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Noninterventional Study in Bipolar Disorder and Schizophrenia With Zeldox

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
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.

NCT00538629
Pfizer
Completed
Noninterventional Study in Bipolar Disorder and Schizophrenia With Zeldox

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Descriptive Information
Brief TitleNoninterventional Study in Bipolar Disorder and Schizophrenia With Zeldox
Official TitleNoninterventional Study (NIS) in Patients With Bipolar Disorder (Manic or Mixed Episodes) and Schizophrenia Undergoing Treatment With Zeldox
Brief SummaryInvestigation 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 DescriptionObservational survey consecutive patient sampling.
Study TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationPsychiatric outpatients
Condition
  • Bipolar Disorder
  • Schizophrenia
InterventionOther: 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 StatusCompleted
Actual Enrollment
 (submitted: July 8, 2009)
471
Original Enrollment
 (submitted: October 1, 2007)
500
Actual Study Completion DateApril 2008
Actual Primary Completion DateApril 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
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00538629
Other Study ID NumbersA1281171
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyDirector, Clinical Trial Disclosure, Pfizer Inc
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJuly 2009

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now