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

Bipolar Disorder Clinical Trial

— BIMET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00584961
• Other study ID #: A1281161
• Status: Completed
• Start date: May 2007
• Est. completion date: February 2009

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Consecutive patient sampling. In any investigational site, five consecutive patients with diagnosis of Bipolar Disorder will be enrolled in the study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 553
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

Other:
• non-interventional
non-interventional

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of Modifiable Metabolic and Cardiovascular Risk Factors (Weight, and serum levels of Glucose, Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol and Triglycerides)		12 months
Primary	Clinical Evolution of the Disease		12 months
Primary	Cardiovascular Risk		12 months
Secondary	Current pattern of treatment in Bipolar Disorder		12 month
Secondary	Prevalence of Metabolic Syndrome in Spanish Population with Bipolar Disorder		1 day
Secondary	Patient functional impairment		12 months
Secondary	Patient quality of life		12 month

External Links

•   To obtain contact information for a study center near you, click here.