Safety Study of Olanzapine and a Comparator in Patients With Schizophrenia and Schizoaffective Disorder
- Conditions
- SchizophreniaSchizoaffective Disorder
- Interventions
- Registration Number
- NCT00190749
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This study will assess whether olanzapine and/or risperidone affect the way the human body uses sugar in the blood.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- 18-65 years old
- Diagnosed with Schizophrenia or Schizoaffective disorder
- Ability to visit the doctor's office for scheduled visits
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Olanzapine olanzapine - Risperidone risperidone -
- Primary Outcome Measures
Name Time Method Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate baseline and 12 weeks Normalized insulin sensitivity index (Mffm/I) was defined as the ratio of whole body glucose disposal rate normalized to fat-free mass (Mffm) divided by the plasma insulin concentration (I) during steady-state conditions of the clamp procedure. Units:\[(mg glucose)\*min\*mL\] / \[(kg fat free body mass)\*(micro IU insulin)\]
- Secondary Outcome Measures
Name Time Method Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight. 12 weeks Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in weight
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI) 12 weeks Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in 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. 12 weeks Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in ratio of visceral far area to subcutaneous fat area
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores. 12 weeks Normalized insulin senstivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I 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. 12 weeks Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I 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. 12 weeks Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I 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. 12 weeks Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Barnes Akathisia scores
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores. 12 weeks Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between 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. 12 weeks Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in waist circumference
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area. 12 weeks Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I 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. 12 weeks Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I 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. 12 weeks Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in Eating Behavior Assessment Scale scores
Change From Baseline to 12 Week Endpoint in Body Mass Index baseline and 12 weeks Within-and Between-Treatment Group changes in Body Mass Index from baseline to last observation carried forward.
Change From Baseline to 12 Week Endpoint in Weight baseline and 12 weeks Weight change from baseline to last visit (last observation carried forward)
Change From Baseline to 12 Week Endpoint in Waist Circumference baseline and 12 weeks Waist circumference change from baseline to last observation carried forward.
Change From Baseline to 12 Week Endpoint in Visceral Fat Area baseline and 12 weeks Visceral fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period
Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area baseline and 12 weeks Subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period
Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area baseline and 12 weeks Ratio of the visceral fat area to the subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period
Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores baseline and 12 weeks Brief Psychiatric Rating Scale (BPRS) is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Item scores range from 0 (not present) to 6 (extremely severe). Total Scores range from 0 to 108; Positive Subscale Scores range from 0 to 24. Negative Subscale Scores range from 0 to 18. Anxiety-Depression Subscale Scores range from 0 to 24.
Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores baseline and 12 weeks Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.
Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores baseline and 12 weeks A 12-item instrument assesses observed abnormal movements in different parts of body. Seven items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in 3 main anatomic areas (orofacial area, extremities, and trunk). Total scores range from 0 to 28. Five collected elements are not used in this total.
Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores baseline and 12 weeks The BARS is a 4-item instrument that evaluates akathisia associated with use of antipsychotic medications. Item 4 is the Global clinical assessment and is rated 0 to 5 (0 = absent, 5 = severe). The other 3 items (related to objective and subjective assessments) are not used for these analyses.
Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores baseline and 12 weeks Measures neuroleptic-induced parkinsonism. Total score of Simpson Angus Scale consists of the sum of 10 items rated on a 5-point severity scale where 0=normal and 4=extreme. The total score ranges from 0 to 40.
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores baseline and 12 weeks Eating Behavior Assessment Scale is a 9-item self-rated tool used to evaluate appetite and eating behaviors. Item scores range from 0 (never) to 4 (always).
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol baseline and 12 weeks Fasting lipid parameters including total cholesterol, change from baseline to last observation carried forward.
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL) baseline and 12 weeks Fasting lipid parameters including Direct LDL, change from baseline to last observation carried forward.
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL) baseline and 12 weeks Fasting lipid parameters including HDL change from baseline to last observation carried forward.
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides baseline and 12 weeks Changes in fasting lipid parameters including triglycerides last observation carried forward (LOCF) mean change from baseline
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses baseline and 12 weeks. Changes in lipid parameters and subclass lipoproteins last observation carried forward (LOCF) mean change from baseline. HDL=High Density Lipoprotein, IDL=Intermdiate Density Lipoprotein, LDL=Low Density Lipoprotein, VLDL=Very Low Density Lipoprotein.
Trial Locations
- Locations (1)
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, United States