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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety Study

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Active Comparator: B

Primary Measures

• Assess if olanzapine and risperidone are associated with a significant within-treatment group change in insulin sensitivity as measured by hyperinsulinemic euglycemic clamp.
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Secondary Measures

• Comparison of effects of olanzapine vs. risperidone on the change in normalized insulin sensitivity index at low insulin phase from baseline to endpoint, after correcting for weight change.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in weight.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in Body Mass Index.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation for each treatment group of the relationships between change 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
• Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in Brief Psychiatric Rating Scale scores.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation for each treatment group of the relationships between change 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
• Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in Abnormal Involuntary Movement Scale scores.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in Barnes Akathisia Scale scores.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in the Simpson Angus Scale scores.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in waist circumference.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in visceral fat area.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in subcutaneous fat area.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation for each treatment group of the relationships between change in normalized insulin sensitivity index at low insulin phase and changes in Eating Behavior Assessment Scale scores.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in Body Mass Index.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in weight.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in waist circumference.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in visceral fat area.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in subcutaneous fat area.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in the ratio of the visceral fat area to the subcutaneous fat area.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in Brief Psychiatric Rating Scale scores.
  • Time Frame: 12 weeks
    Safety Issue?: No
• Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in Clinical Global Impression - Severity of Illness scores.
  • Time Frame: 12 weeks
    Safety Issue?: No
• Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in Abnormal Involuntary Movement Scale scores.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in Barnes Akathisia Scale scores.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in Simpson Angus Scale scores.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation of both the within-treatment group and between-treatment group changes from baseline to endpoint in Eating Behavior Assessment Scale scores.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation of both the within-treatment group and between-treatment group changes in fasting lipid parameters including total cholesterol.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation of both the within-treatment group and between-treatment group changes in fasting lipid parameters including direct LDL.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation of both the within-treatment group and between-treatment group changes in fasting lipid parameters including HDL.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation of both the within-treatment group and between-treatment group changes in fasting lipid parameters including triglycerides.
  • Time Frame: 12 weeks
    Safety Issue?: Yes
• Evaluation of both the within-treatment group and between-treatment group changes in fasting lipid parameters including lipoprotein subclasses.
  • Time Frame: 12 weeks.
    Safety Issue?: Yes

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

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 Sponsor: Eli Lilly and Company

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 November 19, 2008

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