Noninterventional Study in Bipolar Disorder and Schizophrenia With Zeldox

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NCT00538629

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bipolar Disorder, Schizophrenia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients with a history of hypersensitivity to Ziprasidone.


- Previous insufficiency of the Ziprasidone´s treatment.


- The break of the previous therapeutic condition.

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Advanced Information
Descriptive Information
Brief Title Noninterventional Study in Bipolar Disorder and Schizophrenia With Zeldox
Official Title Noninterventional Study (NIS) in Patients With Bipolar Disorder (Manic or Mixed Episodes) and Schizophrenia Undergoing Treatment With Zeldox
Brief Summary 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.
Detailed Description Observational survey consecutive patient sampling.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Psychiatric outpatients
Condition
  • Bipolar Disorder
  • Schizophrenia
Intervention Other: no intervention
No intervention
Study Groups/Cohorts
  • Schizophrenia
    Patients with schizophrenia
    Intervention: Other: no intervention
  • Bipolar disorder
    Patients with bipolar disorder
    Intervention: Other: no intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 8, 2009)		471
Original Enrollment
 (submitted: October 1, 2007)		500
Actual Study Completion Date April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00538629
Other Study ID Numbers A1281171
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure, Pfizer Inc
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2009