- Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Weight. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in visceral fat area
- Pairwise Correlations Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Subcutaneous Fat Area. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Normalized insulin sensitivity index (Mffm/I) at low insulin phase-pairwise correlations between changes in Mffm/I and changes in subcutaneous fat area
- Pairwise Correlations Between Between Changes in Normalized Insulin Sensitivity Index at Low Insulin Phase and Changes in Eating Behavior Assessment Scale Scores. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
Weight change from baseline to last visit (last observation carried forward)
- Change From Baseline to 12 Week Endpoint in Waist Circumference [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
Waist circumference change from baseline to last observation carried forward.
- Change From Baseline to 12 Week Endpoint in Visceral Fat Area [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
Visceral fat area change from baseline to last observation carried forward, all randomized patients, double-blind treatment period
- Change From Baseline to 12 Week Endpoint in Subcutaneous Fat Area [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: baseline and 12 weeks. ] [ Designated as safety issue: Yes ]
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.
Purpose
