This study will assess whether olanzapine and/or risperidone affect the way the human body uses sugar in the blood.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
130
5-20 mg, oral, capsules, daily, 12 weeks.
2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
San Diego, California, United States
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
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
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
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
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
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Time frame: 12 weeks
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.