Skip to main content
OpenTrials
Completed

NCT Number: NCT00190749

Safety Study of Olanzapine and a Comparator in Patients With Schizophrenia and Schizoaffective Disorder

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine

Drug

5-20 mg, oral, capsules, daily, 12 weeks.

Other names: LY170053, Zyprexa

Risperidone

Drug

2-6 mg, oral, capsules, twice daily (BID), 12 weeks.

Primary outcomes

  1. Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate

    Time frame: 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 outcomes

  1. Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight.

    Time frame: 12 weeks

    Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in weight

  2. Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI)

    Time frame: 12 weeks

    Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in BMI

  3. 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.

    Time frame: 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

  4. Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores.

    Time frame: 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

  5. Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores.

    Time frame: 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

  6. Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores.

    Time frame: 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

  7. Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores.

    Time frame: 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

  8. Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores.

    Time frame: 12 weeks

    Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in the Simpson Angus Scale scores

  9. Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference.

    Time frame: 12 weeks

    Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in waist circumference

  10. Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area.

    Time frame: 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

  11. Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area.

    Time frame: 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

  12. Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.

    Time frame: 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

  13. Change From Baseline to 12 Week Endpoint in Body Mass Index

    Time frame: baseline and 12 weeks

    Within-and Between-Treatment Group changes in Body Mass Index from baseline to last observation carried forward.

  14. Change From Baseline to 12 Week Endpoint in Weight

    Time frame: baseline and 12 weeks

    Weight change from baseline to last visit (last observation carried forward)

  15. Change From Baseline to 12 Week Endpoint in Waist Circumference

    Time frame: baseline and 12 weeks

    Waist circumference change from baseline to last observation carried forward.

  16. Change From Baseline to 12 Week Endpoint in Visceral Fat Area

    Time frame: baseline and 12 weeks

    Visceral fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period

  17. Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area

    Time frame: baseline and 12 weeks

    Subcutaneous fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period

  18. Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area

    Time frame: 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

  19. Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores

    Time frame: 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.

  20. Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores

    Time frame: 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.

  21. Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores

    Time frame: 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.

  22. Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores

    Time frame: 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.

  23. Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores

    Time frame: 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.

  24. Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores

    Time frame: 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).

  25. Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol

    Time frame: baseline and 12 weeks

    Fasting lipid parameters including total cholesterol, change from baseline to last observation carried forward.

  26. Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL)

    Time frame: baseline and 12 weeks

    Fasting lipid parameters including Direct LDL, change from baseline to last observation carried forward.

  27. Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL)

    Time frame: baseline and 12 weeks

    Fasting lipid parameters including HDL change from baseline to last observation carried forward.

  28. Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides

    Time frame: baseline and 12 weeks

    Changes in fasting lipid parameters including triglycerides last observation carried forward (LOCF) mean change from baseline

  29. Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Insulin Sensitivity in Patients With Schizophrenia or Schizoaffective Disorder Treated With Olanzapine and Risperidone

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Sep 19, 2005
Registry last updated
May 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.