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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00584961
First received: December 21, 2007
Last updated: February 9, 2010
Last verified: February 2010
  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

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

Resource links provided by NLM:


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 ]

Enrollment: 553
Study Start Date: May 2007
Study Completion Date: February 2009
Primary Completion Date: February 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00584961     History of Changes
Other Study ID Numbers: A1281161
Study First Received: December 21, 2007
Last Updated: February 9, 2010
Health Authority: Spain: Ethics Committee

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

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014