Schizoaffective Disorder, Schizophrenia
Conditions
Brief summary
This study will assess whether olanzapine and/or risperidone affect the way the human body uses sugar in the blood.
Interventions
DRUGolanzapine
5-20 mg, oral, capsules, daily, 12 weeks.
DRUGrisperidone
2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 |
| 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. |
| 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 |
Countries
United States
Participant flow
Pre-assignment details
Study Period I was a Screening Period. Study Period II was a Inpatient Washout/Diet Stabilization Period. Study Period III (randomization) was the Double-Blind Therapy Period.
Participants by arm
| Arm | Count |
|---|---|
| Olanzapine Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks. | 68 |
| Risperidone Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks. | 62 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 5 |
| Overall Study | Lack of Efficacy | 2 | 3 |
| Overall Study | Lost to Follow-up | 8 | 11 |
| Overall Study | Protocol Violation | 5 | 4 |
| Overall Study | Reason Not Specified | 0 | 2 |
| Overall Study | Sponsor Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 10 | 6 |
Baseline characteristics
| Characteristic | Olanzapine | Risperidone | Total |
|---|---|---|---|
| Age Continuous | 43.49 years STANDARD_DEVIATION 9.45 | 42.58 years STANDARD_DEVIATION 8.98 | 43.06 years STANDARD_DEVIATION 9.2 |
| Brief Psychiatric Rating Scale Anxiety Depression Score-Baseline | 4.46 units on a scale STANDARD_DEVIATION 2.46 | 3.74 units on a scale STANDARD_DEVIATION 2.13 | 4.12 units on a scale STANDARD_DEVIATION 2.33 |
| Brief Psychiatric Rating Scale Negative Symptom Score-Baseline | 2.28 units on a scale STANDARD_DEVIATION 1.98 | 1.89 units on a scale STANDARD_DEVIATION 1.79 | 2.09 units on a scale STANDARD_DEVIATION 1.89 |
| Brief Psychiatric Rating Scale Positive Symptom Score-Baseline | 5.40 units on a scale STANDARD_DEVIATION 2.69 | 5.47 units on a scale STANDARD_DEVIATION 2.52 | 5.43 units on a scale STANDARD_DEVIATION 2.6 |
| Brief Psychiatric Rating Scale Total Score-Baseline | 15.63 units on a scale STANDARD_DEVIATION 6.06 | 14.29 units on a scale STANDARD_DEVIATION 6 | 14.99 units on a scale STANDARD_DEVIATION 6.04 |
| Clinical Global Impression Severity Score- Baseline | 3.68 units on a scale STANDARD_DEVIATION 0.56 | 3.65 units on a scale STANDARD_DEVIATION 0.52 | 3.66 units on a scale STANDARD_DEVIATION 0.54 |
| Diagnosis Schizoaffective disorder | 27 participants | 16 participants | 43 participants |
| Diagnosis Schizophrenia,paranoid | 40 participants | 45 participants | 85 participants |
| Diagnosis Schizophrenia, undifferentiated | 1 participants | 1 participants | 2 participants |
| Extrapyramidal Scores/Abnormal Involuntary Movement-Baseline | 0.42 units on a scale STANDARD_DEVIATION 1.14 | 0.47 units on a scale STANDARD_DEVIATION 1.13 | 0.44 units on a scale STANDARD_DEVIATION 1.13 |
| Extrapyramidal Scores/Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment-Baseline | 0.27 units on a scale STANDARD_DEVIATION 0.66 | 0.32 units on a scale STANDARD_DEVIATION 0.67 | 0.29 units on a scale STANDARD_DEVIATION 0.67 |
| Extrapyramidal Scores/Simpson-Angus-Baseline | 0.97 units on a scale STANDARD_DEVIATION 1.87 | 0.90 units on a scale STANDARD_DEVIATION 1.8 | 0.94 units on a scale STANDARD_DEVIATION 1.83 |
| Race/Ethnicity African descent | 34 participants | 26 participants | 60 participants |
| Race/Ethnicity Caucasian | 27 participants | 30 participants | 57 participants |
| Race/Ethnicity East Asian | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity Hispanic | 4 participants | 5 participants | 9 participants |
| Race/Ethnicity Other | 2 participants | 1 participants | 3 participants |
| Region of Enrollment United States | 68 participants | 62 participants | 130 participants |
| Sex: Female, Male Female | 23 Participants | 21 Participants | 44 Participants |
| Sex: Female, Male Male | 45 Participants | 41 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 42 / 68 | 43 / 62 |
| serious Total, serious adverse events | 2 / 68 | 5 / 62 |
Outcome results
Primary
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
Population: N=number of patients with a baseline and post-baseline result within each treatment group for Mffm/I and weight.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olanzapine | Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate | Baseline | 0.1664 Mffm/I | Standard Deviation 0.112 |
| Olanzapine | Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate | Change to Last Observation | -0.0149 Mffm/I | Standard Deviation 0.0786 |
| Risperidone | Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate | Baseline | 0.1937 Mffm/I | Standard Deviation 0.1286 |
| Risperidone | Change in Baseline to Last Observation In Normalized Insulin Sensitivity Index at Low Insulin Phase Using Change in Weight as a Covariate | Change to Last Observation | -0.0327 Mffm/I | Standard Deviation 0.0829 |
p-value: 0.226t-test, 2 sided
p-value: 0.03t-test, 2 sided
p-value: 0.204ANCOVA
Secondary
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
Population: Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olanzapine | Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores | Baseline | 0.48 units on a scale | Standard Deviation 1.24 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores | Change to last observation | 0.04 units on a scale | Standard Deviation 1.15 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores | Baseline | 0.53 units on a scale | Standard Deviation 1.25 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Abnormal Involuntary Movement Scale Scores | Change to last observation | 0.04 units on a scale | Standard Deviation 1.35 |
p-value: 0.943t-test, 2 sided
p-value: 0.763t-test, 2 sided
p-value: 0.832ANCOVA
Secondary
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
Population: Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olanzapine | Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores | Baseline | 0.24 units on a scale | Standard Deviation 0.64 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores | Change to last observation | 0.02 units on a scale | Standard Deviation 0.84 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores | Baseline | 0.36 units on a scale | Standard Deviation 0.7 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Barnes Akathisia Rating Scale (BARS) Scores | Change to last observation | -0.02 units on a scale | Standard Deviation 0.82 |
p-value: 0.623t-test, 2 sided
p-value: 0.853t-test, 2 sided
p-value: 0.591ANCOVA
Secondary
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
Population: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olanzapine | Change From Baseline to 12 Week Endpoint in Body Mass Index | Baseline | 28.96 kilograms per square meter (kg/m2) | Standard Deviation 5.17 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Body Mass Index | Change to Last Observation | 1.02 kilograms per square meter (kg/m2) | Standard Deviation 1.61 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Body Mass Index | Baseline | 28.79 kilograms per square meter (kg/m2) | Standard Deviation 5.4 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Body Mass Index | Change to Last Observation | 0.39 kilograms per square meter (kg/m2) | Standard Deviation 1.15 |
p-value: <0.001t-test, 2 sided
p-value: 0.019t-test, 2 sided
p-value: 0.065ANCOVA
Secondary
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
Population: BPRS Total and Subscale Scores-Change from Baseline to Last Observation Carried Forward, all randomized patients, double-blind treatment period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olanzapine | Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores | Total Score Baseline | 13.32 units on a scale | Standard Deviation 6.26 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores | Total Score Change to Last Observation | -1.98 units on a scale | Standard Deviation 6.3 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores | Positive Subscale Score Baseline | 5.22 units on a scale | Standard Deviation 2.75 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores | Positive Subscale Score Change to Last Observation | -0.82 units on a scale | Standard Deviation 2.81 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores | Negative Subscale Score Baseline | 2.32 units on a scale | Standard Deviation 2.04 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores | Negative Subscale Score Change to Last Observation | -0.38 units on a scale | Standard Deviation 1.58 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores | Anxiety-Depression Baseline | 4.33 units on a scale | Standard Deviation 2.59 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores | Anxiety-Depression Change to Last Observation | -0.78 units on a scale | Standard Deviation 2.29 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores | Anxiety-Depression Change to Last Observation | -0.32 units on a scale | Standard Deviation 2.5 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores | Total Score Baseline | 13.96 units on a scale | Standard Deviation 6.02 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores | Negative Subscale Score Baseline | 1.88 units on a scale | Standard Deviation 1.83 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores | Total Score Change to Last Observation | -1.48 units on a scale | Standard Deviation 7.99 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores | Anxiety-Depression Baseline | 3.73 units on a scale | Standard Deviation 2.18 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores | Positive Subscale Score Baseline | 5.27 units on a scale | Standard Deviation 2.51 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores | Negative Subscale Score Change to Last Observation | -0.02 units on a scale | Standard Deviation 1.99 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Brief Psychiatric Rating Scale (BPRS) Scores | Positive Subscale Score Change to Last Observation | -1.20 units on a scale | Standard Deviation 3.08 |
Comparison: Total Scorep-value: 0.111t-test, 2 sided
Comparison: Total Scorep-value: 0.159t-test, 2 sided
Comparison: Total Scorep-value: 0.951ANCOVA
Comparison: Positive Subscalep-value: 0.012t-test, 2 sided
Comparison: Positive subscalep-value: 0.002t-test, 2 sided
Comparison: Positive subscalep-value: 0.467ANCOVA
Comparison: Negative subscalep-value: 0.365t-test, 2 sided
Comparison: Negative subscalep-value: 0.846t-test, 2 sided
Comparison: Negative subscalep-value: 0.559ANCOVA
Comparison: Anxiety-Depression subscalep-value: 0.15t-test, 2 sided
Comparison: Anxiety-Depression subscalep-value: 0.612t-test, 2 sided
Comparison: Anxiety-Depression subscalep-value: 0.475ANCOVA
Secondary
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
Population: Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olanzapine | Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores | Baseline | 3.65 units on a scale | Standard Deviation 0.55 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores | Change to last observation | -0.22 units on a scale | Standard Deviation 0.58 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores | Baseline | 3.61 units on a scale | Standard Deviation 0.53 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Clinical Global Impression - Severity of Illness Scores | Change to last observation | -0.23 units on a scale | Standard Deviation 0.66 |
p-value: 0.012t-test, 2 sided
p-value: 0.01t-test, 2 sided
p-value: 0.76ANCOVA
Secondary
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
Population: Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olanzapine | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 1 Baseline (How Hungry?) | 1.42 units on a scale | Standard Deviation 1.09 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 1 Change to Last Observation | 0.25 units on a scale | Standard Deviation 1.27 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 2 Baseline (How Strong Appetite?) | 1.54 units on a scale | Standard Deviation 1.1 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 2 Change to Last Observation | 0.17 units on a scale | Standard Deviation 1.26 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 3 Baseline (Craved Sweets or Other Carbos?) | 1.00 units on a scale | Standard Deviation 1.17 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 3 Change to Last Observation | 0.19 units on a scale | Standard Deviation 1.47 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 4 Baseline (Craved Fatty Foods?) | 0.80 units on a scale | Standard Deviation 1.01 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 4 Change to Last Observation | 0.31 units on a scale | Standard Deviation 1.52 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 5 Baseline (Felt Full After Meal?) | 2.59 units on a scale | Standard Deviation 0.93 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 5 Change to Last Observation | -0.17 units on a scale | Standard Deviation 1.15 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 6 Baseline(Excessive Food to Feel Satisfied?) | 0.86 units on a scale | Standard Deviation 1.21 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 6 Change to Last Observation | 0.17 units on a scale | Standard Deviation 1.4 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 7 Baseline (Thinking About Food?) | 0.90 units on a scale | Standard Deviation 1.18 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 7 Change to Last Observation | 0.12 units on a scale | Standard Deviation 1.31 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 8 Baseline (Overeating?) | 0.42 units on a scale | Standard Deviation 0.95 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 8 Change to Last Observation | 0.17 units on a scale | Standard Deviation 1.33 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 9 Baseline (Feel Eating is Out of Control?) | 0.10 units on a scale | Standard Deviation 0.36 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 9 Change to Last Observation | 0.25 units on a scale | Standard Deviation 0.94 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 7 Change to Last Observation | 0.13 units on a scale | Standard Deviation 1.36 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 1 Baseline (How Hungry?) | 1.32 units on a scale | Standard Deviation 0.94 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 5 Change to Last Observation | 0.00 units on a scale | Standard Deviation 1.19 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 1 Change to Last Observation | 0.42 units on a scale | Standard Deviation 1.18 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 9 Change to Last Observation | 0.11 units on a scale | Standard Deviation 1.01 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 2 Baseline (How Strong Appetite?) | 1.32 units on a scale | Standard Deviation 1.03 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 6 Baseline(Excessive Food to Feel Satisfied?) | 0.79 units on a scale | Standard Deviation 1.12 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 2 Change to Last Observation | 0.38 units on a scale | Standard Deviation 1.33 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 8 Baseline (Overeating?) | 0.53 units on a scale | Standard Deviation 1.08 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 3 Baseline (Craved Sweets or Other Carbos?) | 0.83 units on a scale | Standard Deviation 1.1 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 6 Change to Last Observation | 0.28 units on a scale | Standard Deviation 1.25 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 3 Change to Last Observation | 0.36 units on a scale | Standard Deviation 1.18 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 9 Baseline (Feel Eating is Out of Control?) | 0.26 units on a scale | Standard Deviation 0.76 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 4 Baseline (Craved Fatty Foods?) | 0.74 units on a scale | Standard Deviation 1 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 7 Baseline (Thinking About Food?) | 0.77 units on a scale | Standard Deviation 1.14 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 4 Change to Last Observation | 0.25 units on a scale | Standard Deviation 1.05 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 8 Change to Last Observation | 0.15 units on a scale | Standard Deviation 1.31 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Eating Behavior Assessment Scale Scores | Item 5 Baseline (Felt Full After Meal?) | 2.55 units on a scale | Standard Deviation 0.89 |
Comparison: Item 1p-value: 0.004t-test, 2 sided
Comparison: Item 1p-value: 0.001t-test, 2 sided
Comparison: Item 1p-value: 0.549ANCOVA
Comparison: Item 2p-value: 0.011t-test, 2 sided
Comparison: Item 2p-value: 0.009t-test, 2 sided
Comparison: Item 2p-value: 0.793ANCOVA
Comparison: Item 3p-value: 0.045t-test, 2 sided
Comparison: Item 3p-value: 0.027t-test, 2 sided
Comparison: Item 3p-value: 0.699ANCOVA
Comparison: Item 4p-value: 0.002t-test, 2 sided
Comparison: ITem 4p-value: 0.019t-test, 2 sided
Comparison: Item 4p-value: 0.733ANCOVA
Comparison: Item 5p-value: 0.034t-test, 2 sided
Comparison: Item 5p-value: 0.235t-test, 2 sided
Comparison: Item 5p-value: 0.532ANCOVA
Comparison: Item 6p-value: 0.242t-test, 2 sided
Comparison: Item 6p-value: 0.186t-test, 2 sided
Comparison: Item 6p-value: 0.799ANCOVA
Comparison: Item 7p-value: 0.097t-test, 2 sided
Comparison: Item 7p-value: 0.214t-test, 2 sided
Comparison: Item 7p-value: 0.827ANCOVA
Comparison: Item 8p-value: 0.151t-test, 2 sided
Comparison: Item 8p-value: 0.071t-test, 2 sided
Comparison: Item 8p-value: 0.629ANCOVA
Comparison: Item 9p-value: 0.036t-test, 2 sided
Comparison: Item 9p-value: 0.112t-test, 2 sided
Comparison: Item 9p-value: 0.806ANCOVA
Secondary
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
Population: Change from baseline to last observation, all randomized patients, double-blind treatment period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olanzapine | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL) | Baseline | 3.18 millimoles per Liter (mmol/L) | Standard Deviation 0.9 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL) | Change to last observation | -0.03 millimoles per Liter (mmol/L) | Standard Deviation 0.67 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL) | Baseline | 3.11 millimoles per Liter (mmol/L) | Standard Deviation 0.99 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Direct Low Density Lipoprotein (LDL) | Change to last observation | -0.02 millimoles per Liter (mmol/L) | Standard Deviation 0.63 |
p-value: 0.74t-test, 2 sided
p-value: 0.76t-test, 2 sided
p-value: 0.997ANCOVA
Secondary
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
Population: Change from baseline to last observation, all randomized patients, double-blind treatment period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olanzapine | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL) | Baseline | 1.08 millimoles per Liter (mmol/L) | Standard Deviation 0.25 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL) | Change to last observation | 0.06 millimoles per Liter (mmol/L) | Standard Deviation 0.24 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL) | Baseline | 1.18 millimoles per Liter (mmol/L) | Standard Deviation 0.32 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including High Density Lipoprotein (HDL) | Change to last observation | 0.05 millimoles per Liter (mmol/L) | Standard Deviation 0.27 |
p-value: 0.176t-test, 2 sided
p-value: 0.237t-test, 2 sided
p-value: 0.996ANCOVA
Secondary
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.
Population: Mean change from baseline, all randomized patients, double-blind treatment period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olanzapine | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | HDL particles, total, baseline | 28.39 nanomoles per Liter (nmol/L) | Standard Deviation 5.38 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | HDL particles, total, change to last observation | 1.71 nanomoles per Liter (nmol/L) | Standard Deviation 4.84 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | IDL, baseline | 53.18 nanomoles per Liter (nmol/L) | Standard Deviation 55.32 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | IDL, change to last observation | 21.40 nanomoles per Liter (nmol/L) | Standard Deviation 59.63 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | Medium small LDL, baseline | 175.15 nanomoles per Liter (nmol/L) | Standard Deviation 98.59 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | Medium small LDL, change to last observation | 35.70 nanomoles per Liter (nmol/L) | Standard Deviation 52.4 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | Small LDL, baseline | 878.68 nanomoles per Liter (nmol/L) | Standard Deviation 481.65 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | Small LDL, change to last observation | 128.55 nanomoles per Liter (nmol/L) | Standard Deviation 236.89 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | Very small LDL, baseline | 703.63 nanomoles per Liter (nmol/L) | Standard Deviation 385.31 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | Very small LDL, change to last observation | 92.75 nanomoles per Liter (nmol/L) | Standard Deviation 193 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | VLDL mean particle size, baseline | 51.21 nanomoles per Liter (nmol/L) | Standard Deviation 8.57 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | VLDL mean particle size, change to last observ. | 4.09 nanomoles per Liter (nmol/L) | Standard Deviation 7.83 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | VLDL mean particle size, baseline | 51.05 nanomoles per Liter (nmol/L) | Standard Deviation 11.83 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | HDL particles, total, baseline | 29.81 nanomoles per Liter (nmol/L) | Standard Deviation 5.29 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | Small LDL, baseline | 977.84 nanomoles per Liter (nmol/L) | Standard Deviation 622.99 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | HDL particles, total, change to last observation | -1.09 nanomoles per Liter (nmol/L) | Standard Deviation 4.34 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | Very small LDL, change to last observation | -62.50 nanomoles per Liter (nmol/L) | Standard Deviation 347.08 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | IDL, baseline | 52.56 nanomoles per Liter (nmol/L) | Standard Deviation 61.38 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | Small LDL, change to last observation | -74.09 nanomoles per Liter (nmol/L) | Standard Deviation 428.13 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | IDL, change to last observation | -2.69 nanomoles per Liter (nmol/L) | Standard Deviation 46.07 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | VLDL mean particle size, change to last observ. | 1.80 nanomoles per Liter (nmol/L) | Standard Deviation 9.21 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | Medium small LDL, baseline | 197.00 nanomoles per Liter (nmol/L) | Standard Deviation 116.28 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | Very small LDL, baseline | 780.78 nanomoles per Liter (nmol/L) | Standard Deviation 508.24 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Lipoprotein Subclasses | Medium small LDL, change to last observation | -11.47 nanomoles per Liter (nmol/L) | Standard Deviation 84.73 |
Comparison: HDL particles, totalp-value: 0.009t-test, 2 sided
Comparison: HDL particles, totalp-value: 0.959t-test, 2 sided
Comparison: HDL particles, totalp-value: 0.038ANCOVA
Comparison: IDLp-value: 0.013t-test, 2 sided
Comparison: IDLp-value: 0.928t-test, 2 sided
Comparison: IDLp-value: 0.049ANCOVA
Comparison: Medium small LDLp-value: 0.009t-test, 2 sided
Comparison: Medium small LDLp-value: 0.662t-test, 2 sided
Comparison: Medium small LDLp-value: 0.12ANCOVA
Comparison: Small LDLp-value: 0.099t-test, 2 sided
Comparison: Small LDLp-value: 0.304t-test, 2 sided
Comparison: Small LDLp-value: 0.024ANCOVA
Comparison: Very small LDLp-value: 0.176t-test, 2 sided
Comparison: Very small LDLp-value: 0.246t-test, 2 sided
Comparison: Very small LDLp-value: 0.033ANCOVA
Comparison: VLDL mean particle sizep-value: <0.001t-test, 2 sided
Comparison: VLDL mean particle sizep-value: 0.047t-test, 2 sided
Comparison: VLDL mean particle sizep-value: 0.221ANCOVA
Secondary
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
Population: Change from baseline to last observation, all randomized patients, double-blind treatment period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olanzapine | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol | Baseline | 4.91 millimoles per Liter (mmol/L) | Standard Deviation 1.06 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol | Change to Last Observation | 0.18 millimoles per Liter (mmol/L) | Standard Deviation 0.89 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol | Baseline | 4.97 millimoles per Liter (mmol/L) | Standard Deviation 1.12 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Total Cholesterol | Change to Last Observation | 0.01 millimoles per Liter (mmol/L) | Standard Deviation 0.79 |
p-value: 0.156t-test, 2 sided
p-value: 0.829t-test, 2 sided
p-value: 0.352ANCOVA
Secondary
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
Population: Change from baseline to last observation, all randomized patients, double-blind treatment period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olanzapine | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides | Baseline | 1.68 millimoles per Liter (mmol/L) | Standard Deviation 0.91 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides | Change to Last Observation | 0.34 millimoles per Liter (mmol/L) | Standard Deviation 1.12 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides | Baseline | 1.55 millimoles per Liter (mmol/L) | Standard Deviation 0.85 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Fasting Lipid Parameters Including Triglycerides | Change to Last Observation | -0.10 millimoles per Liter (mmol/L) | Standard Deviation 0.74 |
p-value: 0.027t-test, 2 sided
p-value: 0.545t-test, 2 sided
p-value: 0.024ANCOVA
Secondary
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
Population: Change from baseline to last observation carried forward, all randomized patients, double-blind treatment period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olanzapine | Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores | Baseline | 1.13 units on a scale | Standard Deviation 2.02 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores | Change to last observation | -0.06 units on a scale | Standard Deviation 1.48 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores | Baseline | 0.94 units on a scale | Standard Deviation 1.79 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Simpson Angus Scale Scores | Change to last observation | 0.30 units on a scale | Standard Deviation 1.92 |
p-value: 0.302t-test, 2 sided
p-value: 0.922t-test, 2 sided
p-value: 0.479ANCOVA
Secondary
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
Population: Abdominal CT scan change from baseline to last observation for randomized patients who completed baseline and endpoint clamps with both diet stabilizations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olanzapine | Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area | Baseline | 281.07 square centimeters (cm2) | Standard Deviation 158.59 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area | Change to last observation | 4.94 square centimeters (cm2) | Standard Deviation 40.36 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area | Change to last observation | 35.15 square centimeters (cm2) | Standard Deviation 105.64 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area | Baseline | 317.16 square centimeters (cm2) | Standard Deviation 172.19 |
p-value: 0.406t-test, 2 sided
p-value: 0.011t-test, 2 sided
p-value: 0.076ANCOVA
Secondary
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
Population: Abdominal CT scan change from baseline to last observation of randomized patients who completed the baseline and endpoint clamps with both diet stabilizations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olanzapine | Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area | Baseline | 0.41 ratio in square centimeters (cm2) | Standard Deviation 0.25 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area | Change to last observation | 0.01 ratio in square centimeters (cm2) | Standard Deviation 0.12 |
| Risperidone | Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area | Baseline | 0.43 ratio in square centimeters (cm2) | Standard Deviation 0.33 |
| Risperidone | Change From Baseline to 12 Week Endpoint in the Ratio of the Visceral Fat Area to the Subcutaneous Fat Area | Change to last observation | 0.00 ratio in square centimeters (cm2) | Standard Deviation 0.14 |
p-value: 0.456t-test, 2 sided
p-value: 0.712t-test, 2 sided
p-value: 0.689ANCOVA
Secondary
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
Population: Abdominal CT scan of changes from baseline to last observation of randomized patients who completed baseline and endpoint clamps with both diet stabilizations
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olanzapine | Change From Baseline to 12 Week Endpoint in Visceral Fat Area | Baseline | 101.46 square centimeters (cm2) | Standard Deviation 54.99 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Visceral Fat Area | Change to Last Observation | 4.70 square centimeters (cm2) | Standard Deviation 21.21 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Visceral Fat Area | Baseline | 102.17 square centimeters (cm2) | Standard Deviation 52.61 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Visceral Fat Area | Change to Last Observation | 8.70 square centimeters (cm2) | Standard Deviation 42.39 |
p-value: 0.274t-test, 2 sided
p-value: 0.105t-test, 2 sided
p-value: 0.609ANCOVA
Secondary
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
Population: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olanzapine | Change From Baseline to 12 Week Endpoint in Waist Circumference | Baseline | 99.13 centimeters | Standard Deviation 14.42 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Waist Circumference | Change to Last Observation | 2.38 centimeters | Standard Deviation 7.46 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Waist Circumference | Baseline | 98.49 centimeters | Standard Deviation 11.6 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Waist Circumference | Change to Last Observation | 0.17 centimeters | Standard Deviation 4.99 |
p-value: 0.007t-test, 2 sided
p-value: 0.266t-test, 2 sided
p-value: 0.239ANCOVA
Secondary
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
Population: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olanzapine | Change From Baseline to 12 Week Endpoint in Weight | Baseline | 85.93 kilograms | Standard Deviation 17.26 |
| Olanzapine | Change From Baseline to 12 Week Endpoint in Weight | Change to Last Observation | 2.98 kilograms | Standard Deviation 4.82 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Weight | Baseline | 86.55 kilograms | Standard Deviation 19.53 |
| Risperidone | Change From Baseline to 12 Week Endpoint in Weight | Change to Last Observation | 1.23 kilograms | Standard Deviation 4.45 |
p-value: <0.001t-test, 2 sided
p-value: 0.013t-test, 2 sided
p-value: 0.076ANCOVA
Secondary
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
Population: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olanzapine | Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores. | -0.120 correlation |
| Risperidone | Pairwise Correlation Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Barnes Akathisia Scale Scores. | 0.006 correlation |
p-value: 0.454Pearson's correlation coefficient
p-value: 0.974Pearson's correlation coefficient
Secondary
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
Population: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olanzapine | Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. | Item 2: How Strong Appetite? | -0.137 correlation |
| Olanzapine | Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. | Item 6:Excessive Amount of Food to Feel Satisfied? | 0.134 correlation |
| Olanzapine | Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. | Item 4: Craved Fatty Foods? | -0.068 correlation |
| Olanzapine | Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. | Item 7: Thinking About Food? | -0.172 correlation |
| Olanzapine | Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. | Item 3: Craved Sweets or Other Carbohydrates? | -0.009 correlation |
| Olanzapine | Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. | Item 8: Overeating? | -0.032 correlation |
| Olanzapine | Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. | Item 5: Felt Full or Satisfied After Meal? | -0.117 correlation |
| Olanzapine | Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. | Item 9: Feel Eating is Out of Control? | -0.075 correlation |
| Olanzapine | Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. | Item 1: How Hungry? | -0.137 correlation |
| Risperidone | Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. | Item 9: Feel Eating is Out of Control? | -0.354 correlation |
| Risperidone | Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. | Item 1: How Hungry? | -0.371 correlation |
| Risperidone | Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. | Item 2: How Strong Appetite? | -0.269 correlation |
| Risperidone | Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. | Item 3: Craved Sweets or Other Carbohydrates? | 0.035 correlation |
| Risperidone | Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. | Item 4: Craved Fatty Foods? | -0.184 correlation |
| Risperidone | Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. | Item 5: Felt Full or Satisfied After Meal? | -0.060 correlation |
| Risperidone | Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. | Item 6:Excessive Amount of Food to Feel Satisfied? | 0.067 correlation |
| Risperidone | Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. | Item 7: Thinking About Food? | 0.045 correlation |
| Risperidone | Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. | Item 8: Overeating? | -0.165 correlation |
Comparison: Change in Eating Behavior Item 1p-value: 0.393Pearson's correlation coefficient
Comparison: Change in Eating Behavior Item 1p-value: 0.033Pearson's correlation coefficient
Comparison: Change in Eating Behavior Item 2p-value: 0.392Pearson's correlation coefficient
Comparison: Change in Eating Behavior Item 2p-value: 0.129Pearson's correlation coefficient
Comparison: Change in Eating Bahavior Item 3p-value: 0.956Pearson's correlation coefficient
Comparison: Change in Eating Behavior Item 3p-value: 0.846Pearson's correlation coefficient
Comparison: Change in Eating Behavior Item 4p-value: 0.675Pearson's correlation coefficient
Comparison: Change in Eating Behavior Item 4p-value: 0.306Pearson's correlation coefficient
Comparison: Change in Eating Behavior Item 5p-value: 0.468Pearson's correlation coefficient
Comparison: Change in Eating Behavior Item 5p-value: 0.739Pearson's correlation coefficient
Comparison: Change in Eating Behavior Item 6p-value: 0.404Pearson's correlation coefficient
Comparison: Change in Eating Behavior Item 6p-value: 0.711Pearson's correlation coefficient
Comparison: Change in Eating Behavior Item 7p-value: 0.281Pearson's correlation coefficient
Comparison: Change in Eating Behavior Item 7p-value: 0.805Pearson's correlation coefficient
Comparison: Change in Eating Behavior Item 8p-value: 0.844Pearson's correlation coefficient
Comparison: Change in Eating Bahavior Item 8p-value: 0.359Pearson's correlation coefficient
Comparison: Change in Eating Behavior Item 9p-value: 0.642Pearson's correlation coefficient
Comparison: Change in Eating Behavior Item 9p-value: 0.043Pearson's correlation coefficient
Secondary
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
Population: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olanzapine | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores. | 0.001 correlation |
| Risperidone | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Abnormal Involuntary Movement Scale Scores. | -0.134 correlation |
p-value: 0.994Pearson's correlation coefficient
p-value: 0.456Pearson's correlation coefficient
Secondary
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
Population: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olanzapine | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI) | -0.182 correlation |
| Risperidone | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Body Mass Index (BMI) | -0.195 correlation |
p-value: 0.256Pearson's correlation coefficient
p-value: 0.277Pearson's correlation coefficient
Secondary
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
Population: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olanzapine | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores. | 0.035 correlation |
| Risperidone | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Brief Psychiatric Rating Scale Scores. | 0.066 correlation |
p-value: 0.829Pearson's correlation coefficient
p-value: 0.714Pearson's correlation coefficient
Secondary
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
Population: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olanzapine | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores. | 0.068 correlation |
| Risperidone | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Clinical Global Impression - Severity of Illness Scale Scores. | 0.234 correlation |
p-value: 0.672Pearson's correlation coefficient
p-value: 0.191Pearson's correlation coefficient
Secondary
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
Population: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olanzapine | 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. | -0.055 correlation |
| Risperidone | 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. | 0.101 correlation |
p-value: 0.766Pearson's correlation coefficient
p-value: 0.622Pearson's correlation coefficient
Secondary
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
Population: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olanzapine | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area. | -0.043 correlation |
| Risperidone | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area. | -0.085 correlation |
p-value: 0.815Pearson's correlation coefficient
p-value: 0.675Pearson's correlation coefficient
Secondary
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
Population: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olanzapine | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores. | 0.184 correlation |
| Risperidone | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in the Simpson Angus Scale Scores. | 0.249 correlation |
p-value: 0.249Pearson's correlation coefficient
p-value: 0.163Pearson's correlation coefficient
Secondary
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
Population: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olanzapine | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area. | -0.048 correlation |
| Risperidone | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Visceral Fat Area. | -0.057 correlation |
p-value: 0.793Pearson's correlation coefficient
p-value: 0.777Pearson's correlation coefficient
Secondary
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
Population: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olanzapine | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference. | -0.206 correlation |
| Risperidone | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Waist Circumference. | -0.263 correlation |
p-value: 0.201Pearson's correlation coefficient
p-value: 0.168Pearson's correlation coefficient
Secondary
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
Population: Randomized patients who completed the baseline and endpoint clamps with both diet stabilizations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olanzapine | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight. | -0.212 correlation |
| Risperidone | Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight. | -0.188 correlation |
p-value: 0.184Pearson's correlation coefficient
p-value: 0.295Pearson's correlation coefficient