Bipolar DisorderNCT00538629

Non Interventional Study In Bipolar Disorder And Schizophrenia With Zeldox

An observational study of Bipolar Disorder and Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Investigation of the impact of Zeldox on metabolic parametres in patients with bipolar disorder or with schizophrenia and impact of the treatment for the quality of life Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bipolar Disorder, Schizophrenia
How many people: 471 participants
Where: No sites listed yet
Study dates: 16 Oct 2007to 30 Apr 2008
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: psychiatric outpatients

Who may be able to join

Manic and mixed episodes of up to moderate severity in patients with type I and II bipolar disorder and schizophrenia; either first diagnosed or repeated episodes.

Who cannot join

Patients with a history of hypersenzitivity to Ziprasidone. Previous insufficiency of the Ziprasidone´s treatment. The break of the previous therapeutic condition.

About this study

Official title: NON INTERVENTIONAL STUDY (NIS) IN PATIENTS WITH BIPOLAR DISCORDER (MANIC OR MIXED EPISODES) AND SCHIZOPHRENIA UNDERGOING TREATEMENT WITH ZELDOX

Investigation of the impact of Zeldox on metabolic parametres in patients with bipolar disorder or with schizophrenia and impact of the treatment for the quality of life

Read the detailed description

observational survey consecutive patient sampling

Conditions: Bipolar Disorder, Schizophrenia
Being tested: no intervention
Medical subject headings: Bipolar Disorder, Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

no interventionOther
no intervention
no interventionOther
no intervention

Study groups in NCT00538629
Study group	Role	What they receive
schizophrenic		patients with schizophrenia Receives: Other: no intervention
bipolar disorder		patients with bipolar disorder Receives: Other: no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population)
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.
Measured: Baseline
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?
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.
Measured: Baseline and final visit (week 12)
Young Mania Rating Scale (YMRS) Scores (Bipolar Population): Change From Baseline
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.
Measured: Baseline to final visit (12 weeks)
Montgomery Asberg Depression Rating Scale (MADRS) Scores (Bipolar Population): Change From Baseline
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.
Measured: Baseline to final visit (12 weeks)
Clinical Global Impressions Change (CGI-C) Scores (Bipolar Population)
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.
Measured: Final visit (week 12)
Clinical Global Impressions Change (CGI-C) Scores (Schizoprenia Population)
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.
Measured: Final visit (week 12)
Brief Psychiatric Rating Scale (BPRS) Scores (Schizophrenia Population): Change From Baseline
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.
Measured: Baseline to final visit (week 12)
Extrapyramidal Symptom (EPS) Scores (Schizophrenia Population: Baseline and Final Visit
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.
Measured: Baseline and final visit (week 12)
Global Efficacy Evaluation Scores (Bipolar Population)
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.
Measured: Final visit (week 12)
Global Efficacy Evaluation Scores (Schizophrenia Population)
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.
Measured: Final visit (week 12)
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?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Last Week Have You Seen a Friend?
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.
Measured: Baseline and final visit (week 12)
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?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
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.
Measured: Baseline and final visit (week 12)
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?
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.
Measured: Baseline and final visit (week 12)
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?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?
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.
Measured: Baseline and final visit (week 12)
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?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Last Week Have You Seen a Friend?
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.
Measured: Baseline and final visit (week 12)
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?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?
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.
Measured: Baseline and final visit (week 12)
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?
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.
Measured: Baseline and final visit
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?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
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.
Measured: Baseline and final visit (week 12)
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?
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.
Measured: Baseline to final visit (week 12)
Clinical Global Impression of Severity (CGI-S) Scores (Schizophrenia Population)
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.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Oct 200730 Apr 2008

First posted2 Oct 2007 (estimated)
Study start16 Oct 2007
Primary completion30 Apr 2008
Study completion30 Apr 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bipolar DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 471 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00538629
Sponsor's protocol ID: A1281171
Status last verified: Nov 2022
First submitted: 1 Oct 2007
Last updated: 18 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Bipolar Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: NON INTERVENTIONAL STUDY (NIS) IN PATIENTS WITH BIPOLAR DISCORDER (MANIC OR MIXED EPISODES) AND SCHIZOPHRENIA UNDERGOING TREATEMENT WITH ZELDOX
ClinicalTrials.gov ID: NCT00538629
Acronym / sponsor ID: A1281171
Conditions: Bipolar Disorder, Schizophrenia
Study type: Observational
Recruitment status: Completed
Enrolment: 471 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: 16 Oct 2007 (actual)
Primary completion: 30 Apr 2008 (actual)
Study completion: 30 Apr 2008 (actual)
First posted: 2 Oct 2007 (estimated)
Results: Posted 19 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Investigation of the impact of Zeldox on metabolic parametres in patients with bipolar disorder or with schizophrenia and impact of the treatment for the quality of life

Detailed description

observational survey consecutive patient sampling

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
schizophrenic	–	Other: no interventionpatients with schizophrenia
bipolar disorder	–	Other: no interventionpatients with bipolar disorder

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: psychiatric outpatients

Key inclusion criteria (1 listed)

Manic and mixed episodes of up to moderate severity in patients with type I and II bipolar disorder and schizophrenia; either first diagnosed or repeated episodes.

Key exclusion criteria (1 listed)

Patients with a history of hypersenzitivity to Ziprasidone. Previous insufficiency of the Ziprasidone´s treatment. The break of the previous therapeutic condition.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
no interventionno intervention	Other	schizophrenic
no interventionno intervention	Other	bipolar disorder

Primary outcome

Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population)
Time frame: Baseline
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?
Time frame: Baseline and final visit (week 12)
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.
Young Mania Rating Scale (YMRS) Scores (Bipolar Population): Change From Baseline
Time frame: Baseline to final visit (12 weeks)
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.
Montgomery Asberg Depression Rating Scale (MADRS) Scores (Bipolar Population): Change From Baseline
Time frame: Baseline to final visit (12 weeks)
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.
Clinical Global Impressions Change (CGI-C) Scores (Bipolar Population)
Time frame: Final visit (week 12)
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.
Clinical Global Impressions Change (CGI-C) Scores (Schizoprenia Population)
Time frame: Final visit (week 12)
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.
Brief Psychiatric Rating Scale (BPRS) Scores (Schizophrenia Population): Change From Baseline
Time frame: Baseline to final visit (week 12)
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.
Extrapyramidal Symptom (EPS) Scores (Schizophrenia Population: Baseline and Final Visit
Time frame: Baseline and final visit (week 12)
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.
Global Efficacy Evaluation Scores (Bipolar Population)
Time frame: Final visit (week 12)
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.
Global Efficacy Evaluation Scores (Schizophrenia Population)
Time frame: Final visit (week 12)
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.
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?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Job?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: In the Last Week Have You Seen a Friend?
Time frame: Baseline and final visit (week 12)
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.
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?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Accomodation?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Time frame: Baseline and final visit (week 12)
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.
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?
Time frame: Baseline and final visit (week 12)
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.
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?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With the People You Live With?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Sex Life?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Health?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Bipolar Population) in Answer to: How Satisfied Are You With Your Mental Health?
Time frame: Baseline and final visit (week 12)
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.
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?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Job?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores(Schizophrenia Population) in Answer to: How Satisfied Are You With Your Financial Situation?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: Do You Have Anyone You Would Call a Close Friend?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: In the Last Week Have You Seen a Friend?
Time frame: Baseline and final visit (week 12)
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.
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?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Leisure Activities?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Accomodation?
Time frame: Baseline and final visit (week 12)
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.
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?
Time frame: Baseline and final visit
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.
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?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Personal Safety?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With the People You Live With?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Sex Life?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Relationship With Your Family?
Time frame: Baseline and final visit (week 12)
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.
Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Health?
Time frame: Baseline to final visit (week 12)
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.
Clinical Global Impression of Severity (CGI-S) Scores (Schizophrenia Population)
Time frame: Baseline
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.

Results and safety

Results posted to the registry on 19 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ziprasidone	471	449

Primary outcome: Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population)

Time frame: Baseline. Number. Unit: Participants

Measure	Ziprasidone n = 222
(1) Normal, not ill	3
(2) Borderline mentally ill	5
(3) Mildly ill	19
(4) Moderately ill	57
(5) Absolutely clearly ill	101
(6) Severely ill	24
(7) Among the most extremely ill subjects	0
Missing	13

Population analysed: The bipolar full analysis set included all subjects with a diagnosis of bipolar mania who had received at least 1 dose of study medication.

Primary outcome: Manchester Short Assessment of Quality of Life (MANSA) Scores (Schizophrenia Population) in Answer to: How Satisfied Are You With Your Mental Health?

Time frame: Baseline and final visit (week 12). Number. Unit: Participants

Measure	Ziprasidone n = 176
Baseline: Could not be worse	13
Baseline: Displeased	45
Baseline: Mostly dissatisfied	36
Baseline: Mixed	44
Baseline: Mostly satisfied	19
Baseline: Pleased	17
Baseline: Could not be better	2
Baseline: Missing	68

Population analysed: 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.

Primary outcome: Young Mania Rating Scale (YMRS) Scores (Bipolar Population): Change From Baseline

Time frame: Baseline to final visit (12 weeks). Mean (Standard Deviation). Unit: Score on scale

Measure	Ziprasidone n = 208
Baseline	26.6 (12.6)
Final visit	10.8 (8.3)
Change from baseline	-15.6 (9.4)

Population analysed: 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.

Primary outcome: Montgomery Asberg Depression Rating Scale (MADRS) Scores (Bipolar Population): Change From Baseline

Time frame: Baseline to final visit (12 weeks). Mean (Standard Deviation). Unit: Score on scale

Measure	Ziprasidone n = 214
Baseline	26.2 (20.3)
Final visit	11.6 (9.1)
Change from baseline	-14.6 (16.1)

Population analysed: 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.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ziprasidone	0 of 471 (0%)	15 of 471 (3.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Bipolar Disorder and Schizophrenia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population) (time frame: Baseline). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00538629.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.