Noninterventional Study in Bipolar Disorder and Schizophrenia With Zeldox
NCT00538629
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- 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.
- 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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Descriptive Information | ||||
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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 |
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Intervention | Other: no intervention
No intervention | |||
Study Groups/Cohorts |
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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 | 471 | |||
Original Enrollment | 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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | Pfizer | |||
Verification Date | July 2009 |