Clinical trial NCT00190749: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight.
timeFrame: 12 weeks
measure: Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI)
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
measure: Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores.
timeFrame: 12 weeks
measure: Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores.
timeFrame: 12 weeks
measure: Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores.
timeFrame: 12 weeks
measure: Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores.
timeFrame: 12 weeks
measure: Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores.
timeFrame: 12 weeks
measure: Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference.
timeFrame: 12 weeks
measure: Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area.
timeFrame: 12 weeks
measure: Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area.
timeFrame: 12 weeks
measure: Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.
timeFrame: 12 weeks
measure: Change From Baseline to 12 Week Endpoint in Body Mass Index
timeFrame: baseline and 12 weeks
measure: Change From Baseline to 12 Week Endpoint in Weight
timeFrame: baseline and 12 weeks
measure: Change From Baseline to 12 Week Endpoint in Waist Circumference
timeFrame: baseline and 12 weeks
measure: Change From Baseline to 12 Week Endpoint in Visceral Fat Area
timeFrame: baseline and 12 weeks
measure: Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area
timeFrame: baseline and 12 weeks
measure: Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area
timeFrame: baseline and 12 weeks
measure: Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores
timeFrame: baseline and 12 weeks
measure: Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores
timeFrame: baseline and 12 weeks
measure: Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores
timeFrame: baseline and 12 weeks
measure: Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores
timeFrame: baseline and 12 weeks
measure: Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores
timeFrame: baseline and 12 weeks
measure: Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
timeFrame: baseline and 12 weeks
measure: Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol
timeFrame: baseline and 12 weeks
measure: Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL)
timeFrame: baseline and 12 weeks
measure: Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL)
timeFrame: baseline and 12 weeks
measure: Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides
timeFrame: baseline and 12 weeks
measure: Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses
timeFrame: baseline and 12 weeks.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: 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.
state: California
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Case M, Treuer T, Karagianis J, Hoffmann VP. The potential role of appetite in predicting weight changes during treatment with olanzapine. BMC Psychiatry. 2010 Sep 14;10:72. doi: 10.1186/1471-244X-10-72.