Trial Outcomes & Findings for Treatment of Schizophrenic Patients With Ziprasidone (NCT NCT00579670)

Results Overview

Stage, symptoms and type of schizophrenia were recorded in addition to demographic and other clinical history data at the Baseline visit. The primary outcome was to assess the participants profile. Some assessments have been included in the Baseline demographics. This outcome presents results for the Summary of Schizophrenia.

Recruitment status

COMPLETED

Target enrollment

450 participants

Primary outcome timeframe

Baseline

Results posted on

2021-03-10

Participant Flow

The use and dosage of ziprasidone for this Non-interventional Post-Marketing Surveillance study was based on the approved summary of product characteristics (SmPC) document and adjusted solely according to medical and therapeutic necessity.

Participant milestones

Participant milestones
Measure	Ziprasidone < 80 mg Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg Ziprasidone between 80 mg and \< 120 mg per day.	Ziprasidone 120 mg to < 160 mg Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown Details are unknown.
Overall Study STARTED	15	57	88	285	5
Overall Study Population: Within SmPC (Started)	15	56	83	159	0
Overall Study Population: Within SmPC (Completed)	13	55	79	147	0
Overall Study COMPLETED	13	56	84	263	5
Overall Study NOT COMPLETED	2	1	4	22	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Ziprasidone < 80 mg Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg Ziprasidone between 80 mg and \< 120 mg per day.	Ziprasidone 120 mg to < 160 mg Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg Ziprasidone 160 mg or greater per day.
Overall Study Death	1	0	0	0
Overall Study Adverse Event	1	0	1	2
Overall Study Lack of Efficacy	0	0	1	14
Overall Study Lost to Follow-up	0	1	0	4
Overall Study Other	0	0	1	2
Overall Study Withdrawal by Subject	0	0	1	0

Baseline Characteristics

Treatment of Schizophrenic Patients With Ziprasidone

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Total n=450 Participants Total of all reporting groups
Age, Customized < 18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Age, Customized 18 years through 44 years	3 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants	169 Participants n=4 Participants	2 Participants n=21 Participants	238 Participants n=10 Participants
Age, Customized 45 years through 64 years	4 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants	96 Participants n=4 Participants	2 Participants n=21 Participants	157 Participants n=10 Participants
Age, Customized >= 65 years	8 Participants n=5 Participants	16 Participants n=7 Participants	9 Participants n=5 Participants	20 Participants n=4 Participants	1 Participants n=21 Participants	54 Participants n=10 Participants
Sex/Gender, Customized Male	9 Participants n=5 Participants	35 Participants n=7 Participants	42 Participants n=5 Participants	173 Participants n=4 Participants	3 Participants n=21 Participants	262 Participants n=10 Participants
Sex/Gender, Customized Female	6 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants	110 Participants n=4 Participants	2 Participants n=21 Participants	185 Participants n=10 Participants
Sex/Gender, Customized Unspecified	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants
Schizophrenia Duration	33.9 Years n=5 Participants	21.4 Years n=7 Participants	16.9 Years n=5 Participants	12.8 Years n=4 Participants	15.6 Years n=21 Participants	15.4 Years n=10 Participants

PRIMARY outcome

Timeframe: Baseline

Population: All subjects randomized to a treatment group were included in the Baseline analysis.

Stage, symptoms and type of schizophrenia were recorded in addition to demographic and other clinical history data at the Baseline visit. The primary outcome was to assess the participants profile. Some assessments have been included in the Baseline demographics. This outcome presents results for the Summary of Schizophrenia.

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Summary of Schizophrenia Type: Schizoaffective disorder	14 Participants	35 Participants	1 Participants	3 Participants	15 Participants
Summary of Schizophrenia Type: Schizophrenia not otherwise specified (NOS)	2 Participants	5 Participants	0 Participants	0 Participants	2 Participants
Summary of Schizophrenia Stage: First episode	9 Participants	39 Participants	0 Participants	1 Participants	5 Participants
Summary of Schizophrenia Stage: Acute exacerbation	12 Participants	89 Participants	2 Participants	1 Participants	2 Participants
Summary of Schizophrenia Stage: Chronic, stable	54 Participants	117 Participants	3 Participants	12 Participants	46 Participants
Summary of Schizophrenia Stage: Refractory	13 Participants	40 Participants	0 Participants	1 Participants	4 Participants
Summary of Schizophrenia Symptoms: Positive	47 Participants	191 Participants	3 Participants	2 Participants	29 Participants
Summary of Schizophrenia Symptoms: Negative	16 Participants	49 Participants	0 Participants	6 Participants	13 Participants
Summary of Schizophrenia Symptoms: Depressive	9 Participants	12 Participants	0 Participants	1 Participants	9 Participants
Summary of Schizophrenia Symptoms: No predominant symptomatology	16 Participants	32 Participants	2 Participants	6 Participants	6 Participants
Summary of Schizophrenia Type: Catatonic	0 Participants	7 Participants	0 Participants	1 Participants	0 Participants
Summary of Schizophrenia Type: Disorganized	5 Participants	30 Participants	0 Participants	0 Participants	0 Participants
Summary of Schizophrenia Type: Paranoid	43 Participants	148 Participants	3 Participants	2 Participants	22 Participants
Summary of Schizophrenia Type: Residual	14 Participants	30 Participants	1 Participants	7 Participants	13 Participants
Summary of Schizophrenia Type: Undifferentiated	10 Participants	30 Participants	0 Participants	2 Participants	5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: All subjects randomized to a treatment group were included in this baseline analysis.

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown Details are unknown.	Ziprasidone < 80 mg n=450 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg Ziprasidone between 80 mg and \< 120 mg per day.
Summary of Metabolic Risk Factors No metabolic risk factors at Baseline	—	—	—	205 Participants	—
Summary of Metabolic Risk Factors ≥1 metabolic risk factors at Baseline	—	—	—	245 Participants	—
Summary of Metabolic Risk Factors 1 metabolic risk factor at Baseline	—	—	—	133 Participants	—
Summary of Metabolic Risk Factors 2 metabolic risk factors at Baseline	—	—	—	64 Participants	—
Summary of Metabolic Risk Factors ≥3 metabolic risk factors at Baseline	—	—	—	48 Participants	—
Summary of Metabolic Risk Factors Fasting glucose level (≥110 mg/dL)	—	—	—	48 Participants	—
Summary of Metabolic Risk Factors Triglycerides (≥150 mg/dL)	—	—	—	76 Participants	—
Summary of Metabolic Risk Factors HDL (men <40 mg/dL; women <50 mg/dL)	—	—	—	77 Participants	—
Summary of Metabolic Risk Factors Blood pressure (≥130/85 mm Hg)	—	—	—	54 Participants	—
Summary of Metabolic Risk Factors Centrally distributed obesity	—	—	—	182 Participants	—

PRIMARY outcome

Timeframe: Baseline

Population: All subjects randomized to a treatment group were included in this baseline analysis.

Most frequently concomitant drug treatments used by \>15 participants.

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Summary of Most Frequently Used Concomitant Drug Treatments Akineton	12 Participants	24 Participants	0 Participants	6 Participants	11 Participants
Summary of Most Frequently Used Concomitant Drug Treatments Aloperidine	7 Participants	13 Participants	0 Participants	0 Participants	6 Participants
Summary of Most Frequently Used Concomitant Drug Treatments Biperiden	5 Participants	38 Participants	0 Participants	0 Participants	2 Participants
Summary of Most Frequently Used Concomitant Drug Treatments Clozapine	5 Participants	4 Participants	0 Participants	3 Participants	4 Participants
Summary of Most Frequently Used Concomitant Drug Treatments Haloperidol	7 Participants	45 Participants	1 Participants	1 Participants	4 Participants
Summary of Most Frequently Used Concomitant Drug Treatments Lorazepam	8 Participants	33 Participants	1 Participants	0 Participants	3 Participants
Summary of Most Frequently Used Concomitant Drug Treatments Olanzapine	6 Participants	20 Participants	0 Participants	0 Participants	1 Participants
Summary of Most Frequently Used Concomitant Drug Treatments Quetiapine	1 Participants	10 Participants	1 Participants	0 Participants	4 Participants
Summary of Most Frequently Used Concomitant Drug Treatments Risperidone	7 Participants	31 Participants	1 Participants	3 Participants	7 Participants
Summary of Most Frequently Used Concomitant Drug Treatments Tavor	4 Participants	9 Participants	1 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 12

Population: The Full Analysis Set (FAS) - all subjects who received at least 1 dose of study medication and have at least 1 efficacy measurement.

CGI-I: 7-point clinician rated scale ranging from 0 (not assessed) to 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) Much improved	39 Participants	105 Participants	2 Participants	7 Participants	18 Participants
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) Minimally improved	36 Participants	79 Participants	1 Participants	3 Participants	33 Participants
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) No change	3 Participants	23 Participants	1 Participants	3 Participants	3 Participants
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) Minimally worse	0 Participants	6 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) Not assessed	2 Participants	12 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) Very much improved	7 Participants	60 Participants	1 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS; Baseline Visit: 1 subject in the Ziprasidone \>=160mg group had missing severity result. Final Visit: 2 subjects (1 subject in the Ziprasidone 120mg to \<160mg and 1 subject in the Ziprasidone \<80mg group) had missing severity results.

CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 0 (not assessed) to 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. B = Baseline; F = Final Visit (Week 12)

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) F - Severely ill	1 Participants	13 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) B - Not assessed	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) F - Not assessed	2 Participants	12 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) F (only) - Normal, not at all ill	1 Participants	18 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) B - Borderline mentally ill	2 Participants	2 Participants	1 Participants	4 Participants	0 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) F - Borderline mentally ill	16 Participants	47 Participants	4 Participants	3 Participants	7 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) B - Mildly ill	6 Participants	17 Participants	2 Participants	4 Participants	11 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) F - Mildly ill	33 Participants	90 Participants	0 Participants	7 Participants	25 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) B - Moderately ill	45 Participants	80 Participants	0 Participants	6 Participants	26 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) F - Moderately ill	17 Participants	62 Participants	0 Participants	3 Participants	17 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) B - Markedly ill	24 Participants	108 Participants	1 Participants	1 Participants	16 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) F - Markedly ill	17 Participants	40 Participants	0 Participants	0 Participants	5 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) B - Severely ill	10 Participants	71 Participants	1 Participants	0 Participants	4 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) B - Among the most extremely ill	0 Participants	6 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S) F - Among the most extremely ill	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS

Modified positive subscale: clinician-rated measurement that consists of 30 items, each rated from 1 (absent) to 7 (extreme). Positive subscale (ranging from 4 to 28) taking the sum of the following 4 items: P1, delusions; P2, conceptual disorganization; P3, hallucinatory behavior; and P6, suspiciousness/persecution. Higher scores indicated greater severity of symptoms. The positive subscale total was calculated as the sum of the 4 items in the positive subscale.

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Baseline	14.6 Scores on a scale Standard Deviation 4.82	16.6 Scores on a scale Standard Deviation 5.28	12.6 Scores on a scale Standard Deviation 2.30	12.9 Scores on a scale Standard Deviation 4.12	14.4 Scores on a scale Standard Deviation 4.35
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Final	10.5 Scores on a scale Standard Deviation 4.41	10.4 Scores on a scale Standard Deviation 4.92	7.8 Scores on a scale Standard Deviation 3.03	10.2 Scores on a scale Standard Deviation 3.60	11.2 Scores on a scale Standard Deviation 4.35

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS

Modified negative subscale: assesses negative symptoms associated with schizophrenia. 7 items make up the Negative scale (eg, blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Negative Subscale scores range from 7 to 49. This negative subscale total was calculated as the sum of 4 items in the negative subscale.

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
PANSS - Negative Subscale Baseline	14.6 Scores on a scale Standard Deviation 5.30	14.7 Scores on a scale Standard Deviation 5.70	12.8 Scores on a scale Standard Deviation 5.81	16.7 Scores on a scale Standard Deviation 4.69	16.1 Scores on a scale Standard Deviation 4.05
PANSS - Negative Subscale Final	11.3 Scores on a scale Standard Deviation 4.78	10.6 Scores on a scale Standard Deviation 5.05	8.6 Scores on a scale Standard Deviation 5.18	14.1 Scores on a scale Standard Deviation 4.27	12.8 Scores on a scale Standard Deviation 4.67

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: FAS

The modified composite subscale total was calculated as the difference of the positive subscale total (7 items; total possible score of 49) and the negative subscale total (7 items; total possible score of 49). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The composite subscale total provided an indication of the level of dominance of the symptoms of one subscale over the symptoms of the other subscale. Higher scores indicated greater severity of symptoms.

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
PANSS - Composite Subscale Baseline	0.0 Scores on a scale Standard Deviation 5.14	1.9 Scores on a scale Standard Deviation 6.83	-0.2 Scores on a scale Standard Deviation 6.14	-3.8 Scores on a scale Standard Deviation 3.57	-1.7 Scores on a scale Standard Deviation 4.86
PANSS - Composite Subscale Final	-0.7 Scores on a scale Standard Deviation 3.60	-0.2 Scores on a scale Standard Deviation 4.57	-0.8 Scores on a scale Standard Deviation 2.95	-3.9 Scores on a scale Standard Deviation 2.82	-1.5 Scores on a scale Standard Deviation 3.92

SECONDARY outcome

Timeframe: Week 12

Population: FAS

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?" Extremely Dissatisfied	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?" Very Dissatisfied	1 Participants	5 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?" Dissatisfied	3 Participants	22 Participants	0 Participants	1 Participants	5 Participants
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?" Somewhat Satisfied	23 Participants	69 Participants	1 Participants	3 Participants	15 Participants
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?" Satisfied	40 Participants	102 Participants	1 Participants	6 Participants	25 Participants
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?" Very Satisfied	15 Participants	48 Participants	3 Participants	4 Participants	11 Participants
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Ability of the Medication to Prevent or Treat Your Condition?" Extremely Satisfied	3 Participants	27 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?" Extremely Dissatisfied	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?" Very Dissatisfied	2 Participants	6 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?" Dissatisfied	1 Participants	18 Participants	0 Participants	1 Participants	5 Participants
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?" Somewhat Satisfied	24 Participants	80 Participants	1 Participants	2 Participants	14 Participants
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?" Satisfied	38 Participants	86 Participants	0 Participants	7 Participants	22 Participants
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?" Very Satisfied	16 Participants	54 Participants	2 Participants	4 Participants	14 Participants
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Way the Medication Relieves Your Symptoms?" Extremely Satisfied	4 Participants	29 Participants	2 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 12

Population: FAS

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?" Extremely Dissatisfied	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?" Very Dissatisfied	1 Participants	4 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?" Dissatisfied	6 Participants	29 Participants	0 Participants	1 Participants	6 Participants
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?" Somewhat Satisfied	31 Participants	79 Participants	0 Participants	5 Participants	21 Participants
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?" Satisfied	32 Participants	96 Participants	2 Participants	6 Participants	21 Participants
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?" Very satisfied	12 Participants	41 Participants	3 Participants	2 Participants	7 Participants
Number of Participants Answering the Question "How Satisfied or Dissatisfied Are You With the Amount of Time it Takes the Medication to Start Working?" Extremely satisfied	3 Participants	23 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Number of Participants Answering the Question "As a Result of Taking This Medication, do You Experience Any Side Effects at All?" Yes	13 Participant	84 Participant	1 Participant	3 Participant	11 Participant
Number of Participants Answering the Question "As a Result of Taking This Medication, do You Experience Any Side Effects at All?" No	72 Participant	189 Participant	4 Participant	11 Participant	45 Participant

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Number of Participants Answering the Question "How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?" Extremely Bothersome	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?" Very Bothersome	1 Participants	9 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?" Somewhat Bothersome	3 Participants	29 Participants	0 Participants	0 Participants	8 Participants
Number of Participants Answering the Question "How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?" A Little Bothersome	7 Participants	41 Participants	1 Participants	3 Participants	3 Participants
Number of Participants Answering the Question "How Bothersome Are the Side Effects of the Medication You Take to Treat Your Condition?" Not At All Bothersome	2 Participants	4 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 12

Population: FAS

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?" A great deal	1 Participants	6 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?" Quite a bit	1 Participants	11 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?" Somewhat	3 Participants	31 Participants	0 Participants	1 Participants	4 Participants
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?" Minimally	7 Participants	28 Participants	1 Participants	2 Participants	3 Participants
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Physical Health and Ability to Function (ie, Ability to Think Clearly, Stay Awake, Etc)?" Not at all	1 Participants	8 Participants	0 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 12

Population: FAS

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?" A great deal	13 Participants	84 Participants	1 Participants	3 Participants	11 Participants
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?" Quite a bit	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?" Somewhat	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?" Minimally	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "To What Extent do the Side Effects Interfere With Your Mental Function (ie, Ability to Think, Stay Awake, Etc)?" Not at all	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 12

Population: FAS

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Number of Participants Answering the Question "To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?" A great deal	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?" Quite a bit	1 Participants	18 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?" Somewhat	2 Participants	26 Participants	0 Participants	1 Participants	5 Participants
Number of Participants Answering the Question "To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?" Minimally	4 Participants	27 Participants	1 Participants	1 Participants	2 Participants
Number of Participants Answering the Question "To What Degree Have Medication Side Effects Affected Your Overall Satisfaction With the Medication?" Not at all	5 Participants	10 Participants	0 Participants	1 Participants	4 Participants

SECONDARY outcome

Timeframe: Week 12

Population: FAS

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?" Extremely difficult	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?" Very difficult	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?" Difficult	3 Participants	13 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?" Somewhat easy	18 Participants	45 Participants	0 Participants	0 Participants	9 Participants
Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?" Easy	39 Participants	117 Participants	3 Participants	8 Participants	25 Participants
Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?" Very easy	16 Participants	71 Participants	2 Participants	4 Participants	15 Participants
Number of Participants Answering the Question "How Easy or Difficult is it to Use the Medication in Its Current Form?" Extremely easy	8 Participants	22 Participants	0 Participants	2 Participants	6 Participants

SECONDARY outcome

Timeframe: Week 12

Population: FAS

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Number of Participants Answering the Question "How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?" Extremely difficult	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?" Very difficult	1 Participants	4 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?" Difficult	7 Participants	25 Participants	0 Participants	1 Participants	1 Participants
Number of Participants Answering the Question "How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?" Somewhat easy	21 Participants	57 Participants	1 Participants	3 Participants	14 Participants
Number of Participants Answering the Question "How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?" Easy	37 Participants	108 Participants	1 Participants	7 Participants	25 Participants
Number of Participants Answering the Question "How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?" Very easy	15 Participants	54 Participants	3 Participants	1 Participants	7 Participants
Number of Participants Answering the Question "How Easy or Difficult is it to Plan When You Will Use the Medication Each Time?" Extremely easy	4 Participants	24 Participants	0 Participants	2 Participants	9 Participants

SECONDARY outcome

Timeframe: Week 12

Population: FAS

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?" Extremely inconvenient	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?" Very inconvenient	1 Participants	4 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?" Inconvenient	6 Participants	25 Participants	0 Participants	1 Participants	4 Participants
Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?" Somewhat convenient	30 Participants	71 Participants	1 Participants	2 Participants	12 Participants
Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?" Convenient	35 Participants	111 Participants	1 Participants	7 Participants	26 Participants
Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?" Very convenient	7 Participants	39 Participants	3 Participants	2 Participants	6 Participants
Number of Participants Answering the Question "How Convenient or Inconvenient is it to Take the Medication as Instructed?" Extremely convenient	6 Participants	21 Participants	0 Participants	2 Participants	8 Participants

SECONDARY outcome

Timeframe: Week 12

Population: FAS

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Number of Participants Answering the Question "Overall, How Confident Are You That Taking This Medication is a Good Thing?" Not at all confident	2 Participants	13 Participants	0 Participants	0 Participants	2 Participants
Number of Participants Answering the Question "Overall, How Confident Are You That Taking This Medication is a Good Thing?" A little confident	9 Participants	33 Participants	1 Participants	2 Participants	10 Participants
Number of Participants Answering the Question "Overall, How Confident Are You That Taking This Medication is a Good Thing?" Somewhat confident	33 Participants	88 Participants	3 Participants	6 Participants	21 Participants
Number of Participants Answering the Question "Overall, How Confident Are You That Taking This Medication is a Good Thing?" Very confident	34 Participants	100 Participants	0 Participants	6 Participants	22 Participants
Number of Participants Answering the Question "Overall, How Confident Are You That Taking This Medication is a Good Thing?" Extremely confident	7 Participants	36 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 12

Population: FAS

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Number of Participants Answering the Question "How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?" Not at all certain	2 Participants	15 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Answering the Question "How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?" A little certain	7 Participants	36 Participants	0 Participants	3 Participants	13 Participants
Number of Participants Answering the Question "How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?" Somewhat certain	26 Participants	81 Participants	2 Participants	6 Participants	21 Participants
Number of Participants Answering the Question "How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?" Very certain	44 Participants	101 Participants	3 Participants	5 Participants	20 Participants
Number of Participants Answering the Question "How Certain Are You That the Good Things About Your Medication Outweigh the Bad Things?" Extremely certain	6 Participants	39 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 12

Population: FAS

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?" Extremely dissatisfied	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?" Very dissatisfied	0 Participants	6 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?" Dissatisfied	3 Participants	17 Participants	0 Participants	1 Participants	5 Participants
Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?" Somewhat satisfied	16 Participants	64 Participants	1 Participants	1 Participants	19 Participants
Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?" Satisfied	37 Participants	89 Participants	1 Participants	7 Participants	17 Participants
Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?" Very satisfied	23 Participants	61 Participants	2 Participants	5 Participants	15 Participants
Number of Participants Answering the Question "Taking All Things Into Account, How Satisfied or Dissatisfied Are You With This Medication?" Extremely satisfied	5 Participants	32 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Safety population = all subjects who received at least 1 dose of study medication.

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Percent Change From Baseline to Final Visit in Body Weight	-1.0 percent change Standard Deviation 3.08	0.1 percent change Standard Deviation 4.70	-1.0 percent change Standard Deviation 2.05	1.2 percent change Standard Deviation 5.79	-0.2 percent change Standard Deviation 3.67

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 12

Population: FAS. Four subjects did not answer the question of continuation of treatment.

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=88 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=285 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown n=5 Participants Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=57 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period Yes	83 Participants	245 Participants	4 Participants	13 Participants	56 Participants
Number of Participants Continuing Treatment With Ziprasidone Following Completion of the Observation Period No	4 Participants	38 Participants	0 Participants	2 Participants	1 Participants

POST_HOC outcome

Timeframe: Week 12

Population: Within SmPC population: participants in FAS population who received all doses within SmPC. Within SmPC defined as all PO doses up to and including 160 mg per day and all IM doses up to and including 40 mg per day.

CGI-I: 7-point clinician rated scale ranging from 0 (not assessed) to 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=83 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=159 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=56 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I): Within Summary of Product Characteristics Population (SmPC) Not assessed	2 Participants	6 Participants	—	0 Participants	1 Participants
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I): Within Summary of Product Characteristics Population (SmPC) Very much improved	6 Participants	22 Participants	—	1 Participants	2 Participants
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I): Within Summary of Product Characteristics Population (SmPC) Much improved	39 Participants	62 Participants	—	7 Participants	17 Participants
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I): Within Summary of Product Characteristics Population (SmPC) Minimally improved	32 Participants	52 Participants	—	3 Participants	33 Participants
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I): Within Summary of Product Characteristics Population (SmPC) No change	3 Participants	14 Participants	—	3 Participants	3 Participants
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I): Within Summary of Product Characteristics Population (SmPC) Minimally worse	0 Participants	3 Participants	—	0 Participants	0 Participants

POST_HOC outcome

Timeframe: Baseline, Week 12

Population: Within SmPC

CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 0 (not assessed) to 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. B = Baseline; F = Final Visit (Week 12)

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=83 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=159 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=56 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC F - Severely ill	1 Participants	8 Participants	—	0 Participants	2 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC B - Not assessed	1 Participants	0 Participants	—	0 Participants	0 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC F - Not assessed	2 Participants	6 Participants	—	0 Participants	1 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC F (only) - Normal, not at all ill	1 Participants	6 Participants	—	1 Participants	0 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC B - Borderline mentally ill	2 Participants	1 Participants	—	4 Participants	0 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC F - Borderline mentally ill	14 Participants	24 Participants	—	3 Participants	7 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC B - Mildly ill	5 Participants	10 Participants	—	4 Participants	11 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC F - Mildly ill	31 Participants	53 Participants	—	7 Participants	24 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC B - Moderately ill	41 Participants	53 Participants	—	6 Participants	25 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC F - Moderately ill	16 Participants	38 Participants	—	3 Participants	17 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC B - Markedly ill	24 Participants	59 Participants	—	1 Participants	16 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC F - Markedly ill	17 Participants	22 Participants	—	0 Participants	5 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC B - Severely ill	10 Participants	33 Participants	—	0 Participants	4 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC B - Among the most extremely ill	0 Participants	2 Participants	—	0 Participants	0 Participants
Number of Participants With Categorical Scores on Clinical Global Impression of Severity (CGI-S): Within SmPC F - Among the most extremely ill	0 Participants	2 Participants	—	0 Participants	0 Participants

POST_HOC outcome

Timeframe: Baseline, Week 12

Population: Within SmPC; N=participants with evaluable data at observation

Modified positive subscale: clinician-rated measurement that consists of 30 items, each rated from 1 (absent) to 7 (extreme). Positive subscale (ranging from 4 to 28) taking the sum of the following 4 items: P1, delusions; P2, conceptual disorganization; P3, hallucinatory behavior; and P6, suspiciousness/persecution. Higher scores indicated greater severity of symptoms. The positive subscale total was calculated as the sum of the 4 items in the positive subscale.

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=82 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=158 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=56 Participants Ziprasidone between 80 mg and \< 120 mg per day.
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale: Within SmPC Baseline	14.8 Scores on a scale Standard Deviation 4.85	15.3 Scores on a scale Standard Deviation 5.27	—	12.9 Scores on a scale Standard Deviation 4.12	14.5 Scores on a scale Standard Deviation 4.37
Positive and Negative Syndrome Scale (PANSS) - Positive Subscale: Within SmPC Final	10.7 Scores on a scale Standard Deviation 4.47	10.0 Scores on a scale Standard Deviation 4.51	—	10.2 Scores on a scale Standard Deviation 3.60	11.3 Scores on a scale Standard Deviation 4.38

POST_HOC outcome

Timeframe: Baseline, Week 12

Population: Within SmPC; N=participants with evaluable data at observation

Modified negative subscale: assesses negative symptoms associated with schizophrenia. 7 items make up the Negative scale (eg, blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Negative Subscale scores range from 7 to 49. This negative subscale total was calculated as the sum of 4 items in the negative subscale.

Outcome measures

Outcome measures
Measure	Ziprasidone 120 mg to < 160 mg n=82 Participants Ziprasidone between 120 mg and \< 160 mg per day.	Ziprasidone >= 160 mg n=157 Participants Ziprasidone 160 mg or greater per day.	Ziprasidone Unknown Details are unknown.	Ziprasidone < 80 mg n=15 Participants Ziprasidone up to 80 milligrams (mg) per day.	Ziprasidone 80 mg to < 120 mg n=55 Participants Ziprasidone between 80 mg and \< 120 mg per day.
PANSS - Negative Subscale: Within SmPC Baseline	14.8 Scores on a scale Standard Deviation 5.22	14.5 Scores on a scale Standard Deviation 5.91	—	16.7 Scores on a scale Standard Deviation 4.69	16.0 Scores on a scale Standard Deviation 4.06
PANSS - Negative Subscale: Within SmPC Final	11.4 Scores on a scale Standard Deviation 4.76	11.1 Scores on a scale Standard Deviation 5.33	—	14.1 Scores on a scale Standard Deviation 4.27	12.7 Scores on a scale Standard Deviation 4.71

POST_HOC outcome

Timeframe: Baseline, Week 12

Population: Within SmPC; N=participants with evaluable data at observation

The modified composite subscale total was calculated as the difference of the positive subscale total (7 items; total possible score of 49) and the negative subscale total (7 items; total possible score of 49). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The composite subscale total provided an indication of the level of dominance of the symptoms of one subscale over the symptoms of the other subscale. Higher scores indicated greater severity of symptoms.