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
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 April 16, 2014