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

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00584961
• Collaborator: (none)
• Enrollment: 553
• Duration (Months): 21.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Other: 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

Study Design

• Study Type: Observational
• Actual Enrollment: 553 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: BIMET Study: Evolution of Metabolic and Cardiovascular Risks Factors in Patients With Bipolar Disorder
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
600 patients Patients with diagnosis of Bipolar Disorder (DSM-IV TR)	Other: non-interventional; non-interventional

Outcome Measures

Primary Outcome Measures

1. Evolution of Modifiable Metabolic and Cardiovascular Risk Factors (Weight, and serum levels of Glucose, Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol and Triglycerides) [12 months]

2. Clinical Evolution of the Disease [12 months]

3. Cardiovascular Risk [12 months]

Secondary Outcome Measures

1. Current pattern of treatment in Bipolar Disorder [12 month]

2. Prevalence of Metabolic Syndrome in Spanish Population with Bipolar Disorder [1 day]

3. Patient functional impairment [12 months]

4. Patient quality of life [12 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00584961
• Other Study ID Numbers: A1281161
• First Posted: Jan 2, 2008
• Last Update Posted: Feb 21, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: Metabolic Syndrome, Bipolar Disorder and Cardiovascular Risk Factors
• Additional relevant MeSH terms: Disease; Bipolar Disorder

Study Results

No Results Posted as of Feb 21, 2021