BIMET Study: Evolution of Metabolic and Cardiovascular Ri... | NCT00584961

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

NCT00584961

Sponsor

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

Status

Completed

Last Update Posted

Feb 21, 2021Actual

Enrollment

553Actual

Phase

Not provided

Conditions

Bipolar Disorder

Interventions

non-interventional

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Dec 21, 2007

First Submission Date that Met QC Criteria

Dec 21, 2007

First Posted Date

Jan 2, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2021

Last Update Posted Date

Feb 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

553Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
600 patients		Patients with diagnosis of Bipolar Disorder (DSM-IV TR)	Other: non-interventional

Interventions

Name	Type	Description	Arm Group Labels	Other Names
non-interventional	Other	non-interventional	600 patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Current pattern of treatment in Bipolar Disorder		12 month
Prevalence of Metabolic Syndrome in Spanish Population with Bipolar Disorder		1 day
Patient functional impairment

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Community sample. Patients >17 years older with diagnosis of Bipolar Disorder (DSM-IV TR)

Sampling Method

Probability Sample

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

References Module

Citations

Not provided

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders
D007333	Insulin Resistance