Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three subjects of the 462 enrolled did not receive study medication and were excluded from analysis: 2 subjects were randomized by mistake by the investigator and 1 subject withdrew consent before first intake of study medication. The ITT population consisted of 459 subjects who took at least one dose of study medication.

Reporting Groups

	Description
Paliperidone Extended Release (ER)	6-mg or 9-mg tablet once daily flexible dosing for 6 months
Olanzapine	10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months

Participant Flow:   Overall Study

	Paliperidone Extended Release (ER)	Olanzapine
STARTED	239	220
COMPLETED	168	178
NOT COMPLETED	71	42
Lack of Efficacy	15	6
Withdrawal by Subject	30	22
Lost to Follow-up	6	4
Adverse Event	11	5
Other	9	5

Reporting Groups

	Description
Paliperidone ER	6-mg or 9-mg tablet once daily flexible dosing for 6 months
Olanzapine	10-15 mg (using 5-mg or 10-mg tablets) once daily flexible dosing for 6 months

Baseline Measures

	Paliperidone ER	Olanzapine	Total
Number of Participants   [units: participants]	239	220	459
Age   [units: years] Mean ± Standard Deviation	38.8  ± 11.1	37.5  ± 11.4	38.2  ± 11.2
Gender   [units: participants]
Female	106	87	193
Male	133	133	266
Body Mass Index (BMI)   [units: kg/m²] Mean ± Standard Deviation	26.9  ± 6.31	27.0  ± 5.73	26.9  ± 6.03
Waist   [units: cm] Mean ± Standard Deviation	92.2  ± 14.4	93.3  ± 15.6	92.7  ± 14.9
Weight   [units: kg] Mean ± Standard Deviation	75.9  ± 17.0	77.9  ± 16.5	76.9  ± 16.8

1.  Primary:

Change From Baseline to End Point in the Triglycerides (TG) to High Density Lipoprotein (HDL) Ratio (TG:HDL Ratio)   [ Time Frame: Baseline to End Point (up to 6 months) ]

2.  Secondary:

Change From Baseline to End Point in Triglycerides   [ Time Frame: Baseline to End Point (up to 6 months) ]

3.  Secondary:

Change From Baseline to End Point in High Density Lipoprotein   [ Time Frame: Baseline to End Point (up to 6 months) ]

4.  Secondary:

Change From Baseline to End Point in Total Cholesterol   [ Time Frame: Baseline to End Point (up to 6 months) ]

5.  Secondary:

Change From Baseline to End Point in Low Density Lipoprotein Cholesterol (Friedwald QT)   [ Time Frame: Baseline to End Point (up to 6 months) ]

6.  Secondary:

Change From Baseline to End Point in Converted Insulin   [ Time Frame: Baseline to End Point (up to 6 months) ]

7.  Secondary:

Change From Baseline to End Point in Fasting Glucose   [ Time Frame: Baseline to End Point (up to 6 months) ]

8.  Secondary:

Change From Baseline to End Point in Homeostatic Model Assessment of Beta-cell Function (HOMA-%B)   [ Time Frame: Baseline to End Point (up to 6 months) ]

9.  Secondary:

Change From Baseline to End Point in Homeastatic Model Assessment of Insulin Resistance (HOMA-IR)   [ Time Frame: Baseline to End Point (up to 6 months) ]

10.  Secondary:

Number of Patients Meeting the Criteria for Type 2 Diabetes Mellitus During Follow-up   [ Time Frame: 6 months ]

11.  Secondary:

Number of Patients With Onset of Impaired Glucose Tolerance   [ Time Frame: Baseline to End Point (up to 6 months) ]

12.  Secondary:

Number of Patients With Impaired Fasting Glucose   [ Time Frame: Baseline to End Point (up to 6 months) ]

13.  Secondary:

Change From Baseline at End Point of the Insulinogenic Index   [ Time Frame: Baseline to End Point (up to 6 months) ]

14.  Secondary:

Change From Baseline at End Point of Mari-Type Analysis of Glucose Sensitivity for Insulin   [ Time Frame: Baseline to End Point (up to 6 months) ]

15.  Secondary:

Change From Baseline at End Point in Body Weight   [ Time Frame: Baseline to End Point (up to 6 months) ]

16.  Secondary:

Change From Baseline at End Point in Body Mass Index (BMI)   [ Time Frame: Baseline to End Point (up to 6 months) ]

17.  Secondary:

Change From Baseline at End Point in Waist Circumference   [ Time Frame: Baseline to End Point (up to 6 months) ]

18.  Secondary:

Number of Patients First Meeting the NCEP/ATP III Criteria for Metabolic Syndrome During Follow-up   [ Time Frame: 6 months ]

19.  Secondary:

Change From Baseline to End Point in Total Positive and Negative Syndrome Scale Score (PANSS)   [ Time Frame: Baseline to End Point (up to 6 months) ]