BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00584961

Purpose

To assess the prevalence of Metabolic Syndrome in Spanish population with Bipolar I or II Disorder.

To analyse the clinical progress disease in patients with Bipolar I or II Disorder for 12 months using the assessment of the symptoms disease and the progress of metabolic and cardiovascular risk. To analyse the health status, quality of life and functioning/disability of patients.

Condition	Intervention
Bipolar Disorder	Other: non-interventional

MedlinePlus related topics: Bipolar Disorder Cholesterol

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder

Further study details as provided by Pfizer:

Primary Outcome Measures:

Evolution of Modifiable Metabolic and Cardiovascular Risk Factors (Weight, and serum levels of Glucose, Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol and Triglycerides) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Clinical Evolution of the Disease [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Cardiovascular Risk [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Current pattern of treatment in Bipolar Disorder [ Time Frame: 12 month ] [ Designated as safety issue: No ]
Prevalence of Metabolic Syndrome in Spanish Population with Bipolar Disorder [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Patient functional impairment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Patient quality of life [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	600
Study Start Date:	May 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
600 patients Patients with diagnosis of Bipolar Disorder (DSM-IV TR)	Other: non-interventional non-interventional

Detailed Description:

Consecutive patient sampling. In any investigational site, five consecutive patients with diagnosis of Bipolar Disorder will be enrolled in the study

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Community sample. Patients >17 years older with diagnosis of Bipolar Disorder (DSM-IV TR)

Criteria

Inclusion Criteria:

Patients with diagnosis of Bipolar Disorder (DSM-IV TR)
Patients or their legal representatives have provided informed consent

Exclusion Criteria:

Patients are unable to complete or to understand health questionnaires in Spanish language
Patients enrolled in clinical trials or other studies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584961

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1281161
Study First Received:	December 21, 2007
Last Updated:	February 27, 2009
ClinicalTrials.gov Identifier:	NCT00584961 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines (not required)

Keywords provided by Pfizer:

Metabolic Syndrome, Bipolar Disorder and Cardiovascular Risk Factors

Study placed in the following topic categories:

Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Mood Disorders
Psychotic Disorders

Additional relevant MeSH terms:

Affective Disorders, Psychotic
Pathologic Processes
Disease

Mental Disorders
Bipolar Disorder
Mood Disorders

ClinicalTrials.gov processed this record on May 07, 2009