Non Interventional Study in Bipolar Disorder and Schizophrenia With Zeldox - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00538629

Purpose

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

Condition	Intervention
Bipolar Disorder Schizophrenia	Other: no intervention

MedlinePlus related topics: Bipolar Disorder Schizophrenia

Drug Information available for: Ziprasidone Ziprasidone hydrochloride Ziprasidone mesylate

U.S. FDA Resources

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

Further study details as provided by Pfizer:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	460
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
bipolar disorder patients with bipolar disorder	Other: no intervention no intervention
schizophrenic patients with schizophrenia	Other: no intervention no intervention

Detailed Description:

observational survey consecutive patient sampling

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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 hypersenzitivity to Ziprasidone. Previous insufficiency of the Ziprasidone´s treatment. The break of the previous therapeutic condition.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538629

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure )
Study ID Numbers:	A1281171
Study First Received:	October 1, 2007
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00538629
Health Authority:	Czech Republic: State Institute for Drug Control

Study placed in the following topic categories:

Schizophrenia
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder

Mood Disorders
Psychotic Disorders
Ziprasidone
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009