A Phase 4 Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome

Number of Participants Remaining on Metabolic Syndrome at Week 16

Metabolic syndrome is defined as the presence of at least 3 out of the following Adult Treatment Panel III-A (ATP III-A) criteria (all of which are to be assessed at the same visit): waist \>102 cm in males, \>88 cm in females; blood pressure (BP) systolic BP ≥130 or diastolic BP ≥85 mm Hg; fasting HDL \<40 mg/dL in males, \<50 mg/dL in females; fasting triglycerides ≥150 mg/dL; fasting glucose ≥100 mg/dL, and/or the start of a treatment for any of the parameters of metabolic syndrome during the course of the study.

Time frame: Week 16

Mean Percent Change From Baseline in Fasting Lipid Parameters Through Week 16

Mean percent change from baseline in total cholesterol, low-density lipoprotein (LDL), HDL, and triglycerides.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 16

Mean Change From Baseline for Fasting Glucose Levels Through Week 16

Time frame: Baseline, Week 4, Week 8, Week 12, Week 16

Mean Change From Baseline in Body Weight Through Week 16

Time frame: Baseline, Week 4, Week 8, Week 12, Week 16

Median Change From Baseline in Body Mass Index (BMI) Through Week 16

Time frame: Baseline, Week 4, Week 8, Week 12, Week 16

Mean Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale Through Week 16

A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=normal; 7=among the most extremely ill patients). A decrease in value indicates improvement.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 16

Mean Change From Baseline in Subjective Well-Being Under Neuroleptics Scale (SWN-short Form) Through Week 16

The SWN-short form is a 20-item self-report instrument that measures subjective well-being under neuroleptics. 10 positive and 10 negative items cover 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). With negative item scores being reversed, Subscale scores range from 4 to 24 and Total score ranges from 20 to 120.

Time frame: Baseline, Week 4, Week 8,Week 12, Week 16

Mean Change From Baseline in the Impact of Weight on Quality of Life (IWQoL-Lite) Scale Through Week 16

IWQoL-Lite is a 31-item self-report inventory to assess the impact of weight on quality of life among patients with obesity. Subscales include: Physical Function, Self Esteem, Sexual Life, Public Distress and Work. The rescaled IWQoL-Lite Total Score is determined by the sum of the 1 to 5 scores on all 31 items and rescaling this sum to a 0-100 scoring with 0=the poorest and 100=the best quality of life. A change of 7.8 to 12.0 points on the rescaled IWQoL-Lite Total Score=a meaningful improvement. A change of -4.5 to -7.6 on the rescaled IWQoL-Lite Total Score=a meaningful deterioration.

Time frame: Baseline, Week 4, Week 8, Week 12, Week 16