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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
History of Changes

December 21, 2007
February 9, 2010
May 2007
February 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00584961 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Prevalence of Metabolic Syndrom 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 ]
  • Current pattern of treatment in Bipolar Disorder [ Time Frame: 12 month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder
BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder

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.

Consecutive patient sampling. In any investigational site, five consecutive patients with diagnosis of Bipolar Disorder will be enrolled in the study
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Community sample. Patients >17 years older with diagnosis of Bipolar Disorder (DSM-IV TR)
Bipolar Disorder
Other: non-interventional
non-interventional
600 patients
Patients with diagnosis of Bipolar Disorder (DSM-IV TR)
Intervention: Other: non-interventional
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
553
February 2009
February 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00584961
A1281161
No
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP