Yes
• Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area
  • Time Frame: baseline and 12 weeks
    Safety Issue?: Yes
• Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores
  • Time Frame: baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores
  • Time Frame: baseline and 12 weeks
    Safety Issue?: No
• Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores
  • Time Frame: baseline and 12 weeks
    Safety Issue?: Yes
• Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores
  • Time Frame: baseline and 12 weeks
    Safety Issue?: Yes
• Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores
  • Time Frame: baseline and 12 weeks
    Safety Issue?: Yes
• Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
  • Time Frame: baseline and 12 weeks
    Safety Issue?: Yes
• Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol
  • Time Frame: baseline and 12 weeks
    Safety Issue?: Yes
• Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL)
  • Time Frame: baseline and 12 weeks
    Safety Issue?: Yes
• Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL)
  • Time Frame: baseline and 12 weeks
    Safety Issue?: Yes
• Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides
  • Time Frame: baseline and 12 weeks
    Safety Issue?: Yes
• Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses
  • Time Frame: baseline and 12 weeks.
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Eli Lilly and Company Industry

Overall Clinical Trial Officials and Contacts

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 Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00190749

Study ID Number: 5296

ClinicalTrials.gov Identifier: NCT00190749

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry