Trial Outcomes & Findings for One-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome (NCT NCT00748566)

NCT ID: NCT00748566

Last Updated: 2021-03-03

Results Overview

MS risks factors: elevated (el) waist, men:\>=102 centimeters(cm), women:\>=88 cm (Asian origin:\>=90 cm in men, \>=80 cm in women); el triglycerides: \>=1.7 millimoles per liter (mmol/L) (\>=150 milligram per deciliter \[mg/dL\]); reduced high-density lipoprotein cholesterol (HDL-C), men:\<1.03 mmol/L (\<40 mg/dL), women:\<1.3 mmol/L (\<50 mg/dL); el fasting glucose: \>=5.6 mmol/L (\>=100 mg/dL); el systolic/diastolic blood pressure (SBP/DBP): SBP\>=130 millimeters of mercury (mmHg) and/or DBP\>=85 mmHg. Responder=at least 1 less risk factor at endpoint (premature discontinuation or Week 52) than baseline.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 172 participants
• Primary outcome timeframe: Endpoint (premature discontinuation or Week 52)
• Results posted on: 2021-03-03

Participant Flow

Participant milestones

Measure	Ziprasidone Ziprasidone 40 milligram (mg) capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Overall Study STARTED	172
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	112

Reasons for withdrawal

Measure	Ziprasidone Ziprasidone 40 milligram (mg) capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Overall Study Adverse Event	49
Overall Study Death	1
Overall Study Lack of Efficacy	12
Overall Study Lost to Follow-up	1
Overall Study Protocol Violation	13
Overall Study Withdrawal by Subject	22
Overall Study Study terminated by sponsor	5
Overall Study Other	9

Baseline Characteristics

One-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome

Baseline characteristics by cohort

Measure	Ziprasidone n=172 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Age, Continuous	37.9 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants
Sex: Female, Male Male	120 Participants n=5 Participants

PRIMARY outcome

Timeframe: Endpoint (premature discontinuation or Week 52)

Population: Per protocol (PP) population included all enrolled participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline MS measure, and remained in the study for at least 16 weeks. Missing values were imputed using last observation carried forward (LOCF).

MS risks factors: elevated (el) waist, men:>=102 centimeters(cm), women:>=88 cm (Asian origin:>=90 cm in men, >=80 cm in women); el triglycerides: >=1.7 millimoles per liter (mmol/L) (>=150 milligram per deciliter [mg/dL]); reduced high-density lipoprotein cholesterol (HDL-C), men:<1.03 mmol/L (<40 mg/dL), women:<1.3 mmol/L (<50 mg/dL); el fasting glucose: >=5.6 mmol/L (>=100 mg/dL); el systolic/diastolic blood pressure (SBP/DBP): SBP>=130 millimeters of mercury (mmHg) and/or DBP>=85 mmHg. Responder=at least 1 less risk factor at endpoint (premature discontinuation or Week 52) than baseline.

Outcome measures

Measure	Ziprasidone n=114 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS)	58.77 percentage of participants Interval 47.0 to 71.0

SECONDARY outcome

Timeframe: Baseline, Week 4, 12, 28, 52

Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.

MS risks factors: elevated waist circumference: greater than or equal to (>=)102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): less than (<)1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.

Outcome measures

Measure	Ziprasidone n=114 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52 Baseline (n=114)	3.4 risk factors Standard Deviation 1.0
Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52 Change at Week 4 (n=113)	-0.3 risk factors Standard Deviation 1.0
Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52 Change at Week 12 (n=112)	-0.4 risk factors Standard Deviation 1.1
Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52 Change at Week 28 (n=98)	-0.7 risk factors Standard Deviation 1.3
Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52 Change at Week 52 (n=114)	-0.8 risk factors Standard Deviation 1.2

SECONDARY outcome

Timeframe: Baseline, Week 4, 12, 28, 52

Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.

According to the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATPIII), metabolic syndrome is defined as a condition that includes 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose.

Outcome measures

Measure	Ziprasidone n=114 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Percentage of Participants With Metabolic Syndrome (MS) Baseline (n=114)	79.82 percentage of participants Interval 71.6 to 88.1
Percentage of Participants With Metabolic Syndrome (MS) Week 4 (n=113)	70.80 percentage of participants Interval 60.8 to 80.8
Percentage of Participants With Metabolic Syndrome (MS) Week 12 (n=112)	72.32 percentage of participants Interval 62.6 to 82.1
Percentage of Participants With Metabolic Syndrome (MS) Week 28 (n=98)	58.16 percentage of participants Interval 45.4 to 71.0
Percentage of Participants With Metabolic Syndrome (MS) Week 52 (n=114)	52.63 percentage of participants Interval 40.0 to 65.3

SECONDARY outcome

Timeframe: Week 4, 12, 28, 52

Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.

MS risks factors: elevated waist circumference: >=102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.

Outcome measures

Measure	Ziprasidone n=114 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 Week 4: Decrease by at least 1 risk factor (n=113)	46 participants
Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 Week 4: No change in risk factor (n=113)	46 participants
Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 Week 4: Increase by at least 1 risk factor (n=113)	21 participants
Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 Week 12:Decrease by at least 1 risk factor (n=112)	44 participants
Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 Week 12: No change in risk factor (n=112)	51 participants
Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 Week 12:Increase by at least 1 risk factor (n=112)	17 participants
Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 Week 28: Decrease by at least 1 risk factor (n=98)	45 participants
Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 Week 28: No change in risk factor (n=98)	39 participants
Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 Week 28: Increase by at least 1 risk factor (n=98)	14 participants
Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 Week 52:Decrease by at least 1 risk factor (n=114)	67 participants
Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 Week 52: No change in risk factor (n=114)	35 participants
Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 Week 52:Increase by at least 1 risk factor (n=114)	12 participants

SECONDARY outcome

Timeframe: Baseline, Week 4, 12, 28, 52

Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.

MS risks factors: elevated waist circumference: >=102 cm in men, >=88 cm in women (Asian origin: >=90 cm [men], >=80 cm [women]); elevated triglycerides: >=1.7 mmol/L (>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): <1.03 mmol/L (<40 mg/dL) in men, <1.3 mmol/L (<50 mg/dL) in women; elevated fasting glucose: >=5.6 mmol/L (>=100 mg/dL); elevated SBP/DBP: SBP >=130 mmHg and/or DBP >=85 mmHg.

Outcome measures

Measure	Ziprasidone n=114 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Baseline: Elevated waist circumference (n=114)	93.86 percentage of participants Interval 89.3 to 98.4
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Baseline: Elevated triglycerides (n=114)	83.33 percentage of participants Interval 75.8 to 90.8
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Baseline: Reduced HDL-C (n=114)	78.07 percentage of participants Interval 69.5 to 86.7
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Baseline: Elevated SBP (n=114)	32.46 percentage of participants Interval 17.4 to 47.5
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Baseline: Elevated DBP (n=114)	26.32 percentage of participants Interval 10.6 to 42.1
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Baseline: Elevated fasting glucose (n=114)	44.74 percentage of participants Interval 31.1 to 58.4
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 4: Elevated waist circumference (n=113)	88.50 percentage of participants Interval 82.2 to 94.7
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 4: Elevated triglycerides (n=111)	60.36 percentage of participants Interval 48.6 to 72.1
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 4: Reduced HDL-C (n=113)	71.68 percentage of participants Interval 61.9 to 81.5
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 4: Elevated SBP (n=113)	31.86 percentage of participants Interval 16.6 to 47.1
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 4: Elevated DBP (n=113)	29.20 percentage of participants Interval 13.7 to 44.7
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 4: Elevated fasting glucose (n=113)	46.02 percentage of participants Interval 32.5 to 59.6
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 12: Elevated waist circumference (n=112)	83.93 percentage of participants Interval 76.5 to 91.4
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 12: Elevated triglycerides (n=112)	61.61 percentage of participants Interval 50.1 to 73.1
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 12: Reduced HDL-C (n=112)	72.32 percentage of participants Interval 62.6 to 82.1
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 12: Elevated SBP (n=112)	29.46 percentage of participants Interval 13.9 to 45.0
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 12: Elevated DBP (n=112)	31.25 percentage of participants Interval 15.9 to 46.6
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 12: Elevated fasting glucose (n=112)	36.61 percentage of participants Interval 21.9 to 51.4
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 28: Elevated waist circumference (n=100)	76.00 percentage of participants Interval 66.4 to 85.6
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 28: Elevated triglycerides (n=99)	56.57 percentage of participants Interval 43.6 to 69.5
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 28: Reduced HDL-C (n=99)	61.62 percentage of participants Interval 49.4 to 73.8
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 28: Elevated SBP (n=100)	29.00 percentage of participants Interval 12.5 to 45.5
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 28: Elevated DBP (n=100)	35.00 percentage of participants Interval 19.2 to 50.8
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 28: Elevated fasting glucose (n=99)	37.37 percentage of participants Interval 21.8 to 53.0
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 52: Elevated waist circumference (n=114)	72.81 percentage of participants Interval 63.2 to 82.4
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 52: Elevated triglycerides (n=114)	52.63 percentage of participants Interval 40.0 to 65.3
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 52: Reduced HDL-C (n=114)	63.16 percentage of participants Interval 52.0 to 74.3
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 52: Elevated SBP (n=114)	28.95 percentage of participants Interval 13.5 to 44.4
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 52: Elevated DBP (n=114)	28.95 percentage of participants Interval 13.5 to 44.4
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) Week 52: Elevated fasting glucose (n=114)	32.46 percentage of participants Interval 17.4 to 47.5

SECONDARY outcome

Timeframe: Baseline, Week 4, 12, 28, 52

Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.

Waist circumference data is reported separately for male and female participants.

Outcome measures

Measure	Ziprasidone n=114 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 Baseline: Male (n=79)	110.8 cm Standard Deviation 10.0
Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 Baseline: Female (n=35)	108.9 cm Standard Deviation 10.5
Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 Change at Week 4: Male (n=78)	-1.0 cm Standard Deviation 3.1
Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 Change at Week 4: Female (n=35)	0.4 cm Standard Deviation 3.0
Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 Change at Week 12: Male (n=77)	-2.1 cm Standard Deviation 4.9
Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 Change at Week 12: Female (n=35)	-2.4 cm Standard Deviation 6.8
Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 Change at Week 28: Male (n=70)	-3.7 cm Standard Deviation 7.2
Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 Change at Week 28: Female (n=30)	-2.5 cm Standard Deviation 5.8
Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 Change at Week 52: Male (n=79)	-3.6 cm Standard Deviation 7.5
Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 Change at Week 52: Female (n=35)	-4.0 cm Standard Deviation 8.9

SECONDARY outcome

Timeframe: Baseline, Week 4, 12, 28, 52

Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.

BP measurement is recorded as systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles).

Outcome measures

Measure	Ziprasidone n=114 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 Baseline: SBP (n=114)	124.3 mmHg Standard Deviation 13.3
Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 Baseline: DBP (n=114)	80.7 mmHg Standard Deviation 9.5
Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 Change at Week 4: SBP (n=113)	-1.0 mmHg Standard Deviation 10.0
Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 Change at Week 4: DBP (n=113)	-0.4 mmHg Standard Deviation 7.6
Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 Change at Week 12: SBP (n=112)	-1.0 mmHg Standard Deviation 11.8
Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 Change at Week 12: DBP (n=112)	-0.1 mmHg Standard Deviation 8.0
Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 Change at Week 28: SBP (n=100)	-1.0 mmHg Standard Deviation 11.9
Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 Change at Week 28: DBP (n=100)	0.0 mmHg Standard Deviation 9.5
Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 Change at Week 52: SBP (n=114)	-1.0 mmHg Standard Deviation 11.2
Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 Change at Week 52: DBP (n=114)	-1.1 mmHg Standard Deviation 8.8

SECONDARY outcome

Timeframe: Baseline, Week 4, 12, 28, 52

Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.

Triglyceride data is reported for whole study population whereas HDL-C data is reported separately for male and female participants.

Outcome measures

Measure	Ziprasidone n=114 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 Baseline: HDL-C, Male (n=79)	35.8 mg/dL Standard Deviation 7.2
Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 Baseline: Triglyceride (n=114)	242.8 mg/dL Standard Deviation 115.1
Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 Baseline: HDL-C, Female (n=35)	41.9 mg/dL Standard Deviation 9.0
Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 Change at Week 4: Triglyceride (n=111)	-37.3 mg/dL Standard Deviation 103.8
Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 Change at Week 4: HDL-C, Male (n=78)	1.2 mg/dL Standard Deviation 5.1
Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 Change at Week 4: HDL-C, Female (n=35)	2.1 mg/dL Standard Deviation 7.8
Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 Change at Week 12: Triglyceride (n=112)	-39.5 mg/dL Standard Deviation 93.9
Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 Change at Week 12: HDL-C, Male (n=77)	2.1 mg/dL Standard Deviation 6.0
Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 Change at Week 12: HDL-C, Female (n=35)	1.8 mg/dL Standard Deviation 5.8
Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 Change at Week 28: Triglyceride (n=99)	-52.3 mg/dL Standard Deviation 103.8
Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 Change at Week 28: HDL-C, Male (n=69)	3.1 mg/dL Standard Deviation 5.4
Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 Change at Week 28: HDL-C, Female (n=30)	4.5 mg/dL Standard Deviation 8.0
Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 Change at Week 52: Triglyceride (n=114)	-60.0 mg/dL Standard Deviation 100.7
Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 Change at Week 52: HDL-C, Male (n=79)	3.9 mg/dL Standard Deviation 7.0
Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 Change at Week 52: HDL-C, Female (n=35)	5.0 mg/dL Standard Deviation 8.8

SECONDARY outcome

Timeframe: Baseline, Week 4, 12, 28, 52

Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.

Outcome measures

Measure	Ziprasidone n=114 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52 Baseline (n=114)	104.5 mg/dL Standard Deviation 25.7
Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52 Change at Week 4 (n=113)	-0.8 mg/dL Standard Deviation 19.7
Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52 Change at Week 12 (n=112)	-4.0 mg/dL Standard Deviation 20.3
Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52 Change at Week 28 (n=99)	-5.0 mg/dL Standard Deviation 19.1
Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52 Change at Week 52 (n=114)	-3.0 mg/dL Standard Deviation 31.0

SECONDARY outcome

Timeframe: Baseline, Week 4, 12, 28, 52

Population: PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.

Framingham scoring system risk factors: age (risk points range: -9 to 16), cholesterol (risk points range: 0 to 13), HDL cholesterol (risk points range: -1 to 2), smoking (risk points range: 0 to 9), and systolic blood pressure (risk points range: 0 to 6); total risk points range <0 to >=25, higher score indicates higher CHD risk. The risk points are transformed to 10-year risk percentage for CHD which ranges from <1% to >=30%, where higher percent indicates greater risk for CHD.

Outcome measures

Measure	Ziprasidone n=113 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52 Baseline (n=113)	9.3 percent of 10-year CHD risk Standard Deviation 5.9
Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52 Change at Week 4 (n=112)	-0.7 percent of 10-year CHD risk Standard Deviation 2.5
Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52 Change at Week 12 (n=111)	-0.9 percent of 10-year CHD risk Standard Deviation 2.1
Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52 Change at Week 28 (n=97)	-1.2 percent of 10-year CHD risk Standard Deviation 2.3
Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52 Change at Week 52 (n=113)	-1.3 percent of 10-year CHD risk Standard Deviation 2.4

SECONDARY outcome

Timeframe: Baseline, Week 4, 12, 28, 52

Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.

Outcome measures

Measure	Ziprasidone n=114 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 Baseline: TC (n=114)	5.5 mmol/L Standard Deviation 1.1
Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 Baseline: LDL-C (n=114)	3.3 mmol/L Standard Deviation 1.1
Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 Change at Week 4: TC (n=113)	-0.3 mmol/L Standard Deviation 0.8
Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 Change at Week 4: LDL-C (n=110)	-0.1 mmol/L Standard Deviation 0.8
Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 Change at Week 12: TC (n=112)	-0.4 mmol/L Standard Deviation 0.8
Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 Change at Week 12: LDL-C (n=112)	-0.2 mmol/L Standard Deviation 0.8
Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 Change at Week 28: TC (n=99)	-0.4 mmol/L Standard Deviation 0.8
Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 Change at Week 28: LDL-C (n=97)	-0.2 mmol/L Standard Deviation 0.7
Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 Change at Week 52: TC (n=114)	-0.5 mmol/L Standard Deviation 0.7
Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 Change at Week 52: LDL-C (n=114)	-0.3 mmol/L Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline, Week 4, 12, 28, 52

Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.

Outcome measures

Measure	Ziprasidone n=114 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Change From Baseline in Weight at Week 4,12, 28 and 52 Baseline (n=114)	96.5 kilogram (kg) Standard Deviation 16.9
Change From Baseline in Weight at Week 4,12, 28 and 52 Change at Week 4 (n=113)	-0.9 kilogram (kg) Standard Deviation 3.9
Change From Baseline in Weight at Week 4,12, 28 and 52 Change at Week 12 (n=112)	-2.4 kilogram (kg) Standard Deviation 5.1
Change From Baseline in Weight at Week 4,12, 28 and 52 Change at Week 28 (n=100)	-3.8 kilogram (kg) Standard Deviation 7.4
Change From Baseline in Weight at Week 4,12, 28 and 52 Change at Week 52 (n=114)	-4.4 kilogram (kg) Standard Deviation 8.4

SECONDARY outcome

Timeframe: Baseline, Week 4, 12, 28, 52

Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.

Body mass index calculated as weight in kilograms (kg) divided by height in (meters) squared (m)^2 .

Outcome measures

Measure	Ziprasidone n=114 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52 Baseline (n=114)	32.4 kg/m^2 Standard Deviation 4.3
Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52 Change at Week 4 (n=113)	-0.3 kg/m^2 Standard Deviation 1.2
Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52 Change at Week 12 (n=112)	-0.8 kg/m^2 Standard Deviation 1.6
Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52 Change at Week 28 (n=100)	-1.2 kg/m^2 Standard Deviation 2.3
Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52 Change at Week 52 (n=114)	-1.5 kg/m^2 Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline, Week 4, 12, 28, 52

Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.

Outcome measures

Measure	Ziprasidone n=114 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52 Baseline (n=114)	5.7 percentage of total hemoglobin Standard Deviation 0.8
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52 Change at Week 4 (n=111)	-0.0 percentage of total hemoglobin Standard Deviation 0.2
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52 Change at Week 12 (n=112)	-0.0 percentage of total hemoglobin Standard Deviation 0.3
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52 Change at Week 28 (n=99)	-0.1 percentage of total hemoglobin Standard Deviation 0.4
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52 Change at Week 52 (n=114)	-0.1 percentage of total hemoglobin Standard Deviation 0.4

SECONDARY outcome

Timeframe: Baseline, Week 4, 12, 28, 52

Population: PP population. Missing values were imputed using LOCF at Week 52. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.

Outcome measures

Measure	Ziprasidone n=107 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Change From Baseline in Insulin Level at Week 4, 12, 28 and 52 Baseline (n=107)	22.4 international unit per liter (IU/L) Standard Deviation 27.1
Change From Baseline in Insulin Level at Week 4, 12, 28 and 52 Change at Week 4 (n=102)	-0.3 international unit per liter (IU/L) Standard Deviation 28.9
Change From Baseline in Insulin Level at Week 4, 12, 28 and 52 Change at Week 12 (n=104)	-4.6 international unit per liter (IU/L) Standard Deviation 20.9
Change From Baseline in Insulin Level at Week 4, 12, 28 and 52 Change at Week 28 (n=92)	-7.8 international unit per liter (IU/L) Standard Deviation 23.5
Change From Baseline in Insulin Level at Week 4, 12, 28 and 52 Change at Week 52 (n=107)	-5.6 international unit per liter (IU/L) Standard Deviation 31.0

SECONDARY outcome

Timeframe: Baseline, Week 28, 52

Population: PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Physical activity (exercise) score derived for each participant based on the frequency and intensity of physical activities: regular walking, recreational activity, cycling, and sporting activity. Six categories of total score: inactive (range: 0-2), occasional (range: 3-5), light (range: 6-8), moderate (range: 9-12), moderately vigorous (range: 13-20), and vigorous (>=21). Higher total score = higher frequency and intensity of physical activity.

Outcome measures

Measure	Ziprasidone n=112 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Change From Baseline in the Physical Activity Index Score at Week 28 and 52 Baseline	7.3 units on a scale Standard Deviation 6.8
Change From Baseline in the Physical Activity Index Score at Week 28 and 52 Change at Week 28	0.6 units on a scale Standard Deviation 6.5
Change From Baseline in the Physical Activity Index Score at Week 28 and 52 Change at Week 52	0.5 units on a scale Standard Deviation 6.3

SECONDARY outcome

Timeframe: Baseline, Week 4, 12, 28, 52

Population: Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline MS measure. Missing values at Week 52 were imputed using LOCF. N (number of participants analyzed)=participants evaluable for this measure. n=evaluable participants at specified time points.

QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTc is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds (60 divided by heart rate).

Outcome measures

Measure	Ziprasidone n=56 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52 Baseline (n=56)	413.2 milliseconds Standard Deviation 24.1
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52 Change at Week 4 (n=4)	0.9 milliseconds Standard Deviation 22.0
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52 Change at Week 12 (n=14)	3.4 milliseconds Standard Deviation 27.7
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52 Change at Week 28 (n=38)	6.6 milliseconds Standard Deviation 23.7
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52 Change at Week 52 (n=56)	7.6 milliseconds Standard Deviation 22.8

SECONDARY outcome

Timeframe: Baseline, Week 12, 28, 52

Population: PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.

Assesses positive and negative symptoms, general psychopathology specifically associated with schizophrenia. Scale consists of 30 items, each rated on scale from 1 (symptom not present) - 7 (symptoms extremely severe). Sum of 30 items is defined as PANSS total score, range:30-210. 7 items make up positive scale (delusions, conceptual disorganization, hallucinatory behavior); total range: 7-49. 7 items make up negative scale (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); total range: 7-49. For each subscale, total score: higher score=greater severity.

Outcome measures

Measure	Ziprasidone n=113 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 Baseline: Total Score (n=112)	64.1 units on a scale Standard Deviation 17.8
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 Baseline: Positive Subscale Score (n=113)	13.6 units on a scale Standard Deviation 4.6
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 Baseline: Negative Subscale Score (n=112)	17.9 units on a scale Standard Deviation 6.6
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 Change at Week 12: Total Score (n=110)	-5.7 units on a scale Standard Deviation 11.6
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 Change at Week 12: Positive Subscale Score (n=112)	-1.0 units on a scale Standard Deviation 3.2
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 Change at Week 12: Negative Subscale Score (n=111)	-1.9 units on a scale Standard Deviation 4.5
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 Change at Week 28: Total Score (n=98)	-4.4 units on a scale Standard Deviation 14.3
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 Change at Week 28: Positive Subscale Score (n=100)	-0.9 units on a scale Standard Deviation 4.5
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 Change at Week 28: Negative Subscale Score (n=98)	-1.6 units on a scale Standard Deviation 5.3
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 Change at Week 52: Total Score (n=112)	-3.2 units on a scale Standard Deviation 17.0
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 Change at Week 52: Positive Subscale Score (n=113)	-0.2 units on a scale Standard Deviation 5.6
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 Change at Week 52: Negative Subscale Score (n=112)	-1.7 units on a scale Standard Deviation 5.5

SECONDARY outcome

Timeframe: Baseline, Week 12, 28, 52

Population: PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.

CGI-S is a single-item, clinician-rated scale that assesses the global severity of the participants overall illness. CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill participants).

Outcome measures

Measure	Ziprasidone n=113 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52 Baseline (n=113)	3.3 units on a scale Standard Deviation 0.9
Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52 Change at Week 12 (n=112)	-0.3 units on a scale Standard Deviation 0.7
Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52 Change at Week 28 (n=100)	-0.2 units on a scale Standard Deviation 0.8
Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52 Change at Week 52 (n=113)	-0.2 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Endpoint (premature discontinuation or Week 52)

Population: PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

CGI-I is a single-item, clinician-rated scale that assesses global improvement in the participants clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 to 7, where 1=very much improved, 4=no change and 7=very much worse.

Outcome measures

Measure	Ziprasidone n=107 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Clinical Global Impression-Improvement (CGI-I) Scale Score	3.2 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: Baseline, Week 28, 52

Population: PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.

DAI, a 30-item scale measuring subjective responses to medication (including acceptability and tolerability which aims to understand the factors influencing treatment adherence). Scale has 15 items (statements) scored as true and 15 items scored as false. An overall calculated score ranged from -15 to 15, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance.

Outcome measures

Measure	Ziprasidone n=105 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Change From Baseline in Drug-Attitude Inventory-30-Item Scale (DAI-30) Score at Week 28 and 52 Baseline (n=105)	-1.3 units on a scale Standard Deviation 5.8
Change From Baseline in Drug-Attitude Inventory-30-Item Scale (DAI-30) Score at Week 28 and 52 Change at Week 28 (n=104)	0.4 units on a scale Standard Deviation 6.5
Change From Baseline in Drug-Attitude Inventory-30-Item Scale (DAI-30) Score at Week 28 and 52 Change at Week 52 (n=105)	-0.1 units on a scale Standard Deviation 6.1

SECONDARY outcome

Timeframe: Baseline, Week 28, 52

Population: PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

SOFAS: a 0-100 single score scale focusing exclusively on participant's level of social and occupational functioning; not directly influenced by overall severity of participant's psychological symptoms; higher score = higher level of functioning.

Outcome measures

Measure	Ziprasidone n=111 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52 Baseline	57.2 units on a scale Standard Deviation 11.5
Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52 Change at Week 28	1.6 units on a scale Standard Deviation 11.3
Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52 Change at Week 52	1.1 units on a scale Standard Deviation 11.4

SECONDARY outcome

Timeframe: Baseline, Week 28, 52

Population: PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Outcome measures

Measure	Ziprasidone n=111 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Change From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Index (EQ-I) Score at Week 28 and 52 Baseline	0.8 units on a scale Standard Deviation 0.3
Change From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Index (EQ-I) Score at Week 28 and 52 Change at Week 28	0.0 units on a scale Standard Deviation 0.2
Change From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Index (EQ-I) Score at Week 28 and 52 Change at Week 52	0.0 units on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: Baseline, Week 28, 52

Population: PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

Outcome measures

Measure	Ziprasidone n=112 Participants Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Changes From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52 Baseline (n=112)	58.8 units on a scale Standard Deviation 27.4
Changes From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52 Change at Week 28 (n=111)	4.7 units on a scale Standard Deviation 30.5
Changes From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52 Change at Week 52 (n=112)	5.7 units on a scale Standard Deviation 30.4

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52

Population: Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.

C-SSRS assessed whether participant experienced following: completed suicide(1), suicide attempt(2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior(3)("Yes" on "preparatory acts or behavior"), suicidal ideation(4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act/some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior(7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior").

Outcome measures

Outcome data not reported

Adverse Events

Ziprasidone

Serious events: 20 serious events

Other events: 122 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ziprasidone n=172 participants at risk Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Infections and infestations Appendicitis	0.58% 1/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sepsis	0.58% 1/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Overdose	0.58% 1/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.58% 1/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Convulsion	0.58% 1/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Sedation	0.58% 1/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Adjustment disorder with mixed anxiety and depressed mood	0.58% 1/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Agitation	0.58% 1/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Attention-seeking behaviour	0.58% 1/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depressed mood	0.58% 1/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depression	0.58% 1/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Hallucinations, mixed	0.58% 1/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Psychotic disorder	1.7% 3/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Schizophrenia	2.9% 5/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Suicidal ideation	0.58% 1/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Suicide attempt	0.58% 1/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Measure	Ziprasidone n=172 participants at risk Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365.
Gastrointestinal disorders Diarrhoea	6.4% 11/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	16.3% 28/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	6.4% 11/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	12.2% 21/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	7.6% 13/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Akathisia	6.4% 11/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	8.7% 15/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	12.8% 22/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Somnolence	9.9% 17/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Anxiety	19.2% 33/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depression	5.2% 9/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Insomnia	29.1% 50/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Restlessness	5.8% 10/172 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER