Trial Outcomes & Findings for Non Interventional Study In Bipolar Disorder And Schizophrenia With Zeldox (NCT NCT00538629)
NCT ID: NCT00538629
Last Updated: 2022-11-18
Results Overview
CGI-S assesses the severity of the condition at baseline using a scale that ranges from (1)Normal, not ill at all to (7) Among the most severely ill patients.
Recruitment status
COMPLETED
Target enrollment
471 participants
Primary outcome timeframe
Baseline
Results posted on
2022-11-18
Participant Flow
Subjects enrolled had to have taken at least 1 dose of 40, 60, or 80 milligrams of ziprasidone. The study included subjects with diagnosed Type I or II bipolar disorder with manic and mixed episodes (n=223) and subjects with schizophrenia of up to moderate severity, either first diagnosed or repeated episodes (n=248).
Participant milestones
| Measure |
Ziprasidone
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Overall Study
STARTED
|
471
|
|
Overall Study
COMPLETED
|
449
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
Ziprasidone
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Overall Study
At subject's request
|
1
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lack of Efficacy
|
12
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Subject's untimely distrust of medicine
|
1
|
Baseline Characteristics
Non Interventional Study In Bipolar Disorder And Schizophrenia With Zeldox
Baseline characteristics by cohort
| Measure |
Ziprasidone
n=471 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Age, Customized
<18 years
|
2 Participants
n=99 Participants
|
|
Age, Customized
18-44 years
|
294 Participants
n=99 Participants
|
|
Age, Customized
45-64 years
|
152 Participants
n=99 Participants
|
|
Age, Customized
>=65 years
|
23 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Male
|
198 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Female
|
271 Participants
n=99 Participants
|
|
Sex/Gender, Customized
Unspecified
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.
CGI-S assesses the severity of the condition at baseline using a scale that ranges from (1)Normal, not ill at all to (7) Among the most severely ill patients.
Outcome measures
| Measure |
Ziprasidone
n=222 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population)
(1) Normal, not ill
|
3 Participants
|
|
Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population)
(2) Borderline mentally ill
|
5 Participants
|
|
Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population)
(3) Mildly ill
|
19 Participants
|
|
Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population)
(4) Moderately ill
|
57 Participants
|
|
Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population)
(5) Absolutely clearly ill
|
101 Participants
|
|
Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population)
(6) Severely ill
|
24 Participants
|
|
Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population)
(7) Among the most extremely ill subjects
|
0 Participants
|
|
Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population)
Missing
|
13 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=176 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?
Baseline: Could not be worse
|
13 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?
Baseline: Displeased
|
45 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?
Baseline: Mostly dissatisfied
|
36 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?
Baseline: Mixed
|
44 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?
Baseline: Mostly satisfied
|
19 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?
Baseline: Pleased
|
17 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?
Baseline: Could not be better
|
2 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?
Baseline: Missing
|
68 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?
Final: Could not be worse
|
2 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?
Final: Displeased
|
20 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?
Final: Mostly dissatisfied
|
23 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?
Final: Mixed
|
54 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?
Final: Mostly satisfied
|
48 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?
Final: Pleased
|
26 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?
Final: Could not be better
|
1 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?
Final: Missing
|
70 Participants
|
PRIMARY outcome
Timeframe: Baseline to final visit (12 weeks)Population: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. If the final visit measurement was missing, the follow-up measurement could be carried forward. If any individual item was missing, the total score was set to missing. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
The YMRS is an 11-item questionnaire that rates the severity of bipolar disorder, with higher score indicating greater severity of disease. Change: score at final visit minus score at baseline.
Outcome measures
| Measure |
Ziprasidone
n=208 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Young Mania Rating Scale (YMRS) Scores (Bipolar Population): Change From Baseline
Baseline
|
26.6 Score on scale
Standard Deviation 12.6
|
|
Young Mania Rating Scale (YMRS) Scores (Bipolar Population): Change From Baseline
Final visit
|
10.8 Score on scale
Standard Deviation 8.3
|
|
Young Mania Rating Scale (YMRS) Scores (Bipolar Population): Change From Baseline
Change from baseline
|
-15.6 Score on scale
Standard Deviation 9.4
|
PRIMARY outcome
Timeframe: Baseline to final visit (12 weeks)Population: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication. If any individual item was missing, the total score was set to missing. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
MADRS measures treatment effect on depression severity. MADRS assesses apparent and reported sadness, inner tension, sleep, appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Higher score indicates greater severity of disease. Change: score at final visit minus score at baseline.
Outcome measures
| Measure |
Ziprasidone
n=214 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Montgomery Asberg Depression Rating Scale (MADRS) Scores (Bipolar Population): Change From Baseline
Baseline
|
26.2 Score on scale
Standard Deviation 20.3
|
|
Montgomery Asberg Depression Rating Scale (MADRS) Scores (Bipolar Population): Change From Baseline
Final visit
|
11.6 Score on scale
Standard Deviation 9.1
|
|
Montgomery Asberg Depression Rating Scale (MADRS) Scores (Bipolar Population): Change From Baseline
Change from baseline
|
-14.6 Score on scale
Standard Deviation 16.1
|
PRIMARY outcome
Timeframe: Final visit (week 12)Population: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.
CGI-C assesses change in severity of the conditionusing a scale that ranges from (1) very much improved to (7) very much worse. Higher score indicates increasing severity of disease.
Outcome measures
| Measure |
Ziprasidone
n=222 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Clinical Global Impressions Change (CGI-C) Scores (Bipolar Population)
(1) Very much improved
|
40 Participants
|
|
Clinical Global Impressions Change (CGI-C) Scores (Bipolar Population)
(2) Much improved
|
117 Participants
|
|
Clinical Global Impressions Change (CGI-C) Scores (Bipolar Population)
(3) Minimally improved
|
52 Participants
|
|
Clinical Global Impressions Change (CGI-C) Scores (Bipolar Population)
(4) No change
|
5 Participants
|
|
Clinical Global Impressions Change (CGI-C) Scores (Bipolar Population)
(5) Minimally worse
|
1 Participants
|
|
Clinical Global Impressions Change (CGI-C) Scores (Bipolar Population)
(6) Much worse
|
3 Participants
|
|
Clinical Global Impressions Change (CGI-C) Scores (Bipolar Population)
(7) Very much worse
|
0 Participants
|
|
Clinical Global Impressions Change (CGI-C) Scores (Bipolar Population)
Missing
|
4 Participants
|
PRIMARY outcome
Timeframe: Final visit (week 12)Population: The schizophrenia full analysis set included all subjects who had been diagnosed with schizophrenia and had received at least 1 dose of study medication.
CGI-C assesses change in severity of the conditionusing a scale that ranges from (1) very much improved to (7) very much worse. Higher score indicates increasing severity of disease.
Outcome measures
| Measure |
Ziprasidone
n=244 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Clinical Global Impressions Change (CGI-C) Scores (Schizoprenia Population)
(1) Very much improved
|
22 Participants
|
|
Clinical Global Impressions Change (CGI-C) Scores (Schizoprenia Population)
(2) Much improved
|
125 Participants
|
|
Clinical Global Impressions Change (CGI-C) Scores (Schizoprenia Population)
(3) Minimally improved
|
76 Participants
|
|
Clinical Global Impressions Change (CGI-C) Scores (Schizoprenia Population)
(4) No change
|
14 Participants
|
|
Clinical Global Impressions Change (CGI-C) Scores (Schizoprenia Population)
(5) Minimally worse
|
1 Participants
|
|
Clinical Global Impressions Change (CGI-C) Scores (Schizoprenia Population)
(6) Much worse
|
3 Participants
|
|
Clinical Global Impressions Change (CGI-C) Scores (Schizoprenia Population)
(7) Very much worse
|
0 Participants
|
|
Clinical Global Impressions Change (CGI-C) Scores (Schizoprenia Population)
Missing
|
3 Participants
|
PRIMARY outcome
Timeframe: Baseline to final visit (week 12)Population: The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. If any individual item was missing, the total score was set to missing. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.
BPRS is an 18-item scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items. The physician completes the BPRS, and each item is scored on a 7-point scale, with higher score indicating greater severity of symptom. Change: score at final visit minus score at baseline.
Outcome measures
| Measure |
Ziprasidone
n=205 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Brief Psychiatric Rating Scale (BPRS) Scores (Schizophrenia Population): Change From Baseline
Baseline
|
49.3 Score on scale
Standard Deviation 17.9
|
|
Brief Psychiatric Rating Scale (BPRS) Scores (Schizophrenia Population): Change From Baseline
Final visit
|
35.2 Score on scale
Standard Deviation 11.3
|
|
Brief Psychiatric Rating Scale (BPRS) Scores (Schizophrenia Population): Change From Baseline
Change from baseline
|
-20.0 Score on scale
Standard Deviation 13.4
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication. If any individual item was missing, the total score was set to missing.
EPS assesses 4 items: akathisia, dystonia, dyskinesia, and parkinsonism. Each item is scored on a 5-point severity scale ranging from 1 to 5, with higher score indicating greater severity of symptom. Change: score at final visit minus score at baseline.
Outcome measures
| Measure |
Ziprasidone
n=244 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Extrapyramidal Symptom (EPS) Scores (Schizophrenia Population: Baseline and Final Visit
Baseline
|
7.0 Score on scale
Standard Deviation 4.7
|
|
Extrapyramidal Symptom (EPS) Scores (Schizophrenia Population: Baseline and Final Visit
Final visit
|
4.4 Score on scale
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: Final visit (week 12)Population: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.
The Global Efficacy Evaluation assesses the final efficacy of ziprasidone on bipolar symptoms using a 5-point scale that ranges from very good to worsening of the original disease.
Outcome measures
| Measure |
Ziprasidone
n=222 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Global Efficacy Evaluation Scores (Bipolar Population)
Very good
|
154 Participants
|
|
Global Efficacy Evaluation Scores (Bipolar Population)
Good
|
24 Participants
|
|
Global Efficacy Evaluation Scores (Bipolar Population)
Average
|
36 Participants
|
|
Global Efficacy Evaluation Scores (Bipolar Population)
Poor
|
4 Participants
|
|
Global Efficacy Evaluation Scores (Bipolar Population)
Worsening of the original disease
|
1 Participants
|
|
Global Efficacy Evaluation Scores (Bipolar Population)
Missing
|
3 Participants
|
PRIMARY outcome
Timeframe: Final visit (week 12)Population: The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.
The Global Efficacy Evaluation assesses the final efficacy of ziprasidone on schizophrenia symptoms using a 5-point scale that ranges from very good to worsening of the original disease.
Outcome measures
| Measure |
Ziprasidone
n=244 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Global Efficacy Evaluation Scores (Schizophrenia Population)
Very good
|
166 Participants
|
|
Global Efficacy Evaluation Scores (Schizophrenia Population)
Good
|
28 Participants
|
|
Global Efficacy Evaluation Scores (Schizophrenia Population)
Average
|
35 Participants
|
|
Global Efficacy Evaluation Scores (Schizophrenia Population)
Poor
|
7 Participants
|
|
Global Efficacy Evaluation Scores (Schizophrenia Population)
Worsening of the original disease
|
3 Participants
|
|
Global Efficacy Evaluation Scores (Schizophrenia Population)
Missing
|
5 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=222 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Baseline: Could not be worse
|
8 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Baseline: Displeased
|
27 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Baseline: Mostly dissatisfied
|
26 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Baseline: Mixed
|
25 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Baseline: Mostly satisfied
|
29 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Baseline: Pleased
|
29 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Baseline: Could not be better
|
11 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Baseline: Missing
|
67 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Final: Could not be worse
|
2 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Final: Displeased
|
10 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Final: Mostly dissatisfied
|
18 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Final: Mixed
|
28 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Final: Mostly satisfied
|
56 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Final: Pleased
|
36 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Final: Could not be better
|
3 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Final: Missing
|
69 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=222 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?
Final: Could not be worse
|
0 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?
Final: Displeased
|
13 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?
Final: Mostly dissatisfied
|
21 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?
Final: Mixed
|
32 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?
Final: Mostly satisfied
|
47 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?
Final: Pleased
|
38 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?
Final: Could not be better
|
1 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?
Final: Missing
|
70 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?
Baseline: Could not be worse
|
5 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?
Baseline: Displeased
|
28 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?
Baseline: Mostly dissatisfied
|
28 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?
Baseline: Mixed
|
22 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?
Baseline: Mostly satisfied
|
33 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?
Baseline: Pleased
|
33 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?
Baseline: Could not be better
|
6 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?
Baseline: Missing
|
67 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The bipolar full analysis set included all subjects who had been diagnosed with bipolar mania and had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=222 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Baseline: Could not be worse
|
9 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Baseline: Displeased
|
48 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Baseline: Mostly dissatisfied
|
37 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Baseline: Mixed
|
17 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Baseline: Mostly satisfied
|
21 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Baseline: Pleased
|
14 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Baseline: Could not be better
|
5 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Baseline: Missing
|
71 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Final: Could not be worse
|
1 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Final: Displeased
|
33 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Final: Mostly dissatisfied
|
41 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Final: Mixed
|
24 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Final: Mostly satisfied
|
24 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Final: Pleased
|
24 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Final: Could not be better
|
1 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Final: Missing
|
74 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The bipolar full analysis set included all subjects who had been diagnosed with bipolar mania and had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=222 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?
Baseline: Yes
|
112 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?
Baseline: No
|
41 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?
Baseline: Missing
|
69 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?
Final: Yes
|
113 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?
Final: No
|
37 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?
Final: Missing
|
72 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The bipolar full analysis set included all subjects who had been diagnosed with bipolar mania and had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=222 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Last Week Have You Seen a Friend?
Baseline: Yes
|
88 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Last Week Have You Seen a Friend?
Baseline: No
|
66 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Last Week Have You Seen a Friend?
Baseline: Missing
|
68 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Last Week Have You Seen a Friend?
Final: Yes
|
95 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Last Week Have You Seen a Friend?
Final: No
|
54 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Last Week Have You Seen a Friend?
Final: Missing
|
73 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=222 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Baseline: Could not be worse
|
2 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Baseline: Displeased
|
32 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Baseline: Mostly dissatisfied
|
22 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Baseline: Mixed
|
27 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Baseline: Mostly satisfied
|
34 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Baseline: Pleased
|
29 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Baseline: Could not be better
|
9 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Baseline: Missing
|
67 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Final: Could not be worse
|
1 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Final: Displeased
|
18 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Final: Mostly dissatisfied
|
24 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Final: Mixed
|
26 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Final: Mostly satisfied
|
43 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Final: Pleased
|
40 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Final: Could not be better
|
0 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Final: Missing
|
70 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=222 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?
Baseline: Could not be worse
|
3 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?
Baseline: Displeased
|
19 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?
Baseline: Mostly dissatisfied
|
17 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?
Baseline: Mixed
|
17 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?
Baseline: Mostly satisfied
|
39 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?
Baseline: Pleased
|
50 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?
Baseline: Could not be better
|
7 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?
Baseline: Missing
|
70 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?
Final: Could not be worse
|
0 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?
Final: Displeased
|
16 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?
Final: Mostly dissatisfied
|
11 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?
Final: Mixed
|
18 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?
Final: Mostly satisfied
|
48 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?
Final: Pleased
|
53 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?
Final: Could not be better
|
0 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?
Final: Missing
|
76 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=222 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Baseline: Could not be worse
|
4 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Baseline: Displeased
|
28 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Baseline: Mostly dissatisfied
|
29 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Baseline: Mixed
|
19 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Baseline: Mostly satisfied
|
31 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Baseline: Pleased
|
31 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Baseline: Could not be better
|
13 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Baseline: Missing
|
67 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Final: Could not be worse
|
0 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Final: Displeased
|
13 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Final: Mostly dissatisfied
|
24 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Final: Mixed
|
26 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Final: Mostly satisfied
|
49 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Final: Pleased
|
40 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Final: Could not be better
|
0 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Final: Missing
|
70 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=222 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year Have You Been Accused of a Crime?
Baseline: Yes
|
7 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year Have You Been Accused of a Crime?
Baseline: No
|
146 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year Have You Been Accused of a Crime?
Baseline: Missing
|
69 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year Have You Been Accused of a Crime?
Final: Yes
|
6 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year Have You Been Accused of a Crime?
Final: No
|
143 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year Have You Been Accused of a Crime?
Final: Missing
|
73 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=222 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?
Baseline: Yes
|
10 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?
Baseline: No
|
144 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?
Baseline: Missing
|
68 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?
Final: Yes
|
9 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?
Final: No
|
141 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?
Final: Missing
|
72 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=222 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Baseline: Could not be worse
|
1 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Baseline: Displeased
|
14 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Baseline: Mostly dissatisfied
|
12 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Baseline: Mixed
|
35 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Baseline: Mostly satisfied
|
37 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Baseline: Pleased
|
50 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Baseline: Could not be better
|
6 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Baseline: Missing
|
67 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Final: Could not be worse
|
2 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Final: Displeased
|
6 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Final: Mostly dissatisfied
|
6 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Final: Mixed
|
21 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Final: Mostly satisfied
|
54 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Final: Pleased
|
58 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Final: Could not be better
|
6 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Final: Missing
|
69 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=222 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?
Baseline: Could not be worse
|
0 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?
Baseline: Displeased
|
17 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?
Baseline: Mostly dissatisfied
|
17 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?
Baseline: Mixed
|
28 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?
Baseline: Mostly satisfied
|
38 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?
Baseline: Pleased
|
47 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?
Baseline: Could not be better
|
7 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?
Baseline: Missing
|
68 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?
Final: Could not be worse
|
0 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?
Final: Displeased
|
8 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?
Final: Mostly dissatisfied
|
15 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?
Final: Mixed
|
19 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?
Final: Mostly satisfied
|
48 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?
Final: Pleased
|
59 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?
Final: Could not be better
|
3 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?
Final: Missing
|
70 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=222 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?
Baseline: Could not be worse
|
11 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?
Baseline: Displeased
|
41 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?
Baseline: Mostly dissatisfied
|
17 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?
Baseline: Mixed
|
32 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?
Baseline: Mostly satisfied
|
15 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?
Baseline: Pleased
|
29 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?
Baseline: Could not be better
|
10 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?
Baseline: Missing
|
67 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?
Final: Could not be worse
|
6 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?
Final: Displeased
|
28 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?
Final: Mostly dissatisfied
|
22 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?
Final: Mixed
|
27 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?
Final: Mostly satisfied
|
34 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?
Final: Pleased
|
36 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?
Final: Could not be better
|
0 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?
Final: Missing
|
69 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=222 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Baseline: Could not be worse
|
2 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Baseline: Displeased
|
17 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Baseline: Mostly dissatisfied
|
17 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Baseline: Mixed
|
43 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Baseline: Mostly satisfied
|
31 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Baseline: Pleased
|
38 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Baseline: Could not be better
|
7 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Baseline: Missing
|
67 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Final: Could not be worse
|
0 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Final: Displeased
|
6 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Final: Mostly dissatisfied
|
12 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Final: Mixed
|
29 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Final: Mostly satisfied
|
50 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Final: Pleased
|
55 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Final: Could not be better
|
1 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Final: Missing
|
69 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=222 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?
Baseline: Could not be worse
|
7 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?
Baseline: Displeased
|
13 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?
Baseline: Mostly dissatisfied
|
15 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?
Baseline: Mixed
|
22 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?
Baseline: Mostly satisfied
|
39 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?
Baseline: Pleased
|
50 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?
Baseline: Could not be better
|
9 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?
Baseline: Missing
|
67 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?
Final: Could not be worse
|
1 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?
Final: Displeased
|
11 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?
Final: Mostly dissatisfied
|
9 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?
Final: Mixed
|
22 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?
Final: Mostly satisfied
|
49 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?
Final: Pleased
|
60 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?
Final: Could not be better
|
1 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?
Final: Missing
|
69 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=222 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?
Baseline: Could not be worse
|
6 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?
Baseline: Displeased
|
29 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?
Baseline: Mostly dissatisfied
|
19 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?
Baseline: Mixed
|
32 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?
Baseline: Mostly satisfied
|
18 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?
Baseline: Pleased
|
35 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?
Baseline: Could not be better
|
15 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?
Baseline: Missing
|
68 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?
Final: Could not be worse
|
0 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?
Final: Displeased
|
9 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?
Final: Mostly dissatisfied
|
17 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?
Final: Mixed
|
34 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?
Final: Mostly satisfied
|
45 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?
Final: Pleased
|
45 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?
Final: Could not be better
|
3 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?
Final: Missing
|
69 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=244 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Baseline: Could not be worse
|
13 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Baseline: Displeased
|
48 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Baseline: Mostly dissatisfied
|
37 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Baseline: Mixed
|
43 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Baseline: Mostly satisfied
|
30 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Baseline: Pleased
|
6 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Baseline: Could not be better
|
0 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Baseline: Missing
|
67 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Final: Could not be worse
|
0 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Final: Displeased
|
21 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Final: Mostly dissatisfied
|
23 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Final: Mixed
|
48 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Final: Mostly satisfied
|
69 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Final: Pleased
|
14 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Final: Could not be better
|
0 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Life as a Whole Today?
Final: Missing
|
69 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=244 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?
Baseline: Could not be worse
|
5 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?
Baseline: Displeased
|
36 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?
Baseline: Mostly dissatisfied
|
40 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?
Baseline: Mixed
|
39 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?
Baseline: Mostly satisfied
|
33 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?
Baseline: Pleased
|
22 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?
Baseline: Could not be better
|
0 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?
Baseline: Missing
|
69 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?
Final: Could not be worse
|
1 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?
Final: Displeased
|
23 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?
Final: Mostly dissatisfied
|
36 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?
Final: Mixed
|
33 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?
Final: Mostly satisfied
|
53 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?
Final: Pleased
|
27 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?
Final: Could not be better
|
0 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?
Final: Missing
|
71 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=244 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Baseline: Could not be worse
|
8 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Baseline: Displeased
|
70 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Baseline: Mostly dissatisfied
|
39 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Baseline: Mixed
|
23 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Baseline: Mostly satisfied
|
18 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Baseline: Pleased
|
13 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Baseline: Could not be better
|
1 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Baseline: Missing
|
72 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Final: Could not be worse
|
1 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Final: Displeased
|
40 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Final: Mostly dissatisfied
|
54 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Final: Mixed
|
35 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Final: Mostly satisfied
|
20 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Final: Pleased
|
18 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Final: Could not be better
|
0 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Final: Missing
|
76 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=244 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?
Baseline: Yes
|
113 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?
Baseline: No
|
64 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?
Baseline: Missing
|
67 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?
Final: Yes
|
114 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?
Final: No
|
58 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?
Final: Missing
|
72 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=244 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Last Week Have You Seen a Friend?
Baseline: Yes
|
87 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Last Week Have You Seen a Friend?
Baseline: No
|
86 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Last Week Have You Seen a Friend?
Baseline: Missing
|
71 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Last Week Have You Seen a Friend?
Final: Yes
|
98 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Last Week Have You Seen a Friend?
Final: No
|
72 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Last Week Have You Seen a Friend?
Final: Missing
|
74 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=244 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Baseline: Could not be worse
|
3 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Baseline: Displeased
|
45 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Baseline: Mostly dissatisfied
|
37 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Baseline: Mixed
|
31 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Baseline: Mostly satisfied
|
36 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Baseline: Pleased
|
23 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Baseline: Could not be better
|
2 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Baseline: Missing
|
67 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Final: Could not be worse
|
3 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Final: Displeased
|
23 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Final: Mostly dissatisfied
|
35 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Final: Mixed
|
36 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Final: Mostly satisfied
|
50 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Final: Pleased
|
26 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Final: Could not be better
|
1 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the Number and Quality of Your Friendships?
Final: Missing
|
70 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=244 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Baseline: Could not be worse
|
2 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Baseline: Displeased
|
52 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Baseline: Mostly dissatisfied
|
46 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Baseline: Mixed
|
31 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Baseline: Mostly satisfied
|
29 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Baseline: Pleased
|
15 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Baseline: Could not be better
|
2 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Baseline: Missing
|
67 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Final: Could not be worse
|
1 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Final: Displeased
|
15 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Final: Mostly dissatisfied
|
38 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Final: Mixed
|
34 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Final: Mostly satisfied
|
72 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Final: Pleased
|
14 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Final: Could not be better
|
0 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Final: Missing
|
70 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=244 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?
Baseline: Could not be worse
|
4 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?
Baseline: Displeased
|
31 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?
Baseline: Mostly dissatisfied
|
24 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?
Baseline: Mixed
|
26 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?
Baseline: Mostly satisfied
|
41 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?
Baseline: Pleased
|
46 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?
Baseline: Could not be better
|
3 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?
Baseline: Missing
|
69 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?
Final: Could not be worse
|
1 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?
Final: Displeased
|
15 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?
Final: Mostly dissatisfied
|
17 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?
Final: Mixed
|
38 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?
Final: Mostly satisfied
|
45 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?
Final: Pleased
|
51 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?
Final: Could not be better
|
2 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?
Final: Missing
|
75 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visitPopulation: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=244 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been Accused of a Crime?
Baseline: Yes
|
4 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been Accused of a Crime?
Baseline: No
|
173 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been Accused of a Crime?
Baseline: Missing
|
67 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been Accused of a Crime?
Final: Yes
|
5 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been Accused of a Crime?
Final: No
|
170 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been Accused of a Crime?
Final: Missing
|
69 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=244 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?
Baseline: Yes
|
11 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?
Baseline: No
|
165 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?
Baseline: Missing
|
68 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?
Final: Yes
|
9 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?
Final: No
|
166 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Past Year, Have You Been a Victim of Physical Violence?
Final: Missing
|
69 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=244 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Baseline: Could not be worse
|
6 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Baseline: Displeased
|
34 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Baseline: Mostly dissatisfied
|
27 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Baseline: Mixed
|
45 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Baseline: Mostly satisfied
|
30 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Baseline: Pleased
|
27 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Baseline: Could not be better
|
8 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Baseline: Missing
|
67 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Final: Could not be worse
|
2 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Final: Displeased
|
11 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Final: Mostly dissatisfied
|
14 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Final: Mixed
|
33 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Final: Mostly satisfied
|
63 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Final: Pleased
|
45 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Final: Could not be better
|
7 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Final: Missing
|
69 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher number indicating higher satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=244 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?
Baseline: Could not be worse
|
9 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?
Baseline: Displeased
|
26 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?
Baseline: Mostly dissatisfied
|
27 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?
Baseline: Mixed
|
35 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?
Baseline: Mostly satisfied
|
43 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?
Baseline: Pleased
|
32 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?
Baseline: Could not be better
|
4 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?
Baseline: Missing
|
68 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?
Final: Could not be worse
|
4 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?
Final: Displeased
|
11 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?
Final: Mostly dissatisfied
|
18 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?
Final: Mixed
|
34 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?
Final: Mostly satisfied
|
61 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?
Final: Pleased
|
42 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?
Final: Could not be better
|
4 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?
Final: Missing
|
70 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia and who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=244 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?
Baseline: Could not be worse
|
19 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?
Baseline: Displeased
|
59 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?
Baseline: Mostly dissatisfied
|
38 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?
Baseline: Mixed
|
26 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?
Baseline: Mostly satisfied
|
20 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?
Baseline: Pleased
|
13 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?
Baseline: Could not be better
|
1 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?
Baseline: Missing
|
68 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?
Final: Could not be worse
|
9 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?
Final: Displeased
|
47 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?
Final: Mostly dissatisfied
|
44 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?
Final: Mixed
|
38 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?
Final: Mostly satisfied
|
20 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?
Final: Pleased
|
16 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?
Final: Could not be better
|
0 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?
Final: Missing
|
70 Participants
|
PRIMARY outcome
Timeframe: Baseline and final visit (week 12)Population: The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=244 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Baseline: Could not be worse
|
3 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Baseline: Displeased
|
29 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Baseline: Mostly dissatisfied
|
32 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Baseline: Mixed
|
38 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Baseline: Mostly satisfied
|
41 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Baseline: Pleased
|
30 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Baseline: Could not be better
|
3 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Baseline: Missing
|
68 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Final: Could not be worse
|
1 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Final: Displeased
|
11 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Final: Mostly dissatisfied
|
20 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Final: Mixed
|
40 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Final: Mostly satisfied
|
58 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Final: Pleased
|
43 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Final: Could not be better
|
2 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Final: Missing
|
69 Participants
|
PRIMARY outcome
Timeframe: Baseline to final visit (week 12)Population: The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication.
MANSA is a 16-item self-assessment of satisfaction with quality of life. Items are rated on a 7-point scale, with higher score indicating greater satisfaction.
Outcome measures
| Measure |
Ziprasidone
n=244 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?
Baseline: Could not be worse
|
4 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?
Baseline: Displeased
|
31 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?
Baseline: Mostly dissatisfied
|
27 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?
Baseline: Mixed
|
36 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?
Baseline: Mostly satisfied
|
40 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?
Baseline: Pleased
|
37 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?
Baseline: Could not be better
|
1 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?
Baseline: Missing
|
68 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?
Final: Could not be worse
|
0 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?
Final: Displeased
|
18 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?
Final: Mostly dissatisfied
|
14 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?
Final: Mixed
|
26 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?
Final: Mostly satisfied
|
66 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?
Final: Pleased
|
50 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?
Final: Could not be better
|
1 Participants
|
|
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?
Final: Missing
|
69 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: The schizophrenia full analysis set included all subjects with a diagnosis of schizophrenia who had received at least 1 dose of study medication
CGI-S assesses the severity of the condition at baseline using a scale that ranges from (1)Normal, not ill at all to (7) Among the most severely ill patients.
Outcome measures
| Measure |
Ziprasidone
n=244 Participants
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
Clinical Global Impression of Severity (CGI-S) Scores (Schizophrenia Population)
(1) Normal, not ill
|
1 Participants
|
|
Clinical Global Impression of Severity (CGI-S) Scores (Schizophrenia Population)
(2) Borderline mentally ill
|
5 Participants
|
|
Clinical Global Impression of Severity (CGI-S) Scores (Schizophrenia Population)
(3) Mildly ill
|
14 Participants
|
|
Clinical Global Impression of Severity (CGI-S) Scores (Schizophrenia Population)
(4) Moderately ill
|
63 Participants
|
|
Clinical Global Impression of Severity (CGI-S) Scores (Schizophrenia Population)
(5) Absolutely clearly ill
|
105 Participants
|
|
Clinical Global Impression of Severity (CGI-S) Scores (Schizophrenia Population)
(6) Severely ill
|
33 Participants
|
|
Clinical Global Impression of Severity (CGI-S) Scores (Schizophrenia Population)
(7) Among the most severely ill subjects
|
0 Participants
|
|
Clinical Global Impression of Severity (CGI-S) Scores (Schizophrenia Population)
Missing
|
23 Participants
|
Adverse Events
Ziprasidone
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ziprasidone
n=471 participants at risk
Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
|
|---|---|
|
General disorders
Asthenia
|
0.21%
1/471
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Condition aggrevated
|
0.21%
1/471
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
0.64%
3/471
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Ill-defined disorder
|
0.21%
1/471
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Rhinitis
|
0.21%
1/471
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Akathisia
|
0.21%
1/471
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dyskinesia
|
0.42%
2/471
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.85%
4/471
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
0.21%
1/471
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Parkinsonism
|
0.21%
1/471
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Sedation
|
0.21%
1/471
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
0.21%
1/471
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER