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CompletedNCT00190749Updated May 4, 2010Results posted

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

A Phase 4 interventional study of olanzapine and risperidone in Schizophrenia and Schizoaffective Disorder, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-05-04.

Sponsored by Eli Lilly and Company · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Schizophrenia
  • Schizoaffective Disorder
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 130 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18-65 years old
  • Diagnosed with Schizophrenia or Schizoaffective disorder
  • Ability to visit the doctor's office for scheduled visits

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    Olanzapine

    Drug: olanzapine

  • Active comparator
    Risperidone

    Drug: risperidone

Interventions

  • Drugolanzapine

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

    Also known as: LY170053, Zyprexa

  • Drugrisperidone

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

06

What researchers measure

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

    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:\[(mg glucose)\*min\*mL\] / \[(kg fat free body mass)\*(micro IU insulin)\]

    Time frame: baseline and 12 weeks

Secondary outcomes

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

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

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

  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.

    Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in ratio of visceral far area to subcutaneous fat area

    Time frame: 12 weeks

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

    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

    Time frame: 12 weeks

  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.

    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

    Time frame: 12 weeks

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

    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

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

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

    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

    Time frame: 12 weeks

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

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

    Time frame: baseline and 12 weeks

  14. Change From Baseline to 12 Week Endpoint in Weight

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

    Time frame: baseline and 12 weeks

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

    Waist circumference change from baseline to last observation carried forward.

    Time frame: baseline and 12 weeks

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

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

    Time frame: baseline and 12 weeks

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

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

    Time frame: baseline and 12 weeks

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

    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

    Time frame: baseline and 12 weeks

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

    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.

    Time frame: baseline and 12 weeks

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

    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.

    Time frame: baseline and 12 weeks

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

    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.

    Time frame: baseline and 12 weeks

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

    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.

    Time frame: baseline and 12 weeks

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

    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.

    Time frame: baseline and 12 weeks

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

    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).

    Time frame: baseline and 12 weeks

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

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

    Time frame: baseline and 12 weeks

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

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

    Time frame: baseline and 12 weeks

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

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

    Time frame: baseline and 12 weeks

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

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

    Time frame: baseline and 12 weeks

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

    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.

    Time frame: baseline and 12 weeks.

07

Results

Posted Jul 23, 2009

Participant flow

Participant flow — Overall Study
MilestoneOlanzapineRisperidone
Started6862
Completed4231
Not completed2631
Withdrew: Lost to follow-up811
Withdrew: Withdrawal by subject106
Withdrew: Protocol violation54
Withdrew: Adverse event05
Withdrew: Lack of efficacy23
Withdrew: Reason not specified02
Withdrew: Sponsor decision10

Outcome measures

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

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:\[(mg glucose)\*min\*mL\] / \[(kg fat free body mass)\*(micro IU insulin)\]

Time frame:
baseline and 12 weeks
Reported as:
Mean · Mffm/I
Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate
Mffm/IOlanzapineRisperidone
Baseline0.1664 ± 0.11200.1937 ± 0.1286
Change to Last Observation-0.0149 ± 0.0786-0.0327 ± 0.0829
Statistical analysis
  • Olanzapine · t-test, 2 sided · p = 0.226 (P-value for change to last observation)
  • Risperidone · t-test, 2 sided · p = 0.030 (P-value is change to last observation)
  • Olanzapine vs Risperidone · ANCOVA · p = 0.204 (P-value for change to last observation.)
SecondaryPairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight.

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

Time frame:
12 weeks
Reported as:
Number · correlation
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight.
correlationOlanzapineRisperidone
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight.-0.212-0.188
Statistical analysis
  • Olanzapine · Pearson's correlation coefficient · p = 0.184
  • Risperidone · Pearson's correlation coefficient · p = 0.295
SecondaryPairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI)

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

Time frame:
12 weeks
Reported as:
Number · correlation
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI)
correlationOlanzapineRisperidone
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI)-0.182-0.195
Statistical analysis
  • Olanzapine · Pearson's correlation coefficient · p = 0.256
  • Risperidone · Pearson's correlation coefficient · p = 0.277
SecondaryPairwise 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.

Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in ratio of visceral far area to subcutaneous fat area

Time frame:
12 weeks
Reported as:
Number · correlation
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.
correlationOlanzapineRisperidone
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.-0.0550.101
Statistical analysis
  • Olanzapine · Pearson's correlation coefficient · p = 0.766
  • Risperidone · Pearson's correlation coefficient · p = 0.622
SecondaryPairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores.

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

Time frame:
12 weeks
Reported as:
Number · correlation
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores.
correlationOlanzapineRisperidone
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores.0.0350.066
Statistical analysis
  • Olanzapine · Pearson's correlation coefficient · p = 0.829
  • Risperidone · Pearson's correlation coefficient · p = 0.714
SecondaryPairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores.

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

Time frame:
12 weeks
Reported as:
Number · correlation
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores.
correlationOlanzapineRisperidone
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores.0.0680.234
Statistical analysis
  • Olanzapine · Pearson's correlation coefficient · p = 0.672
  • Risperidone · Pearson's correlation coefficient · p = 0.191
SecondaryPairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores.

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

Time frame:
12 weeks
Reported as:
Number · correlation
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores.
correlationOlanzapineRisperidone
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores.0.001-0.134
Statistical analysis
  • Olanzapine · Pearson's correlation coefficient · p = 0.994
  • Risperidone · Pearson's correlation coefficient · p = 0.456
SecondaryPairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores.

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

Time frame:
12 weeks
Reported as:
Number · correlation
Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores.
correlationOlanzapineRisperidone
Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores.-0.1200.006
Statistical analysis
  • Olanzapine · Pearson's correlation coefficient · p = 0.454
  • Risperidone · Pearson's correlation coefficient · p = 0.974
SecondaryPairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores.

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

Time frame:
12 weeks
Reported as:
Number · correlation
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores.
correlationOlanzapineRisperidone
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores.0.1840.249
Statistical analysis
  • Olanzapine · Pearson's correlation coefficient · p = 0.249
  • Risperidone · Pearson's correlation coefficient · p = 0.163
SecondaryPairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference.

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

Time frame:
12 weeks
Reported as:
Number · correlation
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference.
correlationOlanzapineRisperidone
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference.-0.206-0.263
Statistical analysis
  • Olanzapine · Pearson's correlation coefficient · p = 0.201
  • Risperidone · Pearson's correlation coefficient · p = 0.168
SecondaryPairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area.

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

Time frame:
12 weeks
Reported as:
Number · correlation
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area.
correlationOlanzapineRisperidone
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area.-0.048-0.057
Statistical analysis
  • Olanzapine · Pearson's correlation coefficient · p = 0.793
  • Risperidone · Pearson's correlation coefficient · p = 0.777
SecondaryPairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area.

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

Time frame:
12 weeks
Reported as:
Number · correlation
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area.
correlationOlanzapineRisperidone
Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area.-0.043-0.085
Statistical analysis
  • Olanzapine · Pearson's correlation coefficient · p = 0.815
  • Risperidone · Pearson's correlation coefficient · p = 0.675
SecondaryPairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.

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

Time frame:
12 weeks
Reported as:
Number · correlation
Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores.
correlationOlanzapineRisperidone
Item 1: How Hungry?-0.137-0.371
Item 2: How Strong Appetite?-0.137-0.269
Item 3: Craved Sweets or Other Carbohydrates?-0.0090.035
Item 4: Craved Fatty Foods?-0.068-0.184
Item 5: Felt Full or Satisfied After Meal?-0.117-0.060
Item 6:Excessive Amount of Food to Feel Satisfied?0.1340.067
Item 7: Thinking About Food?-0.1720.045
Item 8: Overeating?-0.032-0.165
Item 9: Feel Eating is Out of Control?-0.075-0.354
Statistical analysis
  • Olanzapine · Pearson's correlation coefficient · p = 0.393
  • Risperidone · Pearson's correlation coefficient · p = 0.033
  • Olanzapine · Pearson's correlation coefficient · p = 0.392
  • Risperidone · Pearson's correlation coefficient · p = 0.129
  • Olanzapine · Pearson's correlation coefficient · p = 0.956
  • Risperidone · Pearson's correlation coefficient · p = 0.846
  • Olanzapine · Pearson's correlation coefficient · p = 0.675
  • Risperidone · Pearson's correlation coefficient · p = 0.306
  • Olanzapine · Pearson's correlation coefficient · p = 0.468
  • Risperidone · Pearson's correlation coefficient · p = 0.739
  • Olanzapine · Pearson's correlation coefficient · p = 0.404
  • Risperidone · Pearson's correlation coefficient · p = 0.711
  • Olanzapine · Pearson's correlation coefficient · p = 0.281
  • Risperidone · Pearson's correlation coefficient · p = 0.805
  • Olanzapine · Pearson's correlation coefficient · p = 0.844
  • Risperidone · Pearson's correlation coefficient · p = 0.359
  • Olanzapine · Pearson's correlation coefficient · p = 0.642
  • Risperidone · Pearson's correlation coefficient · p = 0.043
SecondaryChange From Baseline to 12 Week Endpoint in Body Mass Index

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

Time frame:
baseline and 12 weeks
Reported as:
Mean · kilograms per square meter (kg/m2)
Change From Baseline to 12 Week Endpoint in Body Mass Index
kilograms per square meter (kg/m2)OlanzapineRisperidone
Baseline28.96 ± 5.1728.79 ± 5.40
Change to Last Observation1.02 ± 1.610.39 ± 1.15
Statistical analysis
  • Olanzapine · t-test, 2 sided · p = <.001Within group p-values are from t-tests on Least Squares Mean (LSMean) change
  • Risperidone · t-test, 2 sided · p = 0.019Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.065Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator
SecondaryChange From Baseline to 12 Week Endpoint in Weight

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

Time frame:
baseline and 12 weeks
Reported as:
Mean · kilograms
Change From Baseline to 12 Week Endpoint in Weight
kilogramsOlanzapineRisperidone
Baseline85.93 ± 17.2686.55 ± 19.53
Change to Last Observation2.98 ± 4.821.23 ± 4.45
Statistical analysis
  • Olanzapine · t-test, 2 sided · p = <.001With group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.013Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.076Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change = Baseline Treatment Pooled Investigator
SecondaryChange From Baseline to 12 Week Endpoint in Waist Circumference

Waist circumference change from baseline to last observation carried forward.

Time frame:
baseline and 12 weeks
Reported as:
Mean · centimeters
Change From Baseline to 12 Week Endpoint in Waist Circumference
centimetersOlanzapineRisperidone
Baseline99.13 ± 14.4298.49 ± 11.60
Change to Last Observation2.38 ± 7.460.17 ± 4.99
Statistical analysis
  • Olanzapine · t-test, 2 sided · p = 0.007Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.266Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.239Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change = Baseline Treatment Pooled Investigator
SecondaryChange From Baseline to 12 Week Endpoint in Visceral Fat Area

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

Time frame:
baseline and 12 weeks
Reported as:
Mean · square centimeters (cm2)
Change From Baseline to 12 Week Endpoint in Visceral Fat Area
square centimeters (cm2)OlanzapineRisperidone
Baseline101.46 ± 54.99102.17 ± 52.61
Change to Last Observation4.70 ± 21.218.70 ± 42.39
Statistical analysis
  • Olanzapine · t-test, 2 sided · p = 0.274Within group p-vales are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.105Within group p-values are from t-tests on LSMean change.
  • Olanzapine vs Risperidone · ANCOVA · p = 0.609Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change= Baseline Treatment Pooled Investigator
SecondaryChange From Baseline to 12 Week Endpoint in Subcutaneous Fat Area

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

Time frame:
baseline and 12 weeks
Reported as:
Mean · square centimeters (cm2)
Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area
square centimeters (cm2)OlanzapineRisperidone
Baseline281.07 ± 158.59317.16 ± 172.19
Change to last observation4.94 ± 40.3635.15 ± 105.64
Statistical analysis
  • Olanzapine · t-test, 2 sided · p = 0.406With group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.011Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.076Overall group p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
SecondaryChange From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area

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

Time frame:
baseline and 12 weeks
Reported as:
Mean · ratio in square centimeters (cm2)
Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area
ratio in square centimeters (cm2)OlanzapineRisperidone
Baseline0.41 ± 0.250.43 ± 0.33
Change to last observation0.01 ± 0.120.00 ± 0.14
Statistical analysis
  • Olanzapine · t-test, 2 sided · p = 0.456Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.712Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.689Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change= Baseline Treatment Pooled Investigator
SecondaryChange From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores

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.

Time frame:
baseline and 12 weeks
Reported as:
Mean · units on a scale
Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores
units on a scaleOlanzapineRisperidone
Total Score Baseline13.32 ± 6.2613.96 ± 6.02
Total Score Change to Last Observation-1.98 ± 6.30-1.48 ± 7.99
Positive Subscale Score Baseline5.22 ± 2.755.27 ± 2.51
Positive Subscale Score Change to Last Observation-0.82 ± 2.81-1.20 ± 3.08
Negative Subscale Score Baseline2.32 ± 2.041.88 ± 1.83
Negative Subscale Score Change to Last Observation-0.38 ± 1.58-0.02 ± 1.99
Anxiety-Depression Baseline4.33 ± 2.593.73 ± 2.18
Anxiety-Depression Change to Last Observation-0.78 ± 2.29-0.32 ± 2.50
Statistical analysis
  • Olanzapine · t-test, 2 sided · p = 0.111Within group p-values are from t-tests on LSMean
  • Risperidone · t-test, 2 sided · p = 0.159Within group p-values are from t-tests on LSMean changes
  • Olanzapine vs Risperidone · ANCOVA · p = 0.951Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator
  • Olanzapine · t-test, 2 sided · p = 0.012Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.002With group p-values are from t-tests on LSMean
  • Olanzapine vs Risperidone · ANCOVA · p = 0.467Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change =Baseline Treatment Pooled Investigator
  • Olanzapine · t-test, 2 sided · p = 0.365With group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.846Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.559Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
  • Olanzapine · t-test, 2 sided · p = 0.150Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.612Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.475Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
SecondaryChange From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores

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.

Time frame:
baseline and 12 weeks
Reported as:
Mean · units on a scale
Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores
units on a scaleOlanzapineRisperidone
Baseline3.65 ± 0.553.61 ± 0.53
Change to last observation-0.22 ± 0.58-0.23 ± 0.66
Statistical analysis
  • Olanzapine · t-test, 2 sided · p = .012 (Within group p-values are from t-tests on LSMean change)
  • Risperidone · t-test, 2 sided · p = 0.010Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.760Overall p-values are from Type 3 sums of square ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
SecondaryChange From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores

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.

Time frame:
baseline and 12 weeks
Reported as:
Mean · units on a scale
Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores
units on a scaleOlanzapineRisperidone
Baseline0.48 ± 1.240.53 ± 1.25
Change to last observation0.04 ± 1.150.04 ± 1.35
Statistical analysis
  • Olanzapine · t-test, 2 sided · p = 0.943Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.763Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.832Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
SecondaryChange From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores

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.

Time frame:
baseline and 12 weeks
Reported as:
Mean · units on a scale
Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores
units on a scaleOlanzapineRisperidone
Baseline0.24 ± 0.640.36 ± 0.70
Change to last observation0.02 ± 0.84-0.02 ± 0.82
Statistical analysis
  • Olanzapine · t-test, 2 sided · p = 0.623Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.853Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.591Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
SecondaryChange From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores

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.

Time frame:
baseline and 12 weeks
Reported as:
Mean · units on a scale
Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores
units on a scaleOlanzapineRisperidone
Baseline1.13 ± 2.020.94 ± 1.79
Change to last observation-0.06 ± 1.480.30 ± 1.92
Statistical analysis
  • Olanzapine · t-test, 2 sided · p = 0.302Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.922Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.479Overall group p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
SecondaryChange From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores

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).

Time frame:
baseline and 12 weeks
Reported as:
Mean · units on a scale
Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores
units on a scaleOlanzapineRisperidone
Item 1 Baseline (How Hungry?)1.42 ± 1.091.32 ± 0.94
Item 1 Change to Last Observation0.25 ± 1.270.42 ± 1.18
Item 2 Baseline (How Strong Appetite?)1.54 ± 1.101.32 ± 1.03
Item 2 Change to Last Observation0.17 ± 1.260.38 ± 1.33
Item 3 Baseline (Craved Sweets or Other Carbos?)1.00 ± 1.170.83 ± 1.10
Item 3 Change to Last Observation0.19 ± 1.470.36 ± 1.18
Item 4 Baseline (Craved Fatty Foods?)0.80 ± 1.010.74 ± 1.00
Item 4 Change to Last Observation0.31 ± 1.520.25 ± 1.05
Item 5 Baseline (Felt Full After Meal?)2.59 ± 0.932.55 ± 0.89
Item 5 Change to Last Observation-0.17 ± 1.150.00 ± 1.19
Item 6 Baseline(Excessive Food to Feel Satisfied?)0.86 ± 1.210.79 ± 1.12
Item 6 Change to Last Observation0.17 ± 1.400.28 ± 1.25
Item 7 Baseline (Thinking About Food?)0.90 ± 1.180.77 ± 1.14
Item 7 Change to Last Observation0.12 ± 1.310.13 ± 1.36
Item 8 Baseline (Overeating?)0.42 ± 0.950.53 ± 1.08
Item 8 Change to Last Observation0.17 ± 1.330.15 ± 1.31
Item 9 Baseline (Feel Eating is Out of Control?)0.10 ± 0.360.26 ± 0.76
Item 9 Change to Last Observation0.25 ± 0.940.11 ± 1.01
Statistical analysis
  • Olanzapine · t-test, 2 sided · p = 0.004Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.001Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.549Overall p-values are from Type 3 sums of squares, ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
  • Olanzapine · t-test, 2 sided · p = 0.011Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.009Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.793Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
  • Olanzapine · t-test, 2 sided · p = 0.045Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.027Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.699Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
  • Olanzapine · t-test, 2 sided · p = 0.002Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.019Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.733Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
  • Olanzapine · t-test, 2 sided · p = 0.034Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.235Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.532Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
  • Olanzapine · t-test, 2 sided · p = 0.242Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.186Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.799Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
  • Olanzapine · t-test, 2 sided · p = 0.097Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.214Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.827Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
  • Olanzapine · t-test, 2 sided · p = 0.151Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.071Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.629Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
  • Olanzapine · t-test, 2 sided · p = 0.036Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.112Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.806Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
SecondaryChange From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol

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

Time frame:
baseline and 12 weeks
Reported as:
Mean · millimoles per Liter (mmol/L)
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol
millimoles per Liter (mmol/L)OlanzapineRisperidone
Baseline4.91 ± 1.064.97 ± 1.12
Change to Last Observation0.18 ± 0.890.01 ± 0.79
Statistical analysis
  • Olanzapine · t-test, 2 sided · p = 0.156Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.829Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.352Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
SecondaryChange From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL)

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

Time frame:
baseline and 12 weeks
Reported as:
Mean · millimoles per Liter (mmol/L)
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL)
millimoles per Liter (mmol/L)OlanzapineRisperidone
Baseline3.18 ± 0.903.11 ± 0.99
Change to last observation-0.03 ± 0.67-0.02 ± 0.63
Statistical analysis
  • Olanzapine · t-test, 2 sided · p = 0.740Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.760Within group p-values are frm t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.997Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
SecondaryChange From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL)

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

Time frame:
baseline and 12 weeks
Reported as:
Mean · millimoles per Liter (mmol/L)
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL)
millimoles per Liter (mmol/L)OlanzapineRisperidone
Baseline1.08 ± 0.251.18 ± 0.32
Change to last observation0.06 ± 0.240.05 ± 0.27
Statistical analysis
  • Olanzapine · t-test, 2 sided · p = 0.176Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.237Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.996Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
SecondaryChange From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides

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

Time frame:
baseline and 12 weeks
Reported as:
Mean · millimoles per Liter (mmol/L)
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides
millimoles per Liter (mmol/L)OlanzapineRisperidone
Baseline1.68 ± 0.911.55 ± 0.85
Change to Last Observation0.34 ± 1.12-0.10 ± 0.74
Statistical analysis
  • Olanzapine · t-test, 2 sided · p = 0.027Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.545Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.024Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
SecondaryChange From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses

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.

Time frame:
baseline and 12 weeks.
Reported as:
Mean · nanomoles per Liter (nmol/L)
Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses
nanomoles per Liter (nmol/L)OlanzapineRisperidone
HDL particles, total, baseline28.39 ± 5.3829.81 ± 5.29
HDL particles, total, change to last observation1.71 ± 4.84-1.09 ± 4.34
IDL, baseline53.18 ± 55.3252.56 ± 61.38
IDL, change to last observation21.40 ± 59.63-2.69 ± 46.07
Medium small LDL, baseline175.15 ± 98.59197.00 ± 116.28
Medium small LDL, change to last observation35.70 ± 52.40-11.47 ± 84.73
Small LDL, baseline878.68 ± 481.65977.84 ± 622.99
Small LDL, change to last observation128.55 ± 236.89-74.09 ± 428.13
Very small LDL, baseline703.63 ± 385.31780.78 ± 508.24
Very small LDL, change to last observation92.75 ± 193.00-62.50 ± 347.08
VLDL mean particle size, baseline51.21 ± 8.5751.05 ± 11.83
VLDL mean particle size, change to last observ.4.09 ± 7.831.80 ± 9.21
Statistical analysis
  • Olanzapine · t-test, 2 sided · p = 0.009Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.959Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.038 (Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline TReatment Pooled Investigator)
  • Olanzapine · t-test, 2 sided · p = 0.013Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.928Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.049Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
  • Olanzapine · t-test, 2 sided · p = 0.009Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.662Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.12Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
  • Olanzapine · t-test, 2 sided · p = 0.099Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.304Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.024Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator
  • Olanzapine · t-test, 2 sided · p = 0.176Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.246Withn group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.033 (Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator)
  • Olanzapine · t-test, 2 sided · p = <0.001Within group p-values are from t-tests on LSMean change
  • Risperidone · t-test, 2 sided · p = 0.047Within group p-values are from t-tests on LSMean change
  • Olanzapine vs Risperidone · ANCOVA · p = 0.221Overall p-values are from Type 3 sums of squares ANCOVA, Model: Change=Baseline Treatment Pooled Investigator

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Olanzapine—2/68 (2.9%)42/68 (61.8%)
Risperidone—5/62 (8.1%)43/62 (69.4%)
Most frequent serious events
Most frequent serious events
EventOlanzapineRisperidone
AsthmaImmune system disorders0/681/62
Psychotic disorderPsychiatric disorders0/681/62
Schizoaffective disorderPsychiatric disorders1/681/62
Suicidal ideationPsychiatric disorders0/681/62
HypotensionVascular disorders0/681/62
SchizophreniaPsychiatric disorders1/680/62
Most frequent other events
Most frequent other events
EventOlanzapineRisperidone
Weight increasedInvestigations11/684/62
HeadacheNervous system disorders7/688/62
Increased appetiteMetabolism and nutrition disorders5/687/62
InsomniaPsychiatric disorders4/687/62
SedationNervous system disorders7/684/62
AnxietyPsychiatric disorders1/686/62
Dry mouthGastrointestinal disorders5/685/62
DiscomfortGeneral disorders5/682/62
DiarrhoeaGastrointestinal disorders4/681/62

Baseline characteristics

Age Continuous
Age Continuous(years)OlanzapineRisperidoneTotal
Mean43.49 ± 9.4542.58 ± 8.9843.06 ± 9.20
Sex: Female, Male
Sex: Female, Male(Participants)OlanzapineRisperidoneTotal
Female232144
Male454186
Region of Enrollment
Region of Enrollment(participants)OlanzapineRisperidoneTotal
United States6862130
Diagnosis
Diagnosis(participants)OlanzapineRisperidoneTotal
Schizophrenia,paranoid404585
Schizoaffective disorder271643
Schizophrenia, undifferentiated112
Race/Ethnicity
Race/Ethnicity(participants)OlanzapineRisperidoneTotal
Caucasian273057
African descent342660
Hispanic459
East Asian101
Other213
Brief Psychiatric Rating Scale Anxiety Depression Score-Baseline
Brief Psychiatric Rating Scale Anxiety Depression Score-Baseline(units on a scale)OlanzapineRisperidoneTotal
Mean4.46 ± 2.463.74 ± 2.134.12 ± 2.33
Brief Psychiatric Rating Scale Negative Symptom Score-Baseline
Brief Psychiatric Rating Scale Negative Symptom Score-Baseline(units on a scale)OlanzapineRisperidoneTotal
Mean2.28 ± 1.981.89 ± 1.792.09 ± 1.89
Brief Psychiatric Rating Scale Positive Symptom Score-Baseline
Brief Psychiatric Rating Scale Positive Symptom Score-Baseline(units on a scale)OlanzapineRisperidoneTotal
Mean5.40 ± 2.695.47 ± 2.525.43 ± 2.60

5 further baseline measures are reported on the registry.

08

Study locations

1 site
  • 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
09

References and documents

Publications

  • 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. PubMed 20840778 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00190749
Lead sponsor
Eli Lilly and Company
First posted
Sep 19, 2005
Start date
Oct 2003
Primary completion
Jun 2008
Completion
Jun 2008
Results posted
Jul 23, 2009
Last update
May 4, 2010

Study contacts

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 · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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