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

Completed

• Conditions: Bipolar Disorder
• Interventions: Other: non-interventional

• Registration Number: NCT00584961
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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 Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-02
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 553

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
600 patients	non-interventional	Patients with diagnosis of Bipolar Disorder (DSM-IV TR)

Primary Outcome Measures

Name	Time	Method
Clinical Evolution of the Disease	12 months
Evolution of Modifiable Metabolic and Cardiovascular Risk Factors (Weight, and serum levels of Glucose, Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol and Triglycerides)	12 months
Cardiovascular Risk	12 months

Secondary Outcome Measures

Name	Time	Method
Patient functional impairment	12 months
Patient quality of life	12 month
Current pattern of treatment in Bipolar Disorder	12 month
Prevalence of Metabolic Syndrome in Spanish Population with Bipolar Disorder	1 day