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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

Page last updated: August 23, 2015

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