Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine

Mean Change From Baseline to Endpoint in Fasting Triglycerides

Time frame: Baseline to endpoint (22 weeks)

Mean Change From Baseline to Endpoint in Fasting Total Cholesterol

Time frame: Baseline to endpoint (22 weeks)

Mean Change From Baseline to Endpoint in Fasting High Density Lipoprotein (HDL) Cholesterol

Time frame: Baseline to endpoint (22 weeks)

Mean Change From Baseline to Endpoint in Fasting Low Density Lipoprotein (LDL) Cholesterol

Time frame: Baseline to endpoint (22 weeks)

Mean Change From Baseline to Endpoint in Fasting Glucose

Time frame: Baseline to endpoint (22 weeks)

Mean Change From Baseline to Endpoint in Hemoglobin A1c

Time frame: Baseline to endpoint (22 weeks)

Change From Baseline to Endpoint in Brief Psychiatric Rating Scale (BPRS) Total Score

The BPRS is an 18-item clinician-administered scale used to assess the degree of severity of a subject's general psychopathological symptoms. Each item is rated on a scale from 1 (symptom not present) to 7 (symptom extremely severe). The BPRS total score ranges from 18 to 126.

Time frame: Baseline to endpoint (22 weeks)

Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).

Time frame: Baseline to endpoint (22 weeks)

Change From Baseline to Endpoint in Clinical Global Impression - Severity Scale (CGI-S)

Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

Time frame: Baseline to endpoint (22 weeks)

Correlations Between Weight Changes and Changes in Eating Inventory (EI) and Food Craving Inventory (FCI) at 2 Weeks and 22 Weeks

To understand the drivers of weight gain as indicated by the correlation between weight changes and changes in the Eating Inventory (EI) and Food Craving Inventory (FCI). The EI is a 51-item inventory that measures dietary restraint, disinhibition, and perceived hunger. The FCI is a 28-item instrument measuring the frequency over the past month of general cravings and cravings for specific types of foods, namely: high fats, sweets, carbohydrates/starches, and fast-food fats. Correlations were computed on the combined treatment groups.

Time frame: Baseline to endpoint (22 weeks)