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BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder (BIMET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00584961
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : February 10, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Bipolar Disorder Other: 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

Study Design

Study Type : Observational
Actual Enrollment : 553 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder
Study Start Date : May 2007
Primary Completion Date : February 2009
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
600 patients
Patients with diagnosis of Bipolar Disorder (DSM-IV TR)
Other: non-interventional
non-interventional


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. Clinical Evolution of the Disease [ Time Frame: 12 months ]
  3. Cardiovascular Risk [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Current pattern of treatment in Bipolar Disorder [ Time Frame: 12 month ]
  2. Prevalence of Metabolic Syndrome in Spanish Population with Bipolar Disorder [ Time Frame: 1 day ]
  3. Patient functional impairment [ Time Frame: 12 months ]
  4. Patient quality of life [ Time Frame: 12 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584961


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00584961     History of Changes
Other Study ID Numbers: A1281161
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: February 10, 2010
Last Verified: February 2010

Keywords provided by Pfizer:
Metabolic Syndrome, Bipolar Disorder and Cardiovascular Risk Factors

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders