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Noninterventional Study in Bipolar Disorder and Schizophrenia With Zeldox

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00538629
First Posted: October 2, 2007
Last Update Posted: August 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
Investigation of the impact of Zeldox on metabolic parameters in patients with bipolar disorder or with schizophrenia and the impact of the treatment with quality of life.

Condition Intervention
Bipolar Disorder Schizophrenia Other: no intervention

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Noninterventional Study (NIS) in Patients With Bipolar Disorder (Manic or Mixed Episodes) and Schizophrenia Undergoing Treatment With Zeldox

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Clinical Global Impression of Severity (CGI-S) Scores (Bipolar Population) [ Time Frame: Baseline ]
  • Clinical Global Impression of Severity (CGI-S) Scores (Schizophrenia Population) [ Time Frame: Baseline ]
  • Young Mania Rating Scale (YMRS) Scores (Bipolar Population): Change From Baseline [ Time Frame: Baseline to final visit (12 weeks) ]
  • Montgomery Asberg Depression Rating Scale (MADRS) Scores (Bipolar Population): Change From Baseline [ Time Frame: Baseline to final visit (12 weeks) ]
  • Clinical Global Impressions Change (CGI-C) Scores (Bipolar Population) [ Time Frame: Final visit (week 12) ]
  • Clinical Global Impressions Change (CGI-C) Scores (Schizoprenia Population) [ Time Frame: Final visit (week 12) ]
  • Brief Psychiatric Rating Scale (BPRS) Scores (Schizophrenia Population): Change From Baseline [ Time Frame: Baseline to final visit (week 12) ]
  • Extrapyramidal Symptom (EPS) Scores (Schizophrenia Population: Baseline and Final Visit [ Time Frame: Baseline and final visit (week 12) ]
  • Global Efficacy Evaluation Scores (Bipolar Population) [ Time Frame: Final visit (week 12) ]
  • Global Efficacy Evaluation Scores (Schizophrenia Population) [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: 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? [ Time Frame: Baseline to final visit (week 12) ]
  • 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) ]

Enrollment: 471
Study Start Date: October 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Schizophrenia
Patients with schizophrenia
Other: no intervention
No intervention
Bipolar disorder
Patients with bipolar disorder
Other: no intervention
No intervention

Detailed Description:
Observational survey consecutive patient sampling.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Psychiatric outpatients
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with a history of hypersensitivity to Ziprasidone.
  • Previous insufficiency of the Ziprasidone´s treatment.
  • The break of the previous therapeutic condition.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538629


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00538629     History of Changes
Other Study ID Numbers: A1281171
First Submitted: October 1, 2007
First Posted: October 2, 2007
Results First Submitted: April 30, 2009
Results First Posted: August 19, 2009
Last Update Posted: August 25, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Disease
Schizophrenia
Bipolar Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders