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Trial record 1 of 1 for:    NCT00584961
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BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder (BIMET)

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ClinicalTrials.gov Identifier: NCT00584961
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : February 10, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date December 21, 2007
First Posted Date January 2, 2008
Last Update Posted Date February 10, 2010
Study Start Date May 2007
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 21, 2007)
  • 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 ]
  • Clinical Evolution of the Disease [ Time Frame: 12 months ]
  • Cardiovascular Risk [ Time Frame: 12 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00584961 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 25, 2008)
  • Current pattern of treatment in Bipolar Disorder [ Time Frame: 12 month ]
  • Prevalence of Metabolic Syndrome in Spanish Population with Bipolar Disorder [ Time Frame: 1 day ]
  • Patient functional impairment [ Time Frame: 12 months ]
  • Patient quality of life [ Time Frame: 12 month ]
Original Secondary Outcome Measures
 (submitted: December 21, 2007)
  • Prevalence of Metabolic Syndrom in Spanish Population with Bipolar Disorder [ Time Frame: 1 day ]
  • Patient functional impairment [ Time Frame: 12 months ]
  • Patient quality of life [ Time Frame: 12 month ]
  • Current pattern of treatment in Bipolar Disorder [ Time Frame: 12 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder
Official Title BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder
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.

Detailed Description Consecutive patient sampling. In any investigational site, five consecutive patients with diagnosis of Bipolar Disorder will be enrolled in the study
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Community sample. Patients >17 years older with diagnosis of Bipolar Disorder (DSM-IV TR)
Condition Bipolar Disorder
Intervention Other: non-interventional
non-interventional
Study Groups/Cohorts 600 patients
Patients with diagnosis of Bipolar Disorder (DSM-IV TR)
Intervention: Other: non-interventional
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 9, 2010)
553
Original Estimated Enrollment
 (submitted: December 21, 2007)
600
Actual Study Completion Date February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00584961
Other Study ID Numbers A1281161
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2010