Safety Study of Olanzapine and a Comparator in Patients With Schizophrenia and Schizoaffective Disorder
Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizoaffective Disorder
Intervention: olanzapine (Drug); risperidone (Drug)
Phase: Phase 4
Status: Completed
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
Summary
This study will assess whether olanzapine and/or risperidone affect the way the human body
uses sugar in the blood.
Clinical Details
Official title: Insulin Sensitivity in Patients With Schizophrenia or Schizoaffective Disorder Treated With Olanzapine and Risperidone
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate
Secondary outcome: Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight.Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI) 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. Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores. Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores. Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores. Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores. Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores. Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference. Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area. Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area. Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. Change From Baseline to 12 Week Endpoint in Body Mass Index Change From Baseline to 12 Week Endpoint in Weight Change From Baseline to 12 Week Endpoint in Waist Circumference Change From Baseline to 12 Week Endpoint in Visceral Fat Area Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL) Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL) Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses
Eligibility
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 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
Locations and Contacts
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 92161, United States
Additional Information
Lilly Clinical Trial Registry
Starting date: October 2003
Last updated: April 26, 2010
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