Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00406315
• Collaborator: (none)
• Enrollment: 255
• Locations: 40
• Arm: 1
• Duration (Months): 28
• Patients Per Site: 6.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate change in weight as a result of switching from quetiapine to ziprasidone, in subjects with schizophrenia or schizoaffective disorder who have failed to achieve a satisfactory clinical response to quetiapine due to lack of efficacy or poor tolerability.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia; Schizoaffective Disorder	Drug: ziprasidone	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 255 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Sixteen-Week, Multi-Center, Open-Label Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone In Subjects Diagnosed With Schizophrenia Or Schizoaffective Disorder
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: A1 atypical antipsychotic for the treatment of schizophrenia	Drug: ziprasidone; Days 1-3: 40 mg twice a day (BID); Days 4-7: 60 mg BID; Day 8: 80 mg BID; Flexible dose between 40-80 mg BID (adjustable up to 40 mg daily/week) for the remainder of the 16-week treatment phase and continuing throughout the 16-week follow-up phase; Other Names: Geodon, Zeldox

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Weight at Week 16 [Baseline, Week 16, Week 16 LOCF]

   Weight value: Change = value at Week 16 or Week 16 Last Observation Carried Forward (LOCF) minus value at Baseline.

Secondary Outcome Measures

1. Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16 [Baseline, Week 16]

   Total cholesterol value: Change = value at Week 16 minus value at Baseline.

2. Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16 [Baseline, Week 16]

   HDL, LDL, and triglyceride value: Change = value at Week 16 minus value at Baseline.

3. Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16 [Baseline, Week 16]

   HbAlc value: Change = value at Week 16 minus value at Baseline.

4. Change From Baseline in Fasting Glucose at Week 16 [Baseline, Week 16]

   Fasting glucose value: Change = value at Week 16 minus value at Baseline.

5. Change From Baseline in Fasting Insulin at Week 16 [Baseline, Week 16]

   Fasting insulin value: Change = value at Week 16 minus value at Baseline.

6. Change From Baseline in Waist and Hip Circumference at Week 16 [Baseline, Week 16]

   Waist and hip circumference value: Change = value at Week 16 minus value at Baseline.

7. Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16 [Baseline, Week 16]

   AIMS: a 12-item clinician administered instrument assessing observed abnormal movements in different parts of body. Ten items scored on a 5-point scale (0 = none/normal, 4 = severe) evaluate abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42. Item 8 indicates severity, item 9 indicates Incapacitation. AIMS total, global severity, or global incapacitation score: Change = score at Week 16 minus score at Baseline.

8. Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16 [Baseline, Week 16, Week 16 LOCF]

   PANSS measures severity of psychopathology in subjects with schizophrenia, schizoaffective disorder and other psychotic disorders. It includes 3 scales and a total of 30 items: 7 items comprise the positive scale, 7 comprise the negative scale, and 16 items measure general psychopathology. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210. PANSS total score and positive and negative scores: Change = score at Week 16 or Week 16 LOCF minus score at Baseline.

9. Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16 [Baseline, Week 16, Week 16 LOCF]

   The CGI-S is a single item, clinician-rated scale that assesses the global severity of the subject's overall illness. The CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). CGI-S score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.

10. Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16 [Week 16, Week 16 LOCF]

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

11. Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16 [Baseline, Week 16, Week 16 LOCF]

    The CDSS is a 9-item, clinician-rated scale validated for rating the severity of depressive symptoms in subjects diagnosed with schizophrenia, and independent of confounding negative and extrapyramidal symptoms. The CDSS rates the severity of depressive symptoms on a 4-point scale ranging from 0 (absent) to 3 (severe). The CDSS depression total score is obtained by adding each of the item scores. Total possible score ranges from 0 to 27. CDSS possible total score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.

12. Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16 [Baseline, Week 16, Week 16 LOCF]

    The SCoRS is a 20-question rating scale completed via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. Each question was completed using a 4-point scale (ranging from 1=none to 4=severe). Total possible score ranged from 20 to 80. At the end of the 20 questions, the interviewer completed a Global Scale of 1-10, rating subject's overall difficulty. Higher scores on both indicated greater cognitive impairment. SCoRS total score and global rating: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.

13. Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16 [Baseline, Week 16, Week 16 LOCF]

    GAF Scale measures the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale. Total possible score ranges from 0 (not enough information available to provide GAF) to 100 (Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many qualities. No symptoms). The assessment was done by a trained assessor. GAF scale score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.

14. Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16 [Baseline, Week 16, Week 16 LOCF]

    The TSQM is a 13-item subject-rated scale that evaluates the effectiveness, side effects and convenience of the medication over the past 2-3 weeks. Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100. TSQM Effectivenss, Side Effect, Convenience, and Global Satisfaction scores: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males or females, between 18 and 55 years of age, at the time of consent.

• Subjects must have a primary diagnosis of schizophrenia, any subtype (code 295.xx), or schizoaffective disorder as defined in DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition)

• Subjects must have normal vital signs, physical examination, ECG, and laboratory findings except for minor deviations determined and documented to be clinically insignificant by the investigator or a sub-investigator who is a medical doctor.

Exclusion Criteria:

• Subjects who are unable to provide informed consent

• Subjects who meet criteria for a DSM-IV-TR Axis I (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition) diagnosis other than schizophrenia or schizoaffective disorder, including psychoactive substance abuse or dependence within one year of study entry

• Females who are pregnant, breast feeding, or lactating at screening.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Phoenix	Arizona	United States	85028
2	Pfizer Investigational Site	Costa Mesa	California	United States	92626
3	Pfizer Investigational Site	Garden Grove	California	United States	92845
4	Pfizer Investigational Site	National City	California	United States	91950
5	Pfizer Investigational Site	Orange	California	United States	92868-8040
6	Pfizer Investigational Site	San Diego	California	United States	92123
7	Pfizer Investigational Site	Temecula	California	United States	92591
8	Pfizer Investigational Site	Torrance	California	United States	90505
9	Pfizer Investigational Site	Hialeah	Florida	United States	33016
10	Pfizer Investigational Site	Miami	Florida	United States	33126
11	Pfizer Investigational Site	Miami	Florida	United States	33143
12	Pfizer Investigational Site	Chicago	Illinois	United States	60640
13	Pfizer Investigational Site	Des Plaines	Illinois	United States	60016
14	Pfizer Investigational Site	Oakbrook Terrace	Illinois	United States	60181
15	Pfizer Investigational Site	Schaumburg	Illinois	United States	60194
16	Pfizer Investigational Site	Topeka	Kansas	United States	66606
17	Pfizer Investigational Site	Olive Branch	Mississippi	United States	38654
18	Pfizer Investigational Site	Saint Louis	Missouri	United States	63368
19	Pfizer Investigational Site	Las Vegas	Nevada	United States	89102
20	Pfizer Investigational Site	Nashua	New Hampshire	United States	03060
21	Pfizer Investigational Site	Olean	New York	United States	14760
22	Pfizer Investigational Site	Staten Island	New York	United States	10312
23	Pfizer Investigational Site	Memphis	Tennessee	United States	38117
24	Pfizer Investigational Site	Memphis	Tennessee	United States	38133
25	Pfizer Investigational Site	Dallas	Texas	United States	75231
26	Pfizer Investigational Site	DeSoto	Texas	United States	75115
27	Pfizer Investigational Site	Bothell	Washington	United States	98011
28	Pfizer Investigational Site	Kirkland	Washington	United States	98033
29	Pfizer Investigational Site	Aparecida de Goiânia	GO	Brazil	74922-810
30	Pfizer Investigational Site	Rio de Janeiro	RJ	Brazil	22290-140
31	Pfizer Investigational Site	São Paulo	SP	Brazil	05403-010
32	Pfizer Investigational Site	Berlin		Germany	10117
33	Pfizer Investigational Site	Duesseldorf		Germany	40629
34	Pfizer Investigational Site	Hamburg		Germany	20246
35	Pfizer Investigational Site	Muenchen		Germany	80336
36	Pfizer Investigational Site	Athens		Greece	10676
37	Pfizer Investigational Site	Thessaloniki		Greece	546 42
38	Pfizer Investigational Site	Zamora		Spain	49021
39	Pfizer Investigational Site	Ankara		Turkey	06200
40	Pfizer Investigational Site	Izmit		Turkey	41380

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00406315
• Other Study ID Numbers: A1281148
• First Posted: Dec 4, 2006
• Last Update Posted: Mar 29, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: ziprasidone, quetiapine (Seroquel) switch, open label, flexible dose, schizophrenia, schizoaffective disorder
• Additional relevant MeSH terms: Schizophrenia; Psychotic Disorders; Ziprasidone

Study Results

Participant Flow

Pre-assignment Detail	An additional 14 subjects had a baseline visit but were never treated.

Arm/Group Title	Ziprasidone
Arm/Group Description	For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
Period Title: Overall Study
STARTED	241
COMPLETED	100
NOT COMPLETED	141

Baseline Characteristics

Arm/Group Title	Ziprasidone
Arm/Group Description	For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
Overall Participants	241
Age, Customized (participants) [Number]
< 18 years	0 0%
18 to 44 years	140 58.1%
45 to 64 years	101 41.9%
> = 65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	111 46.1%
Male	130 53.9%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Weight at Week 16
Description	Weight value: Change = value at Week 16 or Week 16 Last Observation Carried Forward (LOCF) minus value at Baseline.
Time Frame	Baseline, Week 16, Week 16 LOCF

Outcome Measure Data

Analysis Population Description

Safety population = all enrolled subjects who took at least 1 dose of study medication. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.

Arm/Group Title	Ziprasidone
Arm/Group Description	For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
Measure Participants	231
Week 16 (n=133)	-1.09 (3.918)
Week 16 LOCF (n=231)	-0.73 (3.725)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Week 16.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	One-sided upper confidence limit
	Estimated Value	-0.53
	Confidence Interval	(1-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	A one-sided 95% confidence interval (CI) was constructed for the mean weight change from baseline to infer whether there was a significant decrease in weight.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Week 16 LOCF. Based on past information, the standard deviation of the mean weight difference was expected to be 2.2. The sample size of the study was estimated so that the one-sided CI of the mean weight decrease has a certain width. To obtain a one-sided CI with a width of 0.27 kg, a sample size of 180 subjects was needed. In other words, we were 95% certain that the true mean weight decrease was in an interval starting from the observed weight decrease and extending 0.27 kg unit above it.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	One-sided upper confidence limit
	Estimated Value	-0.33
	Confidence Interval	(1-Sided) 95%; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	A one-sided 95% CI was constructed for the mean weight change from baseline to infer whether there was a significant decrease in weight.

2. Secondary Outcome

Title	Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16
Description	Total cholesterol value: Change = value at Week 16 minus value at Baseline.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

Safety population.

Arm/Group Title	Ziprasidone
Arm/Group Description	For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
Measure Participants	128
Mean (Standard Deviation) [milligram (mg)/deciliter (dL)]	-3.0 (31.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -8.48 to 2.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16
Description	HDL, LDL, and triglyceride value: Change = value at Week 16 minus value at Baseline.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

Safety population.

Arm/Group Title	Ziprasidone
Arm/Group Description	For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
Measure Participants	128
HDL (n=128)	-0.2 (9.32)
LDL (n=123)	-2.5 (25.66)
Triglycerides (n=128)	-1.6 (84.58)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	HDL. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	-0.2
	Confidence Interval	(2-Sided) 95%; -1.82 to 1.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	LDL. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	-2.5
	Confidence Interval	(2-Sided) 95%; -7.07 to 2.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Triglycerides. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	-1.6
	Confidence Interval	(2-Sided) 95%; -16.44 to 13.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16
Description	HbAlc value: Change = value at Week 16 minus value at Baseline.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

Safety population.

Arm/Group Title	Ziprasidone
Arm/Group Description	For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
Measure Participants	127
Mean (Standard Deviation) [percent]	0.1 (0.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -0.02 to 0.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Change From Baseline in Fasting Glucose at Week 16
Description	Fasting glucose value: Change = value at Week 16 minus value at Baseline.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

Safety population.

Arm/Group Title	Ziprasidone
Arm/Group Description	For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
Measure Participants	128
Mean (Standard Deviation) [mg/dL]	3.0 (17.84)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	3.0
	Confidence Interval	(2-Sided) 95%; -0.09 to 6.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Change From Baseline in Fasting Insulin at Week 16
Description	Fasting insulin value: Change = value at Week 16 minus value at Baseline.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

Safety population.

Arm/Group Title	Ziprasidone
Arm/Group Description	For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
Measure Participants	118
Mean (Standard Deviation) [microinternational (mciu)/milliliter(mL)]	134.8 (851.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	134.8
	Confidence Interval	(2-Sided) 95%; -20.43 to 289.98
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Change From Baseline in Waist and Hip Circumference at Week 16
Description	Waist and hip circumference value: Change = value at Week 16 minus value at Baseline.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

Safety population.

Arm/Group Title	Ziprasidone
Arm/Group Description	For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
Measure Participants	132
Waist (n=132)	-2.9 (17.53)
Hip (n=131)	-3.0 (18.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Waist. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	-2.9
	Confidence Interval	(2-Sided) 95%; -5.93 to 0.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Hip. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -6.20 to 0.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16
Description	AIMS: a 12-item clinician administered instrument assessing observed abnormal movements in different parts of body. Ten items scored on a 5-point scale (0 = none/normal, 4 = severe) evaluate abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42. Item 8 indicates severity, item 9 indicates Incapacitation. AIMS total, global severity, or global incapacitation score: Change = score at Week 16 minus score at Baseline.
Time Frame	Baseline, Week 16

Outcome Measure Data

Analysis Population Description

Safety population.

Arm/Group Title	Ziprasidone
Arm/Group Description	For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
Measure Participants	144
AIMS Total Score	0.05 (2.251)
AIMS Global Severity Score	0.03 (0.472)
AIMS Global Incapacitation Score	0.01 (0.383)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Total Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 95%; -0.32 to 0.42
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Global Severity Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 95%; -0.05 to 0.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Global Incapacitation Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 95%; -0.06 to 0.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16
Description	PANSS measures severity of psychopathology in subjects with schizophrenia, schizoaffective disorder and other psychotic disorders. It includes 3 scales and a total of 30 items: 7 items comprise the positive scale, 7 comprise the negative scale, and 16 items measure general psychopathology. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210. PANSS total score and positive and negative scores: Change = score at Week 16 or Week 16 LOCF minus score at Baseline.
Time Frame	Baseline, Week 16, Week 16 LOCF

Outcome Measure Data

Analysis Population Description

Intent-to-treat population (ITT) = all enrolled subjects with baseline and at least 1 post baseline efficacy evaluation. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.

Arm/Group Title	Ziprasidone
Arm/Group Description	For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
Measure Participants	231
Total Score, Week 16 (n=144)	-10.22 (15.027)
Total Score, Week 16 LOCF (n=231)	-6.61 (15.306)
Positive Subscale Score, Week 16 (n=144)	-3.30 (4.658)
Positive Subscale Score, Week 16 LOCF (n=231)	-2.43 (4.634)
Negative Subscale Score, Week 16 (n=144)	-1.67 (4.147)
Negative Subscale Score, Week 16 LOCF (n=231)	-0.92 (4.373)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Total Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	-10.22
	Confidence Interval	(2-Sided) 95%; -12.70 to -7.75
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Total Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	-6.61
	Confidence Interval	(2-Sided) 95%; -8.59 to -4.63
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Positive Subscale Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	-3.30
	Confidence Interval	(2-Sided) 95%; -4.07 to -2.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Positive Subscale Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	-2.43
	Confidence Interval	(2-Sided) 95%; -3.03 to -1.83
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Negative Subscale Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	-1.67
	Confidence Interval	(2-Sided) 95%; -2.36 to -0.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Negative Subscale Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	-0.92
	Confidence Interval	(2-Sided) 95%; -1.48 to -0.35
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16
Description	The CGI-S is a single item, clinician-rated scale that assesses the global severity of the subject's overall illness. The CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). CGI-S score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Time Frame	Baseline, Week 16, Week 16 LOCF

Outcome Measure Data

Analysis Population Description

ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.

Arm/Group Title	Ziprasidone
Arm/Group Description	For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
Measure Participants	231
Week 16 (n=135)	-0.76 (0.868)
Week 16 LOCF (n=231)	-0.47 (0.848)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	-0.76
	Confidence Interval	(2-Sided) 95%; -0.90 to -0.61
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	-0.47
	Confidence Interval	(2-Sided) 95%; -0.58 to -0.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16
Description	The CGI-I is a 7-point, single-item, clinician-rated scale that assesses global improvement in the subject's clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse).
Time Frame	Week 16, Week 16 LOCF

Outcome Measure Data

Analysis Population Description

ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.

Arm/Group Title	Ziprasidone
Arm/Group Description	For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
Measure Participants	231
Week 16 (n=135)	2.7 (1.05)
Week 16 LOCF (n=231)	3.2 (1.22)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	2.7
	Confidence Interval	(2-Sided) 95%; 2.52 to 2.88
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	3.2
	Confidence Interval	(2-Sided) 95%; 3.02 to 3.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16
Description	The CDSS is a 9-item, clinician-rated scale validated for rating the severity of depressive symptoms in subjects diagnosed with schizophrenia, and independent of confounding negative and extrapyramidal symptoms. The CDSS rates the severity of depressive symptoms on a 4-point scale ranging from 0 (absent) to 3 (severe). The CDSS depression total score is obtained by adding each of the item scores. Total possible score ranges from 0 to 27. CDSS possible total score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Time Frame	Baseline, Week 16, Week 16 LOCF

Outcome Measure Data

Analysis Population Description

ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.

Arm/Group Title	Ziprasidone
Arm/Group Description	For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
Measure Participants	231
Week 16 (n=144)	-2.55 (4.364)
Week 16 LOCF (n=231)	-1.58 (4.526)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	-2.55
	Confidence Interval	(2-Sided) 95%; -3.27 to -1.83
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	-1.58
	Confidence Interval	(2-Sided) 95%; -2.16 to -0.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16
Description	The SCoRS is a 20-question rating scale completed via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. Each question was completed using a 4-point scale (ranging from 1=none to 4=severe). Total possible score ranged from 20 to 80. At the end of the 20 questions, the interviewer completed a Global Scale of 1-10, rating subject's overall difficulty. Higher scores on both indicated greater cognitive impairment. SCoRS total score and global rating: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Time Frame	Baseline, Week 16, Week 16 LOCF

Outcome Measure Data

Analysis Population Description

ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.

Arm/Group Title	Ziprasidone
Arm/Group Description	For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
Measure Participants	169
Total Score, Week 16 (n=137)	-4.61 (7.981)
Total Score, Week 16 LOCF (n=169)	-4.21 (8.961)
Global Rating, Week 16 (n=137)	-1.02 (1.708)
Global Rating, Week 16 LOCF (n=169)	-0.88 (1.643)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Total Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	-4.61
	Confidence Interval	(2-Sided) 95%; -5.95 to -3.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Total Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	-4.21
	Confidence Interval	(2-Sided) 95%; -5.57 to -2.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Global Rating, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	-1.02
	Confidence Interval	(2-Sided) 95%; -1.31 to -0.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Global Rating, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	-0.88
	Confidence Interval	(2-Sided) 95%; -1.13 to -0.63
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16
Description	GAF Scale measures the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale. Total possible score ranges from 0 (not enough information available to provide GAF) to 100 (Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many qualities. No symptoms). The assessment was done by a trained assessor. GAF scale score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Time Frame	Baseline, Week 16, Week 16 LOCF

Outcome Measure Data

Analysis Population Description

ITT. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.

Arm/Group Title	Ziprasidone
Arm/Group Description	For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
Measure Participants	230
Week 16 (n=145)	7.88 (11.029)
Week 16 LOCF (n=230)	5.27 (10.626)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	7.88
	Confidence Interval	(2-Sided) 95%; 6.07 to 9.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	5.27
	Confidence Interval	(2-Sided) 95%; 3.89 to 6.65
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16
Description	The TSQM is a 13-item subject-rated scale that evaluates the effectiveness, side effects and convenience of the medication over the past 2-3 weeks. Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100. TSQM Effectivenss, Side Effect, Convenience, and Global Satisfaction scores: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Time Frame	Baseline, Week 16, Week 16 LOCF

Outcome Measure Data

Analysis Population Description

ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.

Arm/Group Title	Ziprasidone
Arm/Group Description	For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
Measure Participants	180
Effectiveness, Week 16 (n=178)	10.49 (30.662)
Effectiveness, Week 16 LOCF (n=178)	10.49 (30.662)
Side Effect, Week 16 (n=167)	18.49 (42.883)
Side Effect, Week 16 LOCF (n=167)	18.49 (42.883)
Convenience, Week 16 (n=180)	6.45 (23.630)
Convenience, Week 16 LOCF (n=180)	6.45 (23.630)
Global Satisfaction, Week 16 (n=179)	15.32 (36.304)
Global Satisfaction, Week 16 LOCF (n=179)	15.32 (36.304)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Effectiveness, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	10.49
	Confidence Interval	(2-Sided) 95%; 5.95 to 15.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Effectiveness, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	10.49
	Confidence Interval	(2-Sided) 95%; 5.95 to 15.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Side Effect, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	18.49
	Confidence Interval	(2-Sided) 95%; 11.94 to 25.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Side Effect, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	18.49
	Confidence Interval	(2-Sided) 95%; 11.94 to 25.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Convenience, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	6.45
	Confidence Interval	(2-Sided) 95%; 2.98 to 9.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Convenience, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	6.45
	Confidence Interval	(2-Sided) 95%; 2.98 to 9.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Global Satisfaction, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	15.32
	Confidence Interval	(2-Sided) 95%; 9.97 to 20.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Ziprasidone
	Comments	Global Satisfaction, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean
	Estimated Value	15.32
	Confidence Interval	(2-Sided) 95%; 9.97 to 20.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Ziprasidone
Arm/Group Description	For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
All Cause Mortality
	Ziprasidone
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Ziprasidone
	Affected / at Risk (%)	# Events
Total	22/241 (9.1%)
Blood and lymphatic system disorders
Anaemia	1/241 (0.4%)
Infections and infestations
Lung infection	1/241 (0.4%)
Nervous system disorders
Dystonia	1/241 (0.4%)
Psychiatric disorders
Aggression	1/241 (0.4%)
Delusion of grandeur	1/241 (0.4%)
Depression	2/241 (0.8%)
Hallucination, auditory	1/241 (0.4%)
Insomnia	1/241 (0.4%)
Mental disorder	1/241 (0.4%)
Psychotic disorder	3/241 (1.2%)
Schizoaffective disorder	4/241 (1.7%)
Schizophrenia	4/241 (1.7%)
Self injurious behaviour	1/241 (0.4%)
Suicidal ideation	2/241 (0.8%)
Suicide attempt	2/241 (0.8%)
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic	1/241 (0.4%)
Pharyngeal polyp	1/241 (0.4%)
Other (Not Including Serious) Adverse Events
	Ziprasidone
	Affected / at Risk (%)	# Events
Total	124/241 (51.5%)
Gastrointestinal disorders
Nausea	28/241 (11.6%)
Vomiting	16/241 (6.6%)
Metabolism and nutrition disorders
Decreased appetite	12/241 (5%)
Nervous system disorders
Akathisia	15/241 (6.2%)
Dizziness	13/241 (5.4%)
Headache	24/241 (10%)
Sedation	17/241 (7.1%)
Somnolence	35/241 (14.5%)
Psychiatric disorders
Anxiety	15/241 (6.2%)
Insomnia	46/241 (19.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.